text:
The Abbey Lodge Hotel
62 Kirkgate, Bradford, BD18 3EL, United Kingdom – Great location - show map
Nothing was too much trouble - booked family room for my daughter and grandchildren which was really spacious.
United Kingdom
The staff were all amazing - can't praise them enough!
United Kingdom
The staff were very helpful, polite & engaging. The room was smaller than the last time we stayed there, so was a little cramped with the dog. But overall very nice stay. Shower, very nice.
United Kingdom
The bedroom was beautiful made use of the jacuzzi bath in the room too. My mam and Dad thoroughly enjoyed their stay here.
United Kingdom
Lovely Hotel staff very pleasant and helpful especially the kind night porter location fab third visit and will definitely be back
United Kingdom
Good size room, especially full size 3rd bed Excellent breakfast
United Kingdom
Welcoming staff, clean well decorated room, excellent value for money
United Kingdom
Welcoming staff,lovely clean hotel and the room and bathroom was exceptional. Excellent breakfast and again friendly staff. Enjoyed staying here and would recommend fully with no hesitation and would stay again whilst in the area.
United Kingdom
Well run hotel staff couldnt be more helpful will recommend to friends
United Kingdom
As soon as I walked in I was made welcome by all the staff, room was perfect and the food was excellent, couldn't fault it definitely stay there again. 😃
United Kingdom
One of our bestsellers in Bradford! The Abbey Lodge Hotel is located in the Yorkshire town of Shipley, 5 miles from Bradford. It offers boutique rooms with HD LCD TVs, a 24-hour reception and free parking.
Rooms at the Abbey Lodge are decorated in light shades and feature comfortable beds with Egyptian cotton sheets. They also include spacious work areas, Sky TV channels and bathrooms with power showers, hairdryers and free toiletries.
Each morning cooked English, continental and vegetarian breakfasts are available. The bar has a selection of hot and cold snacks, a range of beers and wines and free Wi-Fi is available in public areas of the hotel.
Shipley Train Station is a 10-minute walk away, whilst the World Heritage Site of Saltaire is less 1 miles from the property. The beautiful Yorkshire Dales are within a 15-minute drive of the hotel.
This property also has one of the best-rated locations in Bradford! Guests are happier about it compared to other properties in the area.
This property is also rated for the best value in Bradford! Guests are getting more for their money when compared to other properties in this city.
We speak your language!
Most popular facilities
Guests love it because...
"wonderful staff"
504 related reviews
"very clean and tidy"
311 related reviews
"excellent quality of food"
259 related reviews
Top location: Highly rated by recent guests (8.6)
Great Food: Meals here are highly recommended
Breakfast info
Full English/Irish
Free private parking available on-site
Loyal customers
There are more repeat guests here than most other properties.
Max | Room type | |
Single Room | ||
Double Room | ||
Twin Room | ||
Superior Double Room | ||
Family Room (3 Adults) |
Property surroundings – Great location - show map
Closest landmarks
- Bradford Royal Infirmary 2 miles
- Coral Windows Stadium 2.3 miles
- University of Bradford 3 miles
- Bradford City Library 3 miles
- The Alhambra Theatre 3.1 miles
- St George's Hall 3.1 miles
- National Media Museum 3.1 miles
- Bingley St Ives Golf Club Ltd 3.3 miles
- Park Square 4.3 miles
- Odsal Stadium 4.8 miles
Most popular landmarks
- Kirkstall Abbey 6.9 miles
- Victoria Theatre 8.4 miles
- Leeds Town Hall 9.7 miles
- 02 Academy 9.8 miles
- Leeds City Railway Station 10 miles
- Leeds Arena 10 miles
- White Rose Shopping Centre 10 miles
- Trinity Leeds 10 miles
- Roundhay Park 10.8 miles
- Middleton Park 11.3 miles
Restaurants and markets
- Asda Supermarket 0.3 miles
Closest airports
- Leeds Bradford International Airport 5.6 miles
- Manchester Airport 38.3 miles
- Robin Hood Airport Doncaster Sheffield 40.1 miles
What would you like to know?
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Retry6 reasons to choose The Abbey Lodge Hotel
Prices you can't beat!
Manage your bookings online
They speak 3 languages
Booking is safe
Guests loved the "boutique" style
Facilities of The Abbey Lodge Hotel Great facilities! Review score, 8.6
Pets are allowed on request. Charges may be applicable.
Food & Drink
- Bar
- Restaurant
Free! WiFi is available in the hotel rooms and is free of charge.
Free! Free private parking is possible on site (reservation is not needed).
- Luggage storage
- Fax/photocopying
- Packed lunches
- 24-hour front desk
- Meeting/banquet facilities
- Non-smoking throughout
- Heating
- Newspapers
Languages spoken
- Polish
- English
- Arabic
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14:00 - 00:00 hours
Until 11:00 hours
Cancellation and prepayment policies vary according to room type. Please enter the dates of your stay and check the conditions of your required room.
Children and extra beds
All children are welcome.
All children under 5 years stay free of charge when using existing beds.
All children under 2 years are charged GBP 5 per stay for children's cots/cribs.
There is no capacity for extra beds in the room.
The maximum number of children's cots/cribs in a room is 1.
Supplements are not calculated automatically in the total costs and will have to be paid for separately during your stay.
Pets are allowed on request. Charges may be applicable.
Cards accepted at this property
Hover over the cards for more info.
Or, take a look at these appealing alternatives:
- Orchard & Avenue Serviced Apartments has a location score of 9.4


text:
Blogging at Townhall.com
Hi everyone,Just wanted to let old and new readers know that I am now blogging full time at townhall.com, as part of my duties as the Townhall.com Associate Editor and Online Community Manager. I have a couple posts on the news of Castro's hospitalization. Check it out.
Go to http://josue.townhall.com

subset: commoncrawl


text:
Keeping all of this in mind and watching the clock to make sure that my family wasn't going to be late for church, I whipped up a batch of my family's favorite Old Bay Deviled Eggs in addition to a few Pesto Deviled Eggs. I kept the basic ingredients like mayonnaise, mustard, and pickle juice the same, but then placed a fourth of the mixture into a separate bowl and added a few tablespoons of my prepared pesto to it.
The pesto turned the yolk mixture a pleasant shade of green that contrasted nicely with the whites while at the same time adding a nice tangy flavor to the creamy filling. At our Easter dinner today, none of the kids chose to brave the Pesto Deviled Eggs ("not in a house, not with a mouse, I will not eat them Sam I am, I will not eat green deviled eggs and ham"), but the adults who tried them seemed pleasantly surprised.
I was thrilled with my Pesto Deviled Eggs! It was nice to be inspired by a random ingredient this morning. The taste of the basil added a Springy touch to my Easter meal. I loved the contrast that it brought to my not-green ham, Baked Macaroni and Cheese, Strawberry Pretzel Salad, and grilled asparagus. Change is good once in a while, even with deviled eggs. Happy Easter!
Pesto Deviled Eggs
(makes 12 deviled eggs)
6 eggs, room temperature
1/4 - 1/2 cup mayonnaise
1 Tablespoon yellow mustard
1-2 Tablespoons dill pickle juice
2 Tablespoons Pesto (fresh or prepared, add more to taste)
1/2 teaspoon Kosher salt
1/4 teaspoon pepper
- Place room temperature eggs in a saucepan; add enough cold water to come at least 1 inch above the eggs. Heat water and eggs to rapidly boiling. Turn off heat. Cover saucepan and let stand for 15 minutes. Immediately cool eggs in cold ice water to prevent further cooking.
- Peel eggs. Tap egg to crack shell. Roll egg on counter to loosen shell, then peel. Hold egg under running cold water to help ease off shell (add your egg shells to your garden or compost pile).
- Cut peeled eggs lengthwise into halves with a sharp knife wiping egg yolk off knife blade as needed. Slip yolks into a bowl. Mash yolks with a fork or a pastry blender. Use a fork to mix in mayonnaise (start with 1/4 cup), mustard, pickle juice (start with 2 Tablespoons), pesto, salt and pepper. Taste mixture for flavor and texture and adjust mayonaise and seasonings to your preference.
- Place yolk mixture into a large zip-lock bag. Snip a small part of one bottom corner off of the filled zip-lock.
- Arrange egg whites on a large platter or deviled egg plate. Squeeze yolk mixture into each egg white. Sprinkle the top of each egg with a tiny bit of Paprika or Old Bay Seasoning.
- Cover and chill eggs for at least one hour. Can be refrigerated for up to 24 hours.


text:
Today's poem is by Carl Adamshick
The confession of an apricot
I love incorrectly.
There is a solemnity in hands,
the way a palm will curve in
accordance to a contour of skin,
the way it will release a story.This should be the pilgrimage.
The touching of a source.
This is what sanctifies.This pleading. This mercy.
I want to be a pilgrim to everyone,
close to the inaccuracies, the astringent
dislikes, the wayward peace, the private
words. I want to be close to the telling.
I want to feel everyone whisper.After the blossoming I hang.
The encyclical that has come
through the branches
instructs us to root, to become
the design encapsulated within.Flesh helping stone turn tree.
I do not want to hold life
at my extremities, see it prepare
itself for my own perpetuation.
I want to touch and be touched
by things similar in this world.I want to know a few secular days
of perfection. Late in this one great season
the diffused morning light
hides the horizon of sea. Everything
the color of slate, a soft tablet
to press a philosophy to.
Copyright © 2011 Carl Adamshick All rights reserved
from Curses and Wishes
Louisiana State University Press
Reprinted by Verse Daily® with permission
Support Verse Daily
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Copyright © 2002-2011 Verse Daily
All Rights Reserved


text:
Please use this identifier to cite or link to this item:
Appears in Collections: | Aquaculture Journal Articles |
Peer Review Status: | Refereed |
Title: | The use of silages prepared from fish neural tissues as enrichers for rotifers (Brachionus plicatilis) and Artemia in the nutrition of larval marine fish |
Authors: | Tocher, Douglas R Mourente, Gabriel Sargent, John R |
Contact Email: | email@example.com |
Keywords: | Artemia rotifers docosahexaenoic acid lipids silage enrichment |
Issue Date: | 15-Jan-1997 |
Citation: | Tocher DR, Mourente G & Sargent JR (1997) The use of silages prepared from fish neural tissues as enrichers for rotifers (Brachionus plicatilis) and Artemia in the nutrition of larval marine fish, Aquaculture, 148 (2-3), pp. 213-231. |
Abstract: | Marine fish larvae have a requirement for large quantities of n − 3 highly unsaturated fatty acids (HUFA), particularly docosahexaenoic acid (DHA; 22:6n − 3), and dietary deficiencies of these induce a range of pathologies in fish including behavioural abnormalities. Therefore, there is a growing demand for natural lipids highly enriched in DHA as nutritional supplements during larval development. In the present study, DHA-rich products were obtained from fish neural tissues by a procedure involving ensiling in organic acids followed by neutralisation, drying, milling and sieving to produce the final paniculate, crumbed products. Lipid content varied in the neural tissue silages from 5.5% to 46.5% but all lipid contained high percentages of DHA and high DHA:EPA (eicosapentaenoic acid; 20:5n − 3) ratios ranging from 3.5 to 5.4. Tuna eye silage was a high lipid, high triacylglycerol (90.6% of total lipid) product and was particularly effective in increasing DHA content, outperforming a commercial product, in rotifer (Brachionus plicatilis) enrichment. Cod brain/eye silage had an intermediate content (18.2%) of lipid, which contained almost 50% as phospholipid, and proved as effective as a commercial enricher in increasing DHA content in Artemia nauplii. Moreover, Artemia nauplii, enriched with the cod brain/eye silage were more effective than nauplii enriched with a commercial enricher in increasing the DHA content of larval turbot brain. In conclusion, tuna eye and cod brain/eye silages are useful as enrichers of Artemia nauplii and rotifers for feeding marine fish larvae prior to weaning onto pelleted formulated |
DOI Link: | http://dx.doi.org/10.1016/S0044-8486(96)01396-8 |
Rights: | The publisher does not allow this work to be made publicly available in this Repository. Please use the Request a Copy feature at the foot of the Repository record to request a copy directly from the author. You can only request a copy if you wish to use this work for your own research or private study. |
Files in This Item:
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tocher_aquaculture148_1997.pdf | 1.38 MB | Adobe PDF | Under Embargo until 31/12/2999 Request a copy |
Note: If any of the files in this item are currently embargoed, you can request a copy directly from the author by clicking the padlock icon above. However, this facility is dependant on the depositor still being contactable at their original email address.
This item is protected by original copyright |
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If you believe that any material held in STORRE infringes copyright, please contact email@example.com providing details and we will remove the Work from public display in STORRE and investigate your claim.


text:
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text:
To enquire about the Odyssée please use our contact us page.
View our stocklist to view all of our current stock.
For more than 10 years, the Trigano Odyssée fills its users with enthusiasm thanks to its bright dimensions (almost 19 m²) and its setup time of 5 minutes (the awning uses the same frame as the cabin and opens in the same movement.
There's no need to carry or to setup a separate awning frame). The 2010 version is a great evolution of the classical model with new colours, a system of assistance which eases the opening, and a ground sheet within the awning.


text: Meet the 'Stay-at-Home Dude' He's the homemaker in a couple without kids By John Johnson, Newser Staff Posted Feb 5, 2013 4:09 PM CST Updated Feb 9, 2013 7:00 PM CST 54 comments Comments (Shutterstock) (Newser) – Finn Boulding is married, his wife has a great job, and he is the happy, unemployed-by-choice homemaker in the relationship. Not that unusual, right? Plenty of stay-at-home dads exist in the world. Except Boulding and his wife don't have kids, and they don't plan to have them. "I'm not just doing this temporarily until I find something meaningful to do," writes Boulding in an essay at Slate. "I'm actually a full-time homemaker ... not stay-at-home dad but stay-at-home dude." He cooks, he cleans, he mends clothes, he likes it. "As a result, when she is done with work—if I've managed my time well—the evenings and weekends are now totally open for us to relax together," writes Boulding, who once was on track to become a licensed architect. "Our circumstances may change and I may be forced to re-evaluate, but for now, feeling that the benefits far outweigh the professional cost, I want to be a great homemaker supporting a fantastic spouse." Read his full essay here. My Take on This Story Report a story error Show results without voting | 8% Hilarious 9% Intriguing 6% Depressing 62% Brilliant 2% Scary 13% Ridiculous


text:
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text:
Multipurpose light-weight twin-engine turbo-prop airplane
Начаты сертификационные испытания легкого многоцелевого самолета «Рысачок», созданного ГНПРКЦ«ЦСКБ-Прогресс» (изготовитель) и НКФ «Техноавиа» (разработчик).
- Multipurpose light-weight twin-engine turbo-prop airplane
- Multipurpose light-weight twin-engine turbo-prop airplane
- Multipurpose light-weight twin-engine turbo-prop airplane
- Multipurpose light-weight twin-engine turbo-prop airplane
- Multipurpose light-weight twin-engine turbo-prop airplane
- Multipurpose light-weight twin-engine turbo-prop airplane
Rysachok light-class two-engine airplane
The Rysachok light-class two-engine airplane is meant in the first place to be used as a training plane in the Russian Civil Aviation schools. Besides, the airplane can be used for the following:
- Transportation of ten passengers within a range of 2,000- km;
- Transportation of cargo with total mass of up to 1,500 kg;
- Landing of parachutists (15 sportsmen or 8 firemen);
- Patrolling land frontiers и sea borders, highways, oil and gas pipelines, power lines, etc.;
- Search and rescue including delivery and drop-off of rescue teams onto unprepared grounds chosen in flight or rescue team landing;
- Transportation of six bed patients on stretchers accompanied by a medical officer;
- Aero surveying and ecological monitoring.
In a training version, the plane can be used for:
- Route air navigation training;
- Training in airfield maneuvering;
- Training in all- weather instrument flying;
- Training in night-flying;
- Training in emergency operations including cases of an interrupted and prolonged takeoff, flight with partial and asymmetrical thrust;
- Training in operation of modern flying and navigation equipment.
As a transport airplane, Rysachok can fly between airfields with primitive soft-surface runways spaced 100 to 1,000 km apart. At that, the same plane can be used for patrolling, passengers, cargo, medical transportation and other purposes with minimum cabin adaptation.
Rysachok is able to:
- continue its takeoff and flight in case of one engine failure;
- provide high-level safety even in cases of emergency off-airfield landing or water landing.
Rysachok is built as a cantilever monoplane with low wings equipped with retractable tricycle equipped landing gear with large-size pneumatic tires. The plane's structure is simple, made of inexpensive aluminum alloys. Its cabin has a large cargo-and-passenger door. The plane has two Czech 750-horsepower М-601F turboprop engines with five-bladed propellers of AV-725 type.
Rysachok light-class two-engine airplane
Rysachok Key Specifications
Performance | |
Cruising speed |
250-400 km/h |
Flight altitude |
Up to 6,000 m |
Maximum time in flight |
7.5 h |
Takeoff run |
370 m |
Landing run (without reversal) |
600 m |
Effective flight range with maximum fuel at 3-km altitude with two pilots and 470-kg commercial load with 40-minute fuel reserve |
1,990 km |
Landing run (with reversal) |
350 m |
One-engine-out takeoff run at V1 speed |
800 m |
Weight | |
Take-off mass |
6,000 kg |
Empty weight |
3,850 kg |
Maximum commercial load |
1,490 kg |
Fuel |
1,496/1,197 l/kg |
Geometry | |
Wing span |
18 m |
Aspect ratio of the wing |
10 |
Wing area |
32.3 m2 |
Plane length |
12.44 m |


text: Item is not available Find Another One Others Looked At... WINCHESTER 70 PRE-64 FEATHERWEIGHT .30-0... SELLER: Elk Castle Shooting Sports 1 $1,799.99 WINCHESTER PRE-64 MODEL 70 MAGNUM .300 H... SELLER: Elk Castle Shooting Sports 1 $1,999.99 WINCHESTER MODEL 70 ENGRAVED PRE 64 SELLER: Dominic Calandrella 0 $3,000.00 Winchester Model 70 Extreme Weather .308... SELLER: Discount Tactical Supply 1 $1,099.95 Winchester Model 70 Extreme Weather 7mm-... SELLER: Discount Tactical Supply 1 $1,099.95 Winchester Model 70 Extreme Weather SS .... SELLER: Discount Tactical Supply 1 $1,099.95 Guns Rifles Winchester Rifles Modern Bolt Auto Single Model Pre Pre Target in . | 761 | 11 | Lc | 203.1297ms 70 Pre-64 Target in .243 For Sale from Perkiomen Gunworks | Positive feedback: 99% View | Verified Seller | 3191 Completed Sales View Sellers Items This item is no longer available. Description Shipping and Payment More Info Winchester M-70 Pre-64 TARGET .243 Win, 26 inch heavy bbl, gun dates 1956, 366xxx, scope blocks installed. Rate gun overall at 90-95%, wood has some minor handling marks, no cracks or gouges, blueing is 95%+ with only some bolt wear – see photos. Bore is perfect and gun shows normal light usage. Smooth high end non-Winchester adjustable trigger that breaks at 1 3/4 lbs currently. Everything else on rifle is original. Super clean shooter for someone – not a NIB collectable!! +S&H to your local FFL for transfer. To pay on line - go to - find item - put in your cart and check-out. All transactions will be charged a +2% maintenance fee. We will receive notice of your payment automatically. Then all we will need is for you to have your local transfer dealer fax, email or mail their FFL license copy to ship firearm. OR: To pay via mail with NO extra fees – email us and follow these directions: To commit to gun we need your full name, address and phone #. This will only be used to hold gun until your paperwork arrives. Will confirm back sale if you are the FIRST we hear from with this information. To commit to gun we need your full name, address and phone #. Will confirm back sale if you are the FIRST we hear from with this information. Most guns shipped lower 48 at $25.00 flat rate. Additional charges for special guns or heavier items will be stated in description or other text. Over night and hardcase shipping quoted. S&H is non-refundable for returns. Our listed price is for Check or Money order, all on line payments are subject to a +2% maintenance fee. Our web site= www.perk Trades Accepted: Trade plus cash deals are considered - email us with details - photos would be a plus.We never do "Even" trades. All on line payments are subject to a +2% maintenance fee. Browning and Kimber Direct Dealer with access to ten major distributors for most firearms. Visit our web site: www.perkiomengunworks.com Located in central Tennessee – we are open BY APPOINTMENT ONLY. Our GunsAmerica sales count is well over 2640 guns with many repeat customers - we would be happy to have you as a customer too!! Email is the best way to contact us right off one of our ads. We must be first come first served to be fair.Email committing to buy with your full name, address and phone # will hold the gun for you if you are the first to commit. A confirmation reply will be back to you ASAP with instructions and our full address. Our phone # is listed for those wishing to call. Condition: Used, Minor Wear Caliber: .243 Winchester Location: TN Share Item Item #: 998887063 Stock No.: 09017 FT This item is no longer available. Price: (Price reflects 3% cash discount.) This Seller Accepts Online Payment Shipping: $25.00 (or Arrange local transfer) Accepted Payment Methods: Returns: 3 Days Perkiomen Gunworks Seller Since: Feb. 2000 Seller Level: Trusted Seller This seller is an FFL City: Sparta State: TN Your Recently Viewed Items


text:
Управление бизнесом
Проектирование (GEP)
GMP в мире
GMP по разделам:
Фармацевтическая система качества
Сервисные системы
Чистые помещения
Технологический процесс
Контроль качества
Аутсорсинговая деятельность
Терминология GMP
Экологический менеджмент
О проекте
Проектирование фармацевтических производств
Новости и обсуждения на форуме:
С апреля 2017 воду для инъекций можно будет получать при помощи обратного осмоса, в сочетании с другими методами очистки Автор: Denys 19 мар 2016 00:13 Регуляторный орган Франции выявил 45 замечаний на заводе THERAVECTYS - VILLEJUIF Автор: Sergey 07 мар 2016 15:34 Инспекторат Польши выявил пять критических несоответствий на китайском заводе Chengdu Okay Pharmaceutical Co. Ltd. Автор: Sergey 07 мар 2016 15:15 French National Agency выявил два критических несоответствия в Dongying Tiandong Pharmaceutical Co., Ltd. Автор: Sergey 07 мар 2016 15:05 Chinese Heparin Manufacturer again involved in Falsification and GMP Non-Compliance Автор: Sergey 07 мар 2016 14:59 Новая версия приложения 16: Сертификация уполномоченным лицом и выпуск серии Автор: Sergey 10 янв 2016 19:36 В 2015 году Комитет ЕMA рекомендовал одобрить 93 новых препарата Автор: News 04 янв 2016 10:00 FDA установила рекорд по количеству одобренных препаратов в 2015 Автор: News 04 янв 2016 09:58 В 2015 году значительно увеличилось количество и стоимость сделок в фармацевтической отрасли Автор: Sergey 04 янв 2016 09:56 Чем украинские аптеки заменят лекарства Автор: News 04 янв 2016 09:53
Qualification Official requirements
Here you will find answers to the following questions:
Qualification is an essential part of a pharmaceutical manufacturer's quality assurance system; it should demonstrate that facilities are suitable for their intended use and should also guarantee that the medicinal products are of an appropriate quality. Qualification is, thus, a basic factor for drug product safety.
Holders of manufacturing authorisations must have rooms and facilities at their disposal that are suitable for the production, analysis and storage of the relevant medicinal products. The suitability of facilities must be checked (qualification) where they are to be used for the production of medicinal products for which quality is decisive.
In the following, equipment and facilities are considered as a whole and all points raised apply to both, even if only "facilities" are referred to. An item of equipment is an object that is characterised by its internal technical processes. A facility is the sum of all equipment used for a common purpose.
The head of production is responsible for the necessary qualification measures within his scope of duties. Other company-internal departments (e. g. Engineering or Research and Development) or external service providers (e. g. consultants, contract giver for contract manufacturers) may be involved. The manufacturer (holder of the manufacturing authorisation) is responsible for ensuring that the necessary resources are available.
Operations and facilities are obliged to comply with the EU Good Manufacturing Practise guidelines for medicinal products (GMP Guideline). Regarding the "qualification of equipment", chapter 3.34 of the GMP Guideline states: "Manufacturing equipment should be designed, located and maintained to suit its intended purpose." Annex 15 to the EU GMP Guideline (see chapter 19 Tools for Quality Assurance) specifies how this requirement must be implemented.
While the EU GMP Guideline itself and its appendices are not legally binding, the Guideline does represent an interpretation of the basic principles laid down in the EU 2003/94 directive. According to Article 4, Paragraph 1 of this directive, the manufacturer must ensure the conformance of all manufacturing operations with good manufacturing practice. According to Article 8, Paragraph 3 of the directive, premises and equipment must be checked to make sure they are suitable for carrying out critical manufacturing operations where product quality is concerned. (Qualification).
Member states have implemented the directive as national law. The requirements of the EU GMP Guideline and its appendices reflect state-of-the-art technology. In particular, the suitability of rooms and facilities as well as a guarantee that state-of-the-art production and analysis will be carried out are important prerequisites for the issue of a manufacturing authorisation. If the manufacturer is not able to demonstrate the suitability of facilities and equipment, the manufacturing authorisation may be withheld or withdrawn.
As only the principles of qualification and validation are shown in Annex 15 to the EU GMP Guideline, PIC/S document PI 006 entitled Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation may be used as an interpretation and implementation aid (chapter F.1 Recommendations on Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation (PIC/S PI 006)).
This document applies primarily to investigators in the PIC/S member states for whom it is intended as instructions for preparing an inspection and as an advanced training aid for qualification/validation. As, from the PIC/S viewpoint, this reflects the latest scientific and technological developments, valuable information may be found here for the industry regarding the implementation of the specifications in Annex 15.
The objective of all qualification work is always to verify the suitability of the facility or equipment for its intended purpose within defined limits, otherwise known as acceptance criteria. It follows that acceptance criteria must be defined before the qualification is carried out as they are core elements of every qualification plan. Requirements arising from batch production records, registration documentation, standards or risk analyses (as examples), may be referred to when setting up acceptance criteria.
If implementation of the qualification is assigned to third parties, responsibilities must be clearly defined. A suitable contract has to be drawn up that sets out the tasks and responsibilities of each party in writing. The head of production must make sure that qualification work is carried out based on the latest scientific and technological developments. The responsibility for compliance with drug-related legislation is not transferred with tasks when they are assigned but remains with the head of production.
There are many reasons why companies often use external services when carrying out qualification. Frequently there is insufficient in-house knowledge and experience or not enough personnel to carry out a state-of-the-art qualification project. This is a typical field for consultants whose activities range from providing one-off consultations through to full implementation of the qualification and accompanying documentation.
While the buying in of external expertise is permissible, and is also useful in many cases, it is often wrongly assumed that responsibility for the work can also be transferred to third parties as well as the work itself. Chapter 2.5.11 of PIC/S document PI 006 therefore expressly states that the contract giver is ultimately responsible for proper implementation of the validation work: "In such cases, the responsibility lies with the contract giver to ensure that the required standards of the quality of the work which is carried out, for programme control and for documentation are met."
In this context, a regulation in the American legal system is also drawn to your attention. Paragraph 211.34 of the Code of Federal Regulations (CFR) states: "Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training and experience or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address and qualifications of any consultants and the type of service they provide" (chapter D.1 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals).
Analogous to the regulations for the qualification of contract manufacturers and suppliers, pharmaceutical manufacturers should therefore also make sure at the outset that external consultants/service providers are capable of undertaking and documenting qualification work in accordance with the latest scientific and technological developments. The distribution of tasks and responsibilities for both parties should be described in a contract.
The GMP Guidelines for documentation apply in general for the layout and compilation of qualification documents (chapter 15.A Official requirements and chapter 15.B GMP-conforming documentation). The plans at all qualification stages must be authorised by the head of production and quality assurance.
The documentation should be retained for at least five years once the facility or equipment has been shut down. According to Annex 15, No. 2 of the EU GMP Guideline, a company's current qualification projects must be described in a validation master plan (chapter 7.F Validation master plan).
This is used by the manufacturer to determine the relevant basic principles and procedures for the qualification. It also defines the qualification deadlines and it may be used to estimate the necessary resources. Additionally, the validation master plan enables the GMP inspector to understand how the company approaches the qualification, and how the necessary activities are defined and organised.
Protocols must be used to define the detailed qualification regulations for each facility (see chapter 6.C Qualification documentation, chapter 6.E.1 Examples of IQ plans and chapter 6.F.1 Examples of OQ plans) and these must be authorised by the persons responsible.
The implementation of the individual qualification projects should be documented in corresponding reports according to the specifications of the qualification plan used as the basis. Subsequent deviations from the qualification plan, and particularly changes to the acceptance criteria or the test procedure, must be well founded and formally authorised. A qualification report always ends with a conclusion regarding the suitability of the facility concerned.
Once the qualification has been successfully completed, approval must be given in writing in order for the facility to be used in routine production. This approval may be granted by including the signature of the head of production in the qualification documentation.
The qualification of facilities and equipment is part of their life cycle (figure 1).
Figure 1 Qualification as part of the life cycle of facilities
The first stage of a qualification should be the design qualification (DQ). According to Annex 15, conformance of the design with the GMP requirements should be demonstrated and documented.
The design qualification encompasses the documentation of the planning phase including the decision as to which facility will be used. The DQ should define the requirements for the intended facility.
The requirements of the contract giver for the scope of supply and services (cf. figure 2) (user requirements) or the agreement with the contract acceptor regarding implementation and handling of the project (technical specification) are described in the design qualification documents.
Figure 2 Contents of the user requirements/technical specification as basis for the DQ
Contents of the design qualification (DQ)
1. Purpose of the equipment/facility
2. Legal requirements (laws, regulations, standards)
3. Design requirements
4. Requirements for the installation
5. Performance data
6. Facilities for control, regulation and measurement
7. Requirements for maintenance, cleaning and care
8. Evidence of the functionality of the equipment/facility, e. g. records of trial runs at the premises of the facility manufacturer (final acceptance documents)
9. Requirements for the accompanying documentation
10. Customer service
11. Necessary supplementations and modifications following award of contract
12. Installation schedule at premises of contract giver
Before acquiring a new facility, the manufacturer must first determine the requirements (processes, products, capacity) that must be catered for. A number of different areas at the company are usually involved in the assessment of requirements that may be used to derive an informal requirements profile for the new facility. This requirement profile is transferred to the user requirements. The requirements of users including all limit conditions must be described in the user requirements. It should be possible to qualify and test these requirements. The user specifications describe the economic, technical and organisational expectations of the contract giver in relation to a facility and they also define the objectives and purpose of the facility.
When compiling the user requirements, a differentiation should be made between essential (compulsory) requirements and desirable (optional) requirements. In practice, it will not be possible to implement all the ideas of the future operator. Whether a facility manufacturer for a specific facility can be found and whether he is capable of delivering a suitable quality always depends on the market situation. A thorough market analysis will therefore determine what offers are available. It is quite possible that changes to the user requirements may be required as a result of such an analysis as new aspects in relation to the design of the facility may come to light that could not be taken into account when the user requirements were compiled.
Not all suppliers in the market will be in a position to guarantee that the facility will be designed and produced according to the principles of Good Engineering Practice (GEP) as defined in the standards and guidelines (baselines) of the ISPE (International Society for Pharmaceutical Engineering): "Established engineering methods and standards that are applied throughout a project's 'life cycle' to deliver appropriate, cost-effective solutions". When selecting a suitable supplier, checks should not only be made to establish whether the manufacturer actually supplies the required facility, but also to determine whether the manufacturer can provide evidence that he is able to comply with the aforementioned principles of GEP. This check must be carried out as part of a supplier qualification and should also consider aspects of service such as support during qualification, instruction of operators and maintenance.
The user requirements are dispatched to suitable suppliers following the supplier qualification (chapter 18.G Inspection of suppliers). The suppliers compile a technical specification on the basis of the user requirements and forward this to the prospective customer as part of a quotation for the conclusion of a purchase contract.
The user requirements are detailed in the technical specification and the implementation requirements described in an extension with reference to specific approaches. A definition is given in the technical specification as to how the requirements are to be implemented and what is to be used to achieve this.
Basically, the design is determined to be qualified if the technical specification corresponds with the user requirements. A documented comparison of the technical specification by the manufacturer/supplier of the facility with the user requirements of the pharmaceutical manufacturer should demonstrate that at least the compulsory requirements have been satisfied.
Before the purchase contract is concluded, or before the facility is delivered, it may be necessary to make sure that the user requirements are complied with at the manufacturer's premises (Factory Acceptance Test, FAT - "The partial commissioning and qualification of equipment and/or systems prior to their shipment from the fabricator's site", ISPE). To do this, a visual inspection of the facility is carried out at the manufacturing site. If required, and if circumstances permit, suitable test runs are carried out.
The correct implementation of the aforementioned requirements when assembling/setting up the facility is documented in the installation qualification (IQ) (cf. figure 3).
The check of the installation is generally carried out on the basis of the requirements previously established during the design qualification.
The installation qualification should be carried out on new or modified buildings, systems and equipment as defined in the glossary of Annex 15: "The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturerґs recommendations".
The contents of figure 3 constitute the minimum requirement for the scope of the installation qualification.
Figure 3 Contents of the installation qualification (IQ) according to Annex 15
Installation qualification according to Annex 15
The installation qualification serves as a check of the documents that were required for the design qualification. These include the drawing of the facility, lists of settings, lists of components, instruction manuals, operating instructions, circuit diagrams, spare parts lists/wear parts list, maintenance and cleaning procedures, certificates (material, CE etc.), calibration documents, software and hardware documents and a list of product-contact parts (surfaces and materials). The documents must be correct, complete and up to date.
A visual examination is also carried out of the components delivered, to ensure fault-free workmanship, correct assembly and set-up, correct implementation of all utility connections, and connections with upstream and downstream machines.
The individual working steps should be carried out using inspection or work sheets (with a uniform layout) and the acceptance criteria established at the design qualification stage as a foundation.
All deviations or changes identified during the installation qualification must be documented to be used as the basis for assessing the need for the compilation of a defects list (including responsibilities and deadlines). The results are then listed in an appropriate form in the final report and comprehensively checked once again.
If it can be demonstrated that the installation of the facility corresponds with the relevant specifications, the installation qualification may be finalised with the signatures of the responsible persons.
The Operational Qualification (OQ) provides evidence that the facility is functioning on the basis of established parameters and within defined limits. The OQ is a testing process and therefore the test methods to be applied, as well as the acceptance criteria, must be defined and laid down in advance.
Annex 15 states that the installation qualification should be followed by the operational qualification and that the minimum scope of the operational qualification is based on knowledge of the process, systems, or the facility, and also tests that facilitate the definition of an upper and lower operating range. These tests should be carried out under worst-case conditions.
As no release is required for the installation qualification, this could be approved together with the operational qualification. For logical reasons, the operational qualification should only be started if no significant (quality-relevant) defects were found during the installation qualification.
The basis of the operational qualification is a risk analysis during which the critical parameters of the facility and the environmental conditions are assessed. All relevant measuring equipment must be properly calibrated prior to the operational qualification. The appropriate final acceptances for safety-relevant components/facilities should have been carried out. A preliminary draft of all instructions necessary for the operation of the facility should exist as a minimum requirement.
A practical test phase then follows during which the various functions are checked in detail. Depending on the facility, the environmental conditions may need to be checked. The implementation of the cleaning/disinfection and maintenance work should also be checked at this stage.
To check the functionality, a sufficient number of suitable test runs must be carried out based on predefined qualification protocols for the operational qualification. The implementation of these tests must be recorded in qualification reports (cf. figure 4).
Figure 4 Qualification protocol and report (OQ)
Qualification protocol (OQ)
Qualification report (OQ)
Efforts should be made to ensure that the conditions under which this test phase is carried out are as close to reality as possible, i. e. routine manufacturing conditions. The same personnel that will subsequently be responsible for operating the facility should be present at this trial run.
There are fundamental problems associated with the adoption of FAT test results for the OQ phase. If functional tests have already been carried out at the premises of the facility manufacturer as part of the FAT test (cf. chapter 3 Design Qualification (DQ)), these test results may only be adopted for the OQ phase if it can be proved that the test conditions at the facility manufacturer's premises are transferable to the operations of the pharmaceutical manufacturer (e. g. identical installation, test under realistic conditions) and that the test was based on an approved qualification protocol as shown in figure 4.
The operational qualification ends with a formal release which should also conclude the calibration and training as well as the final versions of the operating, cleaning and preventative maintenance instructions.
Once the operational qualification has been carried out, the check of the facility's suitability is generally complete; though it may still be necessary to carry out a performance qualification (PQ) for specific products or for facilities that are linked to systems. Annex 15 defines performance qualification as, "The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification." Therefore, the performance qualification, although more facility oriented, is a test procedure that from the beginning is concerned with individual processes. If systems are created through the assembly of individual equipment that is already qualified, the functionality of the overall system (as connected together) must also be checked. Generally, the performance qualification should only start once the installation qualification and operational qualification have been successfully concluded. In individual cases it may be logical to combine elements of the operational qualification with the performance qualification. According to Annex 15, the tests carried out during the performance qualification must use production material, or suitable alternatives; also, tests that incorporate the upper and lower operating ranges must be included.
A fundamental part of the PQ is performance testing of the facility with all production materials subsequently processed during routine operation. During this testing, it should be observed in particular whether specific materials have an effect on the performance criteria of the facility due to their individual properties. Where the bracketing principle (chapter 7.F Validation master plan) is applied during the risk analysis, all other materials used must be taken into account in addition to starting materials and packaging materials.
If the product properties in question are simulated when the performance qualification is carried out ("simulated product"), all possible product categories must be taken into account.
Upper and lower limits for production on the facility should ultimately be defined with reference to the respective criteria to be observed (moulding pressure, temperature, etc.) for all materials processed.
As is the case with all other qualification phases, the PQ implementation must also be documented in a report. This report may be part of the documentation for the operational qualification, or the process validation, or it may be handled separately within the documentation - there are no specific requirements. The PQ should, however, be recognisable as such in the documentation.
It must be possible on the basis of the report to clearly identify which materials may be processed on the facility and under what conditions.
As with the operational qualification, deviations from the anticipated results and their consequences (e. g. repeat control testing of the type and scope of supply connections and waste outputs) must be precisely noted during the performance qualification.
The transition to the process validation may only be made once the questions and problems arising in relation to the PQ have been clarified satisfactorily in the estimation of the persons responsible.
Tests that are carried out during the PQ may also be used for process validation provided that they offer an insight into the safety/suitability of the process. However, it is generally not possible completely to dispense with a process validation on the basis of the performance qualification results.
For the qualification of established (in-use) facilities, systems and equipment (according to Annex 15), sufficient data must be available in order to carry out a subsequent assessment and review of the various critical operational parameters and associated limits. The directions and records for calibration, cleaning, preventive maintenance, operating instructions and personnel training should also be documented.
The qualification of established facilities should comply with the life cycle model shown in figure 5. All qualification phases must be implemented on the basis of qualification protocols that have been approved beforehand. The DQ phase starts with a design check of the facility in its current state as described in chapter 3 Design Qualification (DQ) because established facilities must also be checked to determine whether they still meet the applicable minimum requirements.
Figure 5 Qualification of established facilities
In the IQ phase for established facilities, an inventory is made of the installed components and existing documents (cf. figure 3). Without a detailed and up-to-date account of the current condition of the facility (as-built), a check regarding suitability and subsequent change control will not be possible.
The check carried out during the OQ phase that follows the IQ phase to verify that the facility is functioning properly may be based either partially or completely on existing data obtained from an experience report. In an experience report, reliable data is compiled and evaluated for a defined period with the objective of checking whether the facility in question is functioning properly using a qualification protocol as the basis. For data sources (cf. figure 6), only evidence that can be verified as accurate and that is based on facts obtained through observation, measurement, investigation or other ascertainment methods may be used (cf. DIN ISO 8402:1995).
Figure 6 Data sources for an experience report
Data sources for an experience report
It must also be decided, on the basis of a risk analysis, which critical facility parameters must be covered by the experience report. For the compilation of suitable data for these parameters a production period must be selected during which, in general, no significant changes were made to the facility. The facility status during this period must also correspond with the current status of the facility to ensure transferability of the data evaluation to the actual status. The experience report should not be limited to a compilation of data, it should always be accompanied by a statistical evaluation (e. g. quality control chart analyses, machine capability studies).
When compiling the experience report if it is determined that the above requirements in relation to data sources cannot be met, or can only partially be achieved, additional practical tests for critical parameters may be carried out for which, due to the data situation, a retrospective evaluation is not permitted. A purely retrospective data evaluation is not permitted if the raw data that forms the basis of this evaluation is missing; if the data does not cover the current range of operational parameters; if major changes to the facility have been made; or if deviations or trends in the function of the facility have emerged during the period under observation and have not been clarified.
The qualification does not consist of one-off activities such as the introduction of a new manufacturing facility. The initial implementation should always be pursued as a continuous programme (cf. PIC/S document PI 006, Chapter 2.5.12).
Qualified facilities are subject to a range of influences that may endanger the qualification status:
Facilities should therefore be evaluated at specific intervals to ensure that they remain in a qualified state.
The documentation requirements for requalification are the same as those for initial qualification and therefore similar documents may be used in many cases (cf. PIC/S document PI 006, Chapter 6.6.3).
"Where no significant changes have been made to the validated status, a review with evidence that facilities, systems, equipment and processes meet the prescribed requirements fulfils the need for revalidation." (cf. Annex 15, No. 45 to EU GMP Guideline)
There is no general rule stating how often (i. e. the frequency at which) facilities should be requalified. It is impossible to state categorically when and how qualifications should be carried out as the size and complexity of production processes and facilities vary considerably (cf. PIC/S document PI 006, chapter 2.5.5). The specification of a suitable requalification deadline therefore clearly depends on the risk evaluation by the pharmaceutical manufacturer. The extent to which conclusions may be made regarding the occurrence of defects, their frequency and probability of detection depends on the type and scope of records that provide an insight into the function of the facility. In this regard, all manufacturers are at an advantage who have already introduced continuous monitoring of all critical facility functions (as is standard practice in other safety-relevant areas of industry). This check may also be carried out using quality control cards and machine capability studies (to determine CMK value).
For change projects where only one specific aspect has been modified, it is not absolutely necessary to requalify a facility from scratch. However, it is important to carefully assess the type of change in order to identify possible consequences and to establish the precise scope of the requalification.
Qualifications should document the suitability of facilities.
The head of production is responsible for the qualification of manufacturing facilities.
When transferring qualification work to third parties, the tasks and responsibilities must be defined in a contract.
Qualifications must be documented in the form of qualification protocols and reports.
The qualification must be implemented in stages: DQ, IQ, OQ and (if required) PQ. Precise instructions of the work involved at each stage must be given (qualification protocol) and the implementation of this work must be authorised.
The qualification of old facilities is feasible provided a detailed experience report can be compiled.
Facilities that have been successfully qualified must be released for routine production.
Facilities should be evaluated at specific intervals to determine either that they are still in a qualified state or that requalification should be carried out.


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Tag: Abdullah
Abbas Last Arab Leader on Trump's Call Schedule
President Donald Trump on Friday plans to call Palestinian Authority Chairman Mahmoud Abbas for the first time, according to the official White House schedule....
Jordan's King Abdullah: Threatening the World
The world must sense the coming storm in Jordan and recognize that Jordan's king is damaging his country thereby posing a threat to the region in order to buy himself more time on the throne,
Israeli Arab Immigrant Wins Gold Medal for Jordan
The Abu Gosh family immigrated to Jordan from the Israeli Arab village of Abu Gosh, located on the main highway to Jerusalem.
Analysis: Trump's Anti-Terror Plan Calls for Tough Immigrant Vetting, International Coalition...
There was absolutely no new policy idea in the Trump speech Monday night, but there was an implied promise to encourage all levels of law enforcement to be less restrained in pursuing their targets.
Jordanian Parliament Boycotts Israeli Delegation: "We Don't Recognize the Peace Treaty"
Parliament Speaker Atef Tarawneh announced that the Jordanian Parliament has refused to approve the attendance of an Israeli delegation at an international summit held in Jordan this week.
King Abdullah Zigzagging on Temple Mount CCTVs
The idea makes such good sense, one wonders how come they haven't thought about it before… but, of course, they have.
Arabs Planned to Explode Pipe Bombs at Jews on Temple Mount
Police have confirmed they found pipe bombs that could be filled with explosives at the Al-Aqsa mosque,
Security Minister: Outlaw Muslim Radicals from Temple Mount
An Al Aqsa NGO official responds: "The Temple Mount is not part of Israel." PA accuses Erdan of "racism."
King Abdullah of Saudi Arabia, Dead at 90. King Salman Succeeds.
King Abdullah bin Abdulaziz of Saudi Arabia has died at the age of 91. Crown Prince Salman succeeds the monarch.
Israeli Envoy: Jordan King Blasting Israel to Appease his Arab Allies
Israel's ambassador to Jordan suggested that King Abdullah's recent rants against Israel stems from pressure by Saudi Arabia, Qatar and Egypt.
As Israelis Mourn the Dead, Jordanians Glorify Killer
The very word "hero" was used by the Jordanian justice minister in joining the chorus calling for the release of a convicted terrorist.
Will the Arab Spring Reach Jordan?
Jordanian-Palestinian activist Mudar Zahran says King Abdullah is seeking to save Himself by colluding with Islamists, Iran and Assad
What is Really 'Broken' In Syria?
The conflict between the Sunni Muslim Brotherhood and its allies and the self-described Alawites is the rupture in "broken" Syria – and it is not new.
King Abdullah and Abbas: Jointly Prevent Judaization of Jerusalem
According to its peace treaty with Jordan, Israel recognizes Jordan's role as custodian of Muslim sites in Jerusalem, but that role is not to "prevent the Judaization of Jerusalem."


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•Eclectic Prog
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Studio Album, released in 1998 Songs / Tracks Listing 1. Rat Dance (4:30) Search PROMETHEAN Somber Regards lyrics Music tabs (tablatures)Search PROMETHEAN Somber Regards tabs Line-up / Musicians- Sami Lehtiniemi / Drums Avantgarde AV032 |
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Allowing for the inevitable disappointment, the overall sound is still intact, even if harder rock elements are fast encroaching on tracks like "Rat Dance" and "Spiderland", and they sound as depressed as Pink Floyd on "Blazah", while the strings that provided so much relief in every sense of the word have been abandoned. The flutes do remain, especially effective on the two highlights, the back to back brilliant folk rocker "Selfportrait" with its sad yet shape shifting and uplifting tune, and the mostly acoustic title cut, with an intensely tragic character succinctly explaining his plight as he closes:
"They say that I'm cold and I do plead guilty. But you cannot blame me you don't know what I've been through"
Again Promethean closes with the longest cut, and this one is better than the ultimate epic on the previous album. "Pennywhistle" starts off like one might expect given the title, with an almost jig like quality where even the vocals almost sound happy, before entering a plodding instrumental section that segues into hard rock nigh metal before closing out with the opening themes.
If only the sophomore jinx could be handled as well by everyone. "Somber Regards" is effectively a sad farewell for this short lived Finnish group, mixed in quality but with plenty of highlights for those with eclectic tastes.
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Buy this unique 999 pure 1 oz Athenian Owl silver coin, featuring a modern rendition of the Ancient Greek Tetradrachm as used 2500 years ago.
Ancient Greece is often referred to as the birthplace of Western culture and democracy, and is famous for its advancement of philosophy, science and mathematics. Athens also had state ownership of the silver mines at nearby Laurium, which was one of the main sources of revenue for the Athenian state. The tetradrachm functioned almost like an early reserve currency, used by both the friends and enemies of Athens as a common currency.
The reverse of this coin features an Athenian Owl standing on a branch, with a sprig of olive and a crescent moon just as on the ancient coin. Unlike the tetradrachm which had 17.2 grams of silver, this modern rendition is one full troy ounce, or 31.103 grams. The letters AOE stand for Alethia Orno Eternia which translates as Truth, Honour and Forever.
Add this homage to sound money to your collection today!
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me and many other players get annoyed when some c graders bowl at us.
not the bowlers but the ones there to fill in the numbers who bowl down the leg side more often than not, giving me no practise at all.
That is annoying, and at my club it seemed to be solely the domain of the batsmen. As a bowler, it was hard to get any batting practice at all cause you'd go in last and no-one could be bothered. Either that, or when you're in there they think they'll try to spend the whole afternoon taking your head off. They bought in a new system in the end where you batted in the order you turned up, but it still didn't stop guys from pissing off after they'd had their turn.
The only reason I didn't bowl to people in 3rd or 4th grade most of the time was because there was a bit of a difference in levels and if you hit one of the 4th graders and you're a 1st grade bowler you usually don't have too many excuses. I'd bowl in two nets to 1sts and 2nd graders and if a 3rd or 4th grader wanted me to bowl at them I would. Of course, you can slow down and bowl a few, but I was there to practice what I do too so 2 hours of slow doesn't really help.
R.I.P Craigos, you were a champion bloke. One of the best
R.I.P Fardin 'Bob' Qayyumi
Member of the Church of the Holy Glenn McGrath
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The internet was broken on Saturday as numerous people took to social networking sites talking about the decision of the legalization of same-sex marriages in the US. However, there were a few with whom this decision didn't set well, and one such individual ended up irking the normally chilled out Bollywood filmmaker Karan Johar.
In fact, a twitter user posted a rather snide comment hinting at Karan's sexuality saying, "#Rumors : @KaranJohar to get married soon in USA." Interestingly, Karan who is known to take such comments in his stride lashed out at the user rather vehemently saying, "It's so sad and disgusting when a major breakthrough movement is made into a mockery by some on Twitter!! Shame!!!"
As for the fact of the matter, while the US Supreme Court passed a judgment on Friday ruling that same-sex marriage is a legal right across the country, homosexuality in India still remains illegal after the Supreme Court upheld Section 377 of the Indian Penal Code in 2013.


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Here's what the critics have said about Children of Ash
"This is one of the very best vampire series that I've ever read: tonally comparable to Cronin's Passage trilogy, Hogan and del Toro's Strain trilogy, and Matheson's I am Legend. Utterly readable." -Paul Goat Allen
Buy Children of Ash now:
]]>Some of you might know that in 2016 I graduated with my MFA in Writing Popular Fiction from Seton Hill University. I got the degree, in part, because I wanted to teach writing. It's been a dream of mine for a long time to have a writers' workshop where I share what I know about the craft, and I've been laying groundwork for a while to make it a reality.
One of my big goals for 2017 is to host a writing retreat. Then, in December, I was approached by a company that sells USB drives for companies to use as swag. I realized it was the perfect sort of giveaway to hand out at my writing workshops. Luckily, I'd just had a logo created for my teaching business that I could put on them, too. This is what you call synchronicity, friends. I am now the owner of these really awesome flash drives.
Aren't they cute? If you can't tell, they're little wooden books! The logo is sort of hard to see, too, but in person they look amazing. Thanks to my stalwart marketing assistant, Chelsea Klepfer, for designing the logo!
Now I basically have to plan a writing workshop. I know it's a backward way to motivate myself, but that's pretty much how I roll. If you're interested in taking a workshop with me or attending a retreat, definitely sign up for my newsletter because I'll be posting information for singing up there. My goal right now is to have a retreat in the fall and possible also host an online class this year, as well. Stay tuned !
Also, a quick thanks to USB Memory Direct for the custom drives they sent me. They were a pleasure to work with, and I'll definitely be ordering more.
]]>As a special holiday treat, I've made the first story in my Meridian Six series free from Dec. 14-16!
"A masterful fusion of post-apocalyptic fiction, dark fantasy, and subtle social commentary, this is, simply put, the best self-published vampire story I have read in my 20 years of reviewing. And it's just the beginning of a series that has the potential to change the landscape of genre fiction." -Paul Goat Allen, Blue Ink Reviews
Enter: Dictation.
I read a couple of posts and a book by authors who swear by dictation as a method for drafting a novel. They pretty much all recommended Dragon for dictation, but a quick search told me the program is $300. I have text-to-speech (TTS) on my Mac (just open any document or program and fit the "function" key twice), and I can't imagine the Dragon software is 300X better. I did, however, download the free Dragon app for my phone for dictating on the fly.
Here's what I've been doing. While I'm out running errands or if an idea comes to me while I'm folding laundry, I pick up the phone, speak into the app and then email it to myself. Now, the resulting document is a mess. First, the app doesn't register punctation, so it's really a string of words without any formatting. But the beauty of this is that once I'm back at my computer, I take those raw words, add the punctuation, and flesh out the scene. In essence, the dictation draft, messy as it may be, allows me to not face a blank page.
We've all been there, right? We get a fresh cup of coffee, turn off the internet, pull up our word processing program of choice, and then stare at the blinking cursor of death. It's hypnotic, that cursor. It taunts and dares us to try to be brilliant. It's daunting, y'all.
But if you can come to a page that already has some raw material on it, it somehow feels more manageable. "I don't have to create anything from scratch, I just have to fix these words."
A few benefits of this method include:
You talk faster than you write, so you can get a lot of words down quickly.
Speaking your story might make it easier to access your authentic voice.
Because your goal is just to get ideas and words down, it's easier to ignore the internal editor.
Dictation might not be for everyone. It takes some getting used to to speak your story instead of type it. If it just doesn't work for you, there's another option. I have a new obsession for fountain pens. I have cheap ones and expensive ones (the cheap ones are actually my preference), and they make writing by hand a pleasure. In the same spirit of just getting things down, I like to sit down and write a quick scene on paper. Often it's just a page or two of dialogue. There's something freeing about putting it on paper. "I'm just jotting down some notes," I say. "There's nothing here that can't be changed."
Once I have a couple of pages, I either type the scene into Scrivener or I'll speak it using the TTS function on my Mac. Again, the goal here is just to get something on the page that I can go back and flesh out. The bonus is that it's easier for me to carry a pen and a notebook in my purse than to lug around my laptop. The benefits of this method are pretty similar to the dictation method, but you don't have to worry about messing with technology you've never used before or the pesky problem of dictation programs inaccuracies.
My point here is that sometimes we have to get creative and work smarter. There is no writing police force who will arrest you if you speak your story instead of type it. You don't have to sit in front of a computer for the work to count. Progress is more important that perfection, especially in the drafting phase.
If you're feeling stuck, try to speak your story. Or pull out your favorite pen and jot down your scene. You've not nothing to lose but your resistance.
Happy Writing!
]]>Today's Craft Thursday entry is from my Jaye's Office Hours vlog. James asked me how to avoid writing cliched stories, and this is my answer. Did you know I have lots of craft posts over on my Youtube channel? Subscribe today so you never miss a video!
]]>One of the interesting things you realize when you hang out with creative people is that most creatives are not one-dimensionally creative. For example, many of the writers and musicians and painters I know also love to cook. A painter I know loves to sew and a musician friend is also into photography.
I mention this on Craft Thursday because it's important for us all to remember that being creative is not a means to an end. Creativity is a way of life.
It's important to remember this because there will be times when you feel burned out from writing. Sometimes this burn out is simply resistance. Other times, it's your subconscious telling you it needs some time to replenish itself. Ironically, one of the best ways to refill your creative well is to be creative–just in a different way.
I was complaining to my husband the other day that every time I sit down to write, I hit a wall. I have about five books waiting to be written, but when I try to put words to paper I freeze up. Mr. Jaye reminded me that I've just come out of a pretty intense period of change. He suggested I take a break for a little bit, and give myself permission to do things for fun.
The truth is that at this point in my career, anything I write carries a lot of weight behind it. The weight of expectations, the weight of income, the weight of defining myself in my industry, etc. So I decided that instead of just retreating into Candy Crush or making myself crazy by investing too much energy in the election drama, I needed to be creative in a different way.
That's when I remembered how much I used to love to paint. It's been probably fifteen years since I've taken a painting class or done a project for fun, but that's okay. I'm not doing this to prove myself to anyone. I'm doing it to inspire myself to be creative. So out came my old portfolio and my old black tacklebox filled with tubes of paint, brushes, sketching pencils, and those marvelous gummy erasers. Something sort of magical happened when the scent of the supplies hit me. I got excited.
I went to the art store and bought a kit to paint a cheesy painting of a water mill next to a river. It's going to take me a long time because I'm an incredibly bad sketcher and the painting is pretty detailed. That's all right. It's fun to lose myself for an hour or two sketching tiny leaves and a water mill. That's call flow, my friends. Flow is where the magic happens.
The other great thing about this project is that its visual and tactile. Writing is such a cerebral practice. You're in your head so much that sometimes it's hard to find your way back out. With my painting, it's nice to get my hands dirty and see the picture coming together as I work.
Anyway, my point is that f you're finding yourself stuck, don't beat up your muse (or yourself). Try switching gears a little. You don't have to be good at your other creative pursuits. That's not the point. Being creative is about indulging your curiosity and your sense of play. You don't have to do "serious" art either. Try some subversive cross-stitch or try a new recipe for dinner or create a vision board using pictures you cut out of a magazine. Some people might call these projects silly, but those people do not understand how critical play is to the creative mind. So ignore the haters and go try something new. Before you know it, you'll find yourself itching to write again too. And the best part? Being creative is way more fun than beating yourself up for not always being a word machine.
Writing should be fun sometimes, remember? That's why you started doing it, right? Creative play helps you get back to that beginner's enthusiastic mind.
Question: What other forms of creativity do you do besides writing?
Sabina Kane fans will be especially excited to see Sabina, Adam and Mr. Giggles again. In the story "Ladies' Fight," which I co-wrote with Caitlin Kittredge, Sabina and the gang team up with Ava the hellhound and Leo the reaper to hunt down an enchanted scythe. The fur really flies when the hairless cat demon meets a hellhound.
Worlds collide when two different urban fantasy series meet in each of the ten electrifying stories in this collaborative project, featuring beloved characters such as Peter Octavian and Dahlia Lynley-Chivers, Joanne Walker and Harper Blaine, Joe Ledger and Special Agent Franks, Sabina Kane and Ava. Urban Allies melds the talents of some of the most high-profile authors in the genre today—many of whom are working together for the first time—to give readers a chance to see their favorite characters in an imaginative and fresh way.
Contributors Include:
Charlaine Harris and Christopher Golden
Carrie Vaughn and Diana Rowland
Jonathan Maberry and Larry Correia
Kelley Armstrong and Seanan Mcguire
Joseph Nassise and Sam Witt
Steven Savile And Craig Schaefer
David Wellington and Weston Ochse
Stephen Blackmoore and Jeff Somers
C. E. Murphy and Kat Richardson
Jaye Wells and Caitlin Kittredge
Here's what reviewers are saying about it:
Library Journal (Starred Review)
These ten shared stories bring together the work of 20 different authors. "Ladies' Fight" matches up Caitlin Kittredge's hellhound Ava and reaper Leo with Jaye Wells's Chosen, Sabina Kane, her partner Adam, and demon Giguhl as they search for the Grim Reaper's scythe. In "Tailed," Seanan McGuire's Verity Price hunts a cryptid poacher and discovers a werewolf with her kids and Kelley Armstrong's Elena, Kate, and Logan. More pairings of fan-favorite characters, including Peter Octavian and Dahlia Lynley-Chivers, and JoeLedger and Agent Franks, bring fresh outings and fun crossovers sure to delight many readers. Verdict This anthology highlights incredible authors and their best lead protagonists. Readers will devour these stories, which answer the question many fans pose: "What if these two characters met?"
RT Book Reviews – 4 ½ Stars and a Top Pick
Literary mashups are no easy feat, but thanks to some excellent pairings and the work of a group of wonderfully talented writers, this collection is enormously fun from beginning to end, particularly for series fans. The teamwork on display in these stories yields some fascinating results, providing authors and readers with a wonderfully imaginative way to explore and reimagine some beloved characters and settings and offering the chance to see what happens when those characters and worlds suddenly collide. Devotees of the featured series will feel right at home with most of these scenarios, but newcomers will have no trouble at all diving into each of these stories, and will no doubt come out with a new list of must-reads as a result.
Authors such as Kelley Armstrong, Charlaine Harris, Caitlin Kittredge, and Jonathan Maberry combine their distinctive talents in this unique collection, where 20 best-selling urban-fantasy authors teamed up on 10 original short stories featuring their series characters…"Pig Roast" is a fun, fast-paced read, while "The Lessons of Room 19" is both a creepy read and a smart commentary on the haunting nature of grief. "Blood for Blood" introduces Peter Octavian to Dahlia Lynley-Chivers, and their dangerous adventure will have readers flipping the pages. Once readers arrive at "Spite House," they will wonder how it is possible that Seattle PIs Harper Blaine and Joanne Walker have never met before. Most of the stories serve as a nice introduction to these individual series and will send readers unfamiliar with these characters back to library shelves to find the backlist. Recommended for fantasy collections.
Publishers Weekly
"An all-star roster of 20 urban fantasy authors headlines this collection of 10 crossover adventures, each of which sees two writers pitting their signature heroes against shared threats…Nassise (Midian Unmade) has assembled an admirable group of contributors who do a good if sometimes uneven job of blending both styles and toy boxes. The tales lean more toward the darker fantasy or horror end of the spectrum, making for an occasionally gory spectacle. Readers will undoubtedly get a kick out of seeing their favorite heroes solving cases together and will enjoy being introduced to new characters and settings. (Aug.)


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Dear Neighbors:
Like a typical Saturday morning, I was enjoying my front yard with my children, letting them play freely outside, and taking in the beauty of our mountain side community. Then a neighbor broke the news that AT&T plans to construct a 70-foot cell phone tower in the middle of our quiet residential community on property owned by the Crescenta Valley Water District.
Admittedly, at first I did not realize the gravity of what I had just heard. We were thrust into this battle suddenly and the more I researched and learned about cell phone towers, the more disturbed and concerned I became. Now the fear of AT&T prevailing in their plan keeps me up at night. Will I still be able to enjoy the scenery of our mountain community? Could I live in the shadow of a cell phone tower and feel safe? How much of a loss will I take if I am forced to sell my home?
This is a battle being waged city by city, town by town across the country. Some towns are successful in thwarting efforts to place these gigantic cell towers in their backyards; others are not so lucky. The efforts on the part of the residents, community leaders, local government, professional associations, and media outlets seem to make a difference in the outcome of the fight.
There are many reasons why placing these towers in the middle of residential communities is a bad idea. For one, studies have demonstrated, and local realtors can attest, that these cell towers drive down housing prices by as much as 20 percent. Depressed housing prices result in decreased property taxes and less money generated for our town. Furthermore, parents may move or think twice about buying homes in this community, resulting in decreased student enrollment and less school funding. In addition, the aesthetic appeal of our foothill community is rooted in the beautiful nature that surrounds us. A 70-foot cell phone tower disguised as a tree is an undeniable eyesore and is not in keeping with the natural beauty of our community. Cell phone towers are also uniquely susceptible to collapse and falling debris. Having lived in this area for many years, I am familiar with the heavy winds that come through our neighborhood. I personally had a gate completely blown off during a recent windstorm. Having a 70-foot metal structure in close proximity to our homes is frightening. Finally, cell phone towers are a source of fire danger that could devastate our residential community.
One more issue that is of concern to me, are the potential health risks that are associated with living near a cell phone tower. Some studies regarding the safety of cell phone towers show that it is not healthy to live or go to school in close proximity to cell phone towers, which emit electromagnetic radiation, twenty-four hours a day. While other studies may disagree, I believe that when it comes to our health and the health of our children, erring on the side of caution is the right thing to do. Current federal law prevents health concerns related to emission to be basis for the denial of one of these cell phone towers. Clearly, telecommunications companies have a strong lobbying presence in Washington; homeowners do not.
Please don't get me wrong — I understand the need for cell phone towers, but I also strongly believe that we need to protect homeowners in our community. I do not believe 70-foot towers (however they are disguised) in close proximity to residences are fair. I visited the site where AT&T intends on placing the tower recently. I was shocked to see how close the proposed tower would be to my neighbors' properties. If you could see what I saw, you would be outraged as well. Other cities, including Glendale, places strict requirements on telecommunications companies when they propose cell phone towers near residences and schools. This places the burden on the telecommunications companies to prove why that particular site is necessary and sets base-line rules to protect residents. We, the citizens of La Crescenta, need and should demand similar protections.
It is important to keep in mind that allowing this cell phone tower to go forward here sets a dangerous precedent that will open the door to similar tower installations in other residential neighborhoods across our town. Everyone in our community should be deeply concerned with this proposal. Please do not wait until a 70-foot cell phone tower arrives on your front door step or backyard. Get educated now and stake your position to protect your family, protect your property value, and protect your use and enjoyment of your property.
I urge all residents to email your comments and concerns regarding this proposed project to the Los Angeles County Planner, Michele Bush at firstname.lastname@example.com, on or before February 17, 2014. Please reference the case R2013-01031-(5), CUP201300055 AT&T and copy firstname.lastname@example.com, the CV Town Council Corresponding Secretary Cheryl Davis at email@example.com, and the Crescenta Valley Water District at email@example.com. If you would like to receive updated information and/or join us in our effort to defeat AT&T's proposal, please contact firstname.lastname@example.com to join our email list.
Please also make every effort to attend the following meetings where the community will be given the opportunity to express their concerns:
- Thursday, February 13, 6:30 PM: Crescenta Valley Town Council Land Use Meeting (La Crescenta Library Community Room, 2809 Foothill Blvd., enter through the door at the back of the building);
- Tuesday, February 18, 7:00 PM: Crescenta Valley Water District Board of Directors Meeting. (Crescenta Valley Water District Building, 2700 Foothill Blvd., La Crescenta);
- Thursday, February 20, 7:00 PM: Crescenta Valley Town Council Meeting (La Crescenta Library Community Room, 2809 Foothill Blvd., enter through the door at the back of the building); and
- Tuesday, March 4, 1:00 PM: Department of Regional Planning Hearing (Department of Regional Planning, 320 W. Temple St., Room 150, Los Angeles, CA 90012).
We have an uphill battle and we need the community's voices to be heard loud and clear: 70-foot cell phone towers do not belong in our backyards.
Karin Kim
Concerned Resident of La Crescenta


text:
Fillet Weld Polar Moment of Inertia Equations and Calculation
The following are equations to obtain the Polar Moment of Inertia for "J" welds.
Polar Moment of Inertia
Fillet "J" Weld [mm4, in4]
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text:
Posted on Wooden Ties...
#1 posted 12-08-2011 06:53 AM |
Looks ripe for Lazy Larry patterns ;-)) -- Bob in WW ~ "some old things are lovely, warm still with life ... of the forgotten men who made them." - D.H. Lawrence |
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Map of hotels near Flyers Skate Zone
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