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© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
The International Consortium on Innovation and Quality in Pharmaceutical Development (IQ) formed in 2010, and is an association of more than 25 pharmaceutical and biotechnology companies with a mission to advance science-based and scientifically driven standards and regulations for medicinal products worldwide. In the June 2012 issue of Pharmaceutical Technology, a paper written by the IQ Consortium's GMPs in Early Development Working Group described the desire and rationale for more clear and consolidated recommendations for GMPs in early development (Phase 1 through Phase 2a) (1). A consequence of the absence of clarity surrounding early phase GMP guidances has been varied interpretation and application of existing GMP guidances within different companies according to its own culture and risk tolerance. Internal debates often result in conservative "one-size-fits-all" interpretations that rely on International Conference on Harmonization (ICH) guidelines that are mostly relevant to commercial product development and do not distinguish differences in requirements between early development and later stage development (Phase 2b and beyond). A key driver of this working group (WG), therefore, has been to collectively define the minimum acceptable practices within the industry regarding GMP expectations in early development that allow for added flexibility, are consistent with existing guidance and statutes, and which assure product quality and patient safety (2–4).
The second paper in this series addressed recommendations for analytical method validation of both drug substances (DS) and drug products (DP) (5). In this third article of the series, the authors address the application of GMPs in early development as they pertain to drug-product manufacturing.
As noted previously in the introduction to the paper series, due to high attrition in early development, most companies try to minimize the resource required to advance compounds into human clinical trials by employing simple formulations and manufacturing processes (1). For example, drug substance filled in bottle, drug in capsule, or simple powder blends filled in capsule are frequently used. Even for more challenging molecules, for example, those with low aqueous solubility, prototype formulations designed to investigate bioavailability enhancement (e.g., amorphous solid dispersions, lipid-based drug delivery systems, nanosuspensions) are evaluated in as simple a manner as possible. For example, on-site preparation at the clinic site of an amorphous solid dispersion by weighing into a capsule, or by suspension in a suitable vehicle may be utilized instead of a finished tablet or capsule dosage form. Whatever approach to formulation/process is taken, there is a need for flexibility in manufacturing due to limited product and process understanding in early development.
Based on the collective industry experience of the members of this working group, the authors believe that pharmaceutical companies could be making better use of available guidances as they pertain to drug-product manufacturing in early development. This belief was reflected by the mixed responses to a survey of IQ member companies conducted in late 2011 (see Table I). Accordingly, in this article, the authors provide pragmatic recommendations related to GMP drug-product manufacturing focusing on those areas where it is believed there is opportunity for added clarity and flexibility, without added risk to product quality and patient safety.
Following a brief explanation of the role and importance of quality systems, the areas highlighted in this paper include facilities, equipment, materials (receipt and approval for use), and batch documentation. Not covered is cleaning verification/validation, as this is a topic that is addressed in detail in the industry (6). The scope of this position paper has purposely been limited to traditional small molecules that are formulated into solid oral dosage forms intended for US regulatory filings with the desire to build consistency across all worldwide regulatory regions. However, it is believed that the concepts presented can be easily adapted to other dosage forms and routes of administration. Although designed as an industry position, it is recognized that each company needs to evaluate these recommendations for drug-product manufacturing practices based on individual business needs and risk culture.
GMP quality system.In early development, relationships between material attributes, process parameters and product quality attributes are typically not well understood. It should be anticipated that even during GMP manufacture, there will likely be a need to deviate from the process conditions specified in a batch record. Quality systems should have the flexibility to allow these changes to be documented in batch records without formal prior approval from the Quality department. However, these changes should be reviewed by Quality after production, to assess the potential impact to product quality and patient safety. It is crucial to summarize and track process changes because much of this information will be used to develop process understanding and may be included in development history reports. In a similar manner, unplanned deviations from the written manufacturing procedures should be documented and justified, but may not need to be addressed in a formal corrective and preventive action (CAPA) system, because the process is changing continuously as part of the development process. Unplanned deviations that are likely to impact product quality and patient safety, such as cleaning failures, contaminations, and certain equipment failures must be investigated and corrective actions put in place to prevent recurrence.
Risk management in early development. To assist in the application of risk-based decision making in the development and manufacturing of drug product, the authors recommend that companies apply a scientific and risk-based approach, similar in principle to that of the ICH Q9 Quality Risk Management guideline (7). Annex I of the guideline describes various methods and tools that can be useful to determine the relative risks related to system risks, such as facility and people; organizations (including quality systems); process risks and product risks (safety and efficacy). There are many ways of identifying, qualifying, and mitigating operational and quality risks. Regardless of the methodology used, a documented strategy and good records of risk-based decisions are important in ensuring that the appropriate factors are considered for the protection of patients and product quality.
Regardless of the scale of manufacturing, the facility used for manufacturing clinical trial supplies must meet the basic GMP requirements as described in the regulations and guidance documents. Below are three scenarios for early development and the advantages of each as pertaining to early development. The first involves a pilot plant facility designed and equipped for routine GMP operations. The second scenario aims to establish a GMP area within a laboratory environment. The third example focuses on conducting GMP manufacturing or leveraging the practice of pharmacy in close proximity to the clinical site.
GMP facility for drug-product manufacture. The traditional approach in GMP drug-product manufacture is to use a dedicated facility (often called a pilot plant) for early phase clinical trials. Advantages of this approach include that the quality systems for the facility (i.e., maintenance, calibration, cleaning, change management, CAPA, and documentation) are well defined, and that training and other activities required for maintaining GMP compliance are centralized. Other drivers to use a pilot plant in early development may be the need for specialized equipment, or larger batch sizes in special situations.
GMP area within a laboratory setting. In some cases, it may be advantageous to establish a GMP area within a "laboratory setting" (i.e., a drug-development facility not dedicated to the production of clinical supplies) for the manufacture of drug product in early development. The rationale for this approach might be to avoid the significant investment in setting up a dedicated facility and to create simpler, more flexible systems that meet GMP requirements but are tailored for the specific activity envisioned. Examples where this approach might be considered include the need for special containment not available in the pilot-plant; the need to work with radioactive or hazardous materials, use of controlled substances and the production of "one-off manufactured" product used for proof of concept. The business rationale should be documented and approved by the manufacturing and Quality groups. As long as the appropriate GMP controls are maintained, especially as related to operator safety, cleaning, and prevention of cross-contamination, there is no compliance barrier to using "lab-type" facilities for the manufacturing of early phase clinical batches. Before GMP manufacturing is initiated, however, a risk assessment should be conducted and documented. Inclusion of representatives from Quality, analytical, clinical manufacturing, product development, and environmental health and safety would be prudent. When selecting/designing an early development clinical manufacturing facility, consideration should be made for the receipt, storage, dispensing, and movement of materials. The manufacturing processes in the nondedicated area must protect the product, patient, and the manufacturing operators.
Additionally, companies should consider what items are appropriate for the manufacture. For example, the use of a certified laminar flow hood may be a better choice for manufacturing than a fume hood, because the former is designed to prevent contamination of the product, protect the operator, and the laboratory environment. In addition, with the appropriate cleaning, a laminar flow hood can more easily be used for multiple products. Small scale/manual equipment or procedures may be the best approach because the space is likely to be limited. With a small batch size, the use of small scale or manual equipment/procedures will minimize yield loss. Additional measures to be assessed include appropriate gowning and operator personal protection devices, area and operator monitoring for potent or radiolabeled drug exposure, and so forth.
Documentation of the facility preparation, product manufacture, and the return of the facility to the previous state, if needed, is recommended. This documentation should describe the rationale for the manufacture in the nondedicated area, risk assessment, preparation of the area, cleaning procedures, and list of responsible persons. This documentation can reference existing procedures or standard operating procedures (SOPs) along with documents associated with the meetings and preparation for the manufacture of the batch. Batch records and cleaning records should be part of the documentation and should follow the company's data-retention policy.
Preparation at the clinical site. On-site preparation of formulations, sometimes referred to as "extemporaneous preparation" or "compounding," is not considered manufacturing, but is an effective method to prepare early clinical supplies using the local laws governing the practice of pharmacy. The processes used for on-site preparation can be as simple as preparing and diluting solutions or filling capsules with API to more complicated processes such as blending and compression of tablets. An IQ working group addressing current practices in extemporaneous preparation has conducted a survey to be communicated at a later date, which confirms that only a few companies have adopted practices to take advantage of more advanced formulation approaches at the clinic site (8). This is a missed opportunity, because on-site preparation of formulations has the potential to dramatically speed industry's ability to answer critical questions related to pharmacokinetic parameters, absolute or relative bioavailability, feasibility of extended release and bioavailability enhancement approaches for difficult to deliver molecules. Currently, each company must develop its own best practices to assure product quality and patient safety; often, these practices are based on compendial or professional association publications (9–11). The authors believe this topic warrants further discussion between the industry and regulatory authorities to determine when dose preparation at the clinical site is appropriate and the level of quality controls required. The results of such a discussion could help to increase the utilization of on-site preparation of clinical trial materials to facilitate quick answers to critical questions in early drug development and ultimately bring the best possible products to patients in the shortest time.
Equipment. Most equipment used to manufacture early GMP drug product is be managed under a qualification, preventive maintenance, and calibration program for the GMP facility. However, in early development, there may occasionally be a need to use equipment that is not part of such a program. Rather than performing a comprehensive qualification for a piece of equipment not expected to be frequently used, an organization may choose to qualify it for a single step or campaign. Documentation from an installation qualification/operational qualification (IQ/OQ) and or performance verification at the proposed operating condition is sufficient. For example, if solution preparation needs a mixer with a rotation speed of 75 rpm, then documentation in the batch record using a calibrated tachometer to verify that the mixer was operating at 75 rpm will suffice.
The use of dedicated or disposable equipment or product contact parts may be preferable to following standard cleaning procedures to ensure equipment is clean and acceptable for use. However, not all equipment or equipment parts are disposable or may have a substantial cost that makes disposal prohibitive. In that case, the product contact parts could be dedicated to a specific drug substance for use in drug product manufacture. Dedicating product contact parts to a compound may be costly and may be avoided in some cases by carefully considering product changeover and effective cleaning methods when purchasing equipment.
Another item to consider with respect to equipment, is that the more complicated the equipment is to run or maintain, the less desirable it might be for early GMP batches. In most cases, simple equipment is adequate and will uses less material and consume less total time for preparation, operation, and cleaning activities.
Buildings and facilities. GMPs under the 21 Code of Federal Regulations (CFR) Part 211.42 state that buildings or areas used in the receiving, storage, and handling of raw materials should be of suitable size, construction and location to allow for the proper cleaning, maintenance, and operation (7). The common theme for this section of CFR Parts 210 and 211 is the prevention of errors and contamination. In principle, the requirements for buildings and facilities used in early phase manufacturing are not significantly different than those for later phases or even commercial production. However, there are some areas that are unique to early clinical trial manufacturing.
Control of materials. The CFR regulations under Part 211.80 provide good direction with respect to lot identification, inventory, receipt, storage, and destruction of materials (7). The clear intent is to ensure patient safety by establishing controls that prevent errors or cross-contamination and ensure traceability of components from receipt through clinical use. In general, the requirements for the control of materials are identical across all phases of development, so it is important to consider these requirements when designing a GMP facility within a laboratory setting.
For example, all materials must be assigned a unique lot number and have proper labeling. An inventory system must provide for tracking each lot of each component with a record for each use. Upon receipt, each lot should be visually examined for appropriate labeling and for evidence of tampering or contamination. Materials should be placed into quarantine or in the approved area or reject area with proper labeling to identify the material and prevent mix-ups with other materials in the storage area. Provision should be made for materials with special storage requirements (e.g., refrigeration, high security). The storage labeling should match the actual conditions that the material is being stored and should include expiry/retest dates for approved materials. Although such labeling is inconvenient for new materials where the expiration or retest date may change as more information is known, this enables personnel to be able to determine quickly whether a particular lot of a material is nearing or exceeding the expiration or retest date. General expiry/retest dates for common materials should be based on manufacturer's recommendation or the literature.
Finally, there are clear regulatory and environmental requirements for the destruction of expired or rejected materials. It is important to observe regional and international requirements regarding the use of animal sourced materials (12). It is recommended to use materials that are not animal sourced and that there be available certification by the raw material manufacturers that they contain no animal sourced materials. If animal sourced raw materials must be used, then certifications by the raw material manufacturers that they either originate from certified and approved (by regulatory bodies) sources for use in human pharmaceuticals, or that the material has been tested to the level required for acceptance by regulatory agencies (following US, EU, or Japanese guidelines, as applicable) is required.
Specifications. It is a GMP requirement that all raw materials for the manufacture of drug product have appropriate specifications to ensure quality. The compendial requirements should be used for setting specifications provided the material is listed in at least one pharmaceutical compendium (e.g., US, European, and Japanese Pharmacopeias). It is important that the use of materials meeting the requirements of a single compendium is acceptable for use in early phase clinical studies conducted in the US, Europe, and Japan. For example, a material that meets USP criteria and is used in the manufacture of a drug product should be acceptable for use in early clinical studies in the European Union. In the absence of a pharmaceutical compendium monograph, the vendor specification and/or alternative compendial specifications such as USP's Food Chemical Codex should guide specification setting. In any case, the sponsor is responsible for the establishment of appropriate specifications. Therefore, it is the authors' position that good practice is to have at least a basic understanding of the manufacture, chemistry, and toxicology of the materials to guide appropriate specification setting.
Material testing and evaluation. The minimum testing required for incoming materials is visual inspection and identification. However, as mentioned above, the appropriate tests should be determined for the material based on the knowledge of the manufacture, chemistry, and toxicology. If the vendor is qualified, then the certificate of analysis may be acceptable in conjunction with the visual inspection and identification testing (see "Vendor Qualification" section below).
Approval for use. Ideally, manufacture of a bulk drug product should begin with approved material specifications and with materials that are fully tested and released. However, there are circumstances where it may not be feasible to start manufacture with approved specifications and fully tested and released materials, including API. Manufacturing prior to final release (sometimes called manufacturing "at risk") may be acceptable, however, because the quality system ensures that all specifications are approved, test results are within specifications, and all relevant documents are in place before the product is released for administration to humans. The "risk" must lie fully with the manufacturer and not with the patient.
Vendor qualification. Vendors supplying excipients, raw materials, or API must be qualified by the sponsor. Appropriate qualification should depend on the stage of development and an internal risk assessment. For, example if a vendor has a history of supplying the pharmaceutical industry and the material is to be used in early development, a paper assessment (e.g., a questionnaire) should be sufficient. If a supplier does not have a history of supplying the pharmaceutical industry, a risk assessment should be performed and depending on the outcome a site audit may be required prior to accepting material for use.
Ideally, vendors should be qualified prior to using raw materials for manufacture. However, it is acceptable for qualification to proceed in parallel as long as documentation/risk assessments are available prior to product release and as in the previous section all risk lies with the manufacturer and not the patient.
Batch record documentation preparation. Manufacturing documentation is a basic requirement for all phases of clinical development. 21 CFR Parts 211.186 and 211.188 describe master production and batch production records, respectively (7). The stated purpose of the master production record is to "assure uniformity from batch to batch." Although the record assurance is important for a commercial validated manufacturing process, it does not necessarily apply to clinical-development batches. Material properties, manufacturing scale, and quality target product profile frequently change from batch to batch. Therefore, batch production records are the appropriate documentation for clinical trial supplies. Batch production records for Phase 1 materials should minimally include:
These minimum requirements are consistent with the FDA Guidance for Industry: cGMP for Early Phase Investigational Drugs, which requires a record of manufacturing that details the materials, equipment, procedures used and any problems encountered during manufacturing (2). The records should allow for the replication of the process. On this basis, there is flexibility in the manner for which documentation of batch activities can occur, provided that the documentation allows for the post execution review by the quality unit and for the retention of these records.
Batch documentation approvals. Review and approval of executed batch records by the Quality unit is required per 21 CFR Part 211.192 (7). This review and approval is required for all stages of clinical manufacturing. Pre-approvals of batch records should be governed by internal procedures as there is no requirement in CFR 21 that the Quality unit pre-approves the batch record (though this is highly recommended in order to minimize the chance of errors). Indeed, Table I shows that pre-approval of batch records by the Quality Unit is practiced by all 10 companies that participated in the IQ Consortium's drug-product manufacturing survey related to early development. Batch records must be retained for at least 1 year after the expiration of the batch according to CFR Part 211.180, but many companies keep their GMP records archived for longer terms.
Room clearance. 21 CFR Part 211.130 requires inspection of packaging and labeling facilities immediately before use to ensure that all drug products from previous operations have been removed. This inspection should be documented and can be performed by any qualified individual.
Although line clearance for bulk manufacture is not specifically mentioned in the CFR, it is expected that a room clearance be performed. At a minimum, this clearance should be performed prior to the initiation of a new batch (i.e., prior to batch materials entering a processing room).
Hold time. During the early stages of development, final dosage form release testing confirms product quality and support establishment of hold times later in the clinical development. There is no requirement to establish hold times for work in process in early development. Specific formulation and stability experience, which is usually limited at this stage of development, should be leveraged to assess any substantial variations from expected batch processing times. The data gathered from these batches and subsequent development can be used to help establish hold times for future batches. (Exceptions to this approach may include solution or suspension preparations used in solid dosage form manufacturing, where procedures typically govern allowable hold times to ensure the absence of microbial contamination in the final product.)
Change control. Changes to raw materials, processes, and products during early development are inevitable. It is not required that these changes be controlled by a central system but rather may be appropriately documented in technical reports and manufacturing batch records. Any changes in manufacturing process from a previous batch should be captured as part of the batch record documentation and communicated to affected areas. The rationale for these changes should also be documented as this serves as a source for development history reports and for updating regulatory filings. The authors recommend that those changes that could affect a regulatory filing be captured in a formal system.
Process changes. Process parameters should be recorded but do not need to be predetermined because processes may not be fixed or established in early development. Given the limited API availability in early development, a clinical batch is often the first time a product is manufactured at a particular scale or using a particular process train. Therefore, process changes should be expected. Process trains and operating parameters must be documented in the batch record but changes should not trigger an exception report or CAPA. Changes should be documented as an operational note or modification to the batch record in real time. Such changes driven by technical observations should not require prior approval by the Quality unit, but should have the appropriate scientific justification (via formulator/scientist) or the appropriate flexibility built into the batch record to allow for the changes. This documentation should be available for Quality review prior to product disposition.
Calculation of yield. Actual yields should be calculated for major processing steps to further process understanding and enable optimization of processes. Expected yield tolerances are not always applicable to early development manufacture. At this stage of early development, when formulation and process knowledge is extremely limited, there may be no technical basis for setting yield tolerances and, therefore, this yield may not be an indicator of the quality of the final product.
In-process controls and R&D sampling. In-process tests and controls should follow basic requirements of GMPS to document consistency of the batch. For capsule products, these requirements may include capsule weights and physical inspection. For tablet products, compression force or tablet hardness and weights should be monitored together with appearance. R&D sampling, defined as samples taken for purposes of furthering process understanding but not utilized for batch disposition decisions, is a normal part of all phases of clinical manufacturing. In early development manufacturing, a sampling plan is required for in-process control tests, but not for R&D samples. However, for the purpose of material accountability, R&D sampling should be documented as part of batch execution. For these samples, testing results may be managed separately, and are not required to be included in regulatory documentation.
Organizations involved in manufacture of Phase 1 and 2a clinical supplies should recognize that process understanding is very limited in early development. Quality systems must be robust enough to ensure patient safety, but should also be flexible enough to accommodate accelerated timelines and process changes in real time. The special needs of small scale GMP manufacturing should also be considered when designing facilities, purchasing equipment, and selecting the type of dosage forms to use in early clinical studies. Companies are encouraged to apply quality risk management principles to support these risk-based decisions.
The authors also believe that underutilized approaches exist (e.g., on-site preparation of more complex dosage forms) for quickly and efficiently answering formulation related questions about bioavailability, pharmacokinetics, and target release rates for controlled-release formulations. The potential benefits and risks of these approaches warrant further discussion. Finally, documentation of manufacturing operations should be risk-based. Manufacturing instructions in early development should not be overly prescriptive as to restrict process changes or discourage sampling for further process understanding. Changes should be expected, and able to be quickly reviewed and approved by the Quality department, or a qualified delegate.
To further stimulate discussions on these approaches within the industry and with worldwide health authorities, the IQ Consortium's GMPs in Early Development Working Group is planning on conducting a workshop in the near future to promote robust debate and discussion on these recommended approaches to GMPs in early development. The group strongly believes that such dialogue will improve alignment between development, quality assurance, and chemistry/manufacturing/controls (CMC) regulatory groups within the pharmaceutical industry. In addition, agreement between the industry and drug regulatory authorities regarding acceptable approaches to applying GMPs in early phases of drug development would allow for a more nimble and flexible approach in early development, while still providing appropriate controls to ensure patient safety.
Richard Creekmore is in pharmaceutical development at AstraZeneca (Wilmington, DE); Eleni Dokou is in pharmaceutical development at Vertex Pharmaceuticals (Cambridge, MA); Amnon Eylath is in quality at ARIAD Pharmaceuticals (Cambridge, MA); Dennis Joiner is in pharmaceutical sciences and clinical supply at Merck (Summit, NJ); Michael Lovdahl is in pharmaceutical sciences at Pfizer (Groton, CT); Jackson Pellett is in small molecule pharmaceutical sciences at Genentech (South San Francisco, CA); and Eric Schmitt and John W. Skoug* are in drug product development at Abbott Laboratories (Abbott Park, IL).
*To whom all correspondence should be addressed.
1. A. Eylath et al., Pharm. Technol. 36 (6) 54–58 (2012).
2. FDA, Guidance for Industry: CGMP for Phase 1 Investigational Drugs (Rockville, MD, July 2008).
3. FDA, "Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials," Fed. Reg. 73 (136), 40453–63 (2008).
4. EU, Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use, Annex 13: Investigational Medicinal Products (Feb. 2010).
5. D. Chambers, Pharm. Technol. 36 (7) 76–84 (2012).
6. D.A. LeBlanc, in "Validated Cleaning Technologies for Pharmaceutical Manufacturing," (Interpharm/CRC, Washington, DC, 2000).
7. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC).
8. Personal communication with Mike Kress, Leader, IQ Consortium Drug Product Working Group on Extemporaneous Formulations (May 2012).
9. USP 35–NF 30 General Chapter <795> Pharmaceutical Compounding-Nonsterile Preparation, 344–350.
10. USP 35–NF 30 General Chapter <797> Pharmaceutical Compounding-Sterile Preparations, 350–387.
11. L.V. Allen, The Art, Science and Technology of Pharmaceutical Compounding (American Pharmacists Association, 2008).
12. See, for example: the USP Excipient Supplier Qualification Program, Section 10 (V. 1.1, Sept. 2008), and references therein, for specific guidance.
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West Fork Trail - Oak Creek Canyon, Photo Gallery, Sedona: Red Rock - Secret Mountain Wilderness, Arizona
West Fork Trail - Oak Creek Canyon
Sedona: Red Rock - Secret Mountain Wilderness
The West Fork Trail begins at the Call O' The Canyon Trailhead, 10.4 miles north of Highway 179 on 89A. This famed trail follows the West Fork of Oak Creek 3.2 miles through Oak Creek Canyon to its maintained terminus, where hikers may either turnaround or continue upstream through ankle - chest high water.
|Related Trails:
|West Fork Trail
The West Fork Trail crosses Oak Creek over a dozen times
Ferns blanket the forest dark, damp forest floor
Views of the canyon walls are limited under the tall canopy
Beyond 3.2 miles the unmaintained trails enters the creek through narrow slots
Despite Oak Creek Canyon's cluttered appearance, travel upstream is fairly obstacle free
A rare Yellow Columbine along the West Fork Trail
Active components in horsetail have antimicrobial, antiseptic, and anti-inflammatory qualities
A heron scans the creek for trout one mile upstream of the maintained trail
Hikers will encounter deep water just beyond the maintained trail; once through, the creek is easily walked
Fir is prevalent in the canyon's higher elevations
The West Fork Trail runs along the outer canyon wall before dropping into the creek
Oak Creek has carved elongated grottos all along its path
Lupine is ubiquitous on the forest floor
Frequent stream crossings on the West Fork Trail
A leafy forest floor and canopy yield brilliant autumn colors

subset: commoncrawl


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Public Policy (MPP)
Please visit the program page to learn about curriculum, faculty, careers, and more! You may also be interested in seeing our course descriptions. To request more information about this degree, please fill out our form. Questions? Contact admissions via email or at 617-521-2915.
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Admission requires a baccalaureate degree from an accredited college or university and a strong undergraduate record. Additionally, evidence of exposure to U.S. politics and statistics is preferred. The applicant for admission must submit official transcripts of all undergraduate and previous graduate coursework, a statement of purpose, GRE scores, an academic or policy-based writing sample, and two recommendations (academic preferred). An interview is optional. Students are admitted to the MPP program in the fall semester.
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Successful applicants to the Master in Public Policy (MPP) program are required to complete college-level courses in statistics and microeconomics with a minimum grade of "B" in each. Applicants who are offered admission to the MPP program without having completed one or both of the required courses will be asked to provide evidence of successful completion of the relevant courses, including the grade(s) received, within the first year of study in the program. Admitted students who seek to fulfill the coursework requirements may enroll in relevant courses at Simmons or at any accredited college or university. Please contact the Office of Graduate Studies Admission at [email protected] or 617-521-2915 with any questions about fulfilling these requirements.
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Official course-by-course evaluations are required for all transcripts from universities outside the U.S. or Canada. Additionally, all transcripts that are in a language other than English must be officially translated. Only evaluations and translations from authorized organizations are accepted. The preferred provider of transcript evaluations at Simmons is World Education Services (WES):
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Disney is getting desperate. And weird.
After seeing visitor spending plunge in the past few months (helloooo, recession), Disney has decided that nothing is more inviting to little children than a life-sized, fully-functioning, ROBOTIC version of Mr. Change himself.
Disney animators, sculptors, and engineers have spent the past eight months analyzing Obama's appearance, speech and mannerisms. Their hard work has resulted in a robot Obama who "purses its lips to pronounce its b's and p's in a way frighteningly evocative of the real one, and raises its hands, open-palmed, while shrugging its shoulders, in a way that can only be described as Obamaesque," reports the New York Times.
Robobama has now been formally introduced to the public this weekend at Walt Disney World in Orlando, where he will (correctly) recite the oath of office and other selected speeches. The occasion will also mark the reopening of the Hall of Presidents, which has been undergoing its first facelift (ha!) since the 1970s.
And yes, the past 43 presidents will also attend the unveiling, albeit in robot form.
"Young children watch this, and you want them to feel a sense of identification with the president," said presidential historian Doris Kearns Goodwin.
A sense of identification? What about a sense of sheer terror? The only thing that would have frightened us more would have been a visit from Santa declaring that he was taking back all the presents he'd ever given us.
So if you and the kiddies head to Disney World this summer and seek a little scare, skip the lines at The Haunted Mansion and head to the inauguration of Robobama. That'll surely do the trick.


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Barack Obama is not, in any meaningful way, a Christian and I am not sure he needs to continue the charade. With no more elections for him, he might as well come out as the atheist/agnostic that he is.1 He took his first step in doing so yesterday in a speech reeking with contempt for faith in general and Christianity in particular.
Saying that violent acts are not representative of Islam, the President then attacked Christians for the Crusades (started as a response to Islamic invasion), the Inquisition (a Catholic thing, not us Protestants), slavery (abolished thanks to Christians), and Jim Crow (Dr. King also had a "Reverend" in front of his name).
Despite the interpretations and defenses of the President on what he meant, he gave away the game with a bit of the speech not given nearly as much play in the media. From the transcript:
I believe that the starting point of faith is some doubt — not being so full of yourself and so confident that you are right and that God speaks only to us, and doesn't speak to others, that God only cares about us and doesn't care about others, that somehow we alone are in possession of the truth.
Christ said, "I am the way, and the truth, and the life; no one comes to the Father but through Me." (John 14:6) Christ himself is truth. When we possess Christ, we possess truth. The President is a moral relativist. It was clear in his whole speech. He cannot condemn and attack ISIS as he should because in his mind what is truth? Truth is a nebulous concept with our post-modern President. With truth a nebulous concept, right and wrong are too.
We know God cares about everyone. We know Christ came to die for sinners. But Christians know Christ is truth itself. To have truth, we must have Christ. To suggest that everyone can have some version of God and some version of truth is worldly babbling, not Christianity.
The President followed up those words with these:
And so, as people of faith, we are summoned to push back against those who try to distort our religion — any religion — for their own nihilistic ends.
I agree.
So I wish the President would stop professing himself to be a Christian if he is not going to proclaim Christ as truth and the only way to salvation. The "all paths" nonsense and moral equivalence might fit in with the present age, but the present age does not really fit with Christ.
And as for doubts on whether I'm right, "the starting point of faith is some doubt" in my ability to save myself, not in whether I'm right. I know I'm a sinner. I know I cannot save myself. I have no doubt that Christ is the only way. It's not that I'm right, but that Christ is right. So, Mr. President, get off your own high horse.
1. No, despite what some think, Barack Obama is not a closet Muslim. Islam teaches that "there is no god but God, Mohammed is the messenger of God." Obama's name is neither Allah nor Mohammed. Therefore, there is no room for him to presume himself a god. So, Obama with faith only in himself, must be an atheist/agnostic.↩


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Hazelnut Milk Chocolate Bar is made from premium ingredients and stylishly presented in sustainable packaging.
Contains: nuts
Photos for reference only
To ensure your order arrives in perfect condition, each shipment is handled personally and with the utmost care.
Currently, we only deliver within Hong Kong SAR (excluding Outlying Islands, Lantau Island and remote areas).
Should you wish to deliver your order to multiple locations, please place separate orders for each delivery location.
Delivery charges are based on location:
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Complimentary delivery is offered for all orders of HK$2,500 and above.
Delivery of Gift Cards (including Experiences) are offered at a flat rate via Standard Shipping (2-3 days):
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Complimentary delivery is offered for all orders of HK$2,500 and above.
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Prior to your delivery, the delivery agent will telephone the number provided at the time of order to confirm the expected delivery time.
Unfortunately, we are unable to accept requests for deliveries at specific times.
Deliveries will be suspended if a typhoon signal No.8 or above is hoisted or a black rainstorm warning is in effect. In this event, we will contact you by phone or email to offer Hotel Collection (if you wish to maintain the same date) or an alternative delivery date.
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To collect an order, please visit Butterfly Patisserie located at Level 2 of Rosewood Hong Kong, adjacent to the Hotel Lobby.
Hotel Collection is available 12 noon to 8 pm, every day. You may select your desired collection date during checkout.
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Big summer continues for Hawks' Bickell
Nobody needs to remind Blackhawks winger Bryan Bickell how fortunate he has been the last few months.
Bickell parlayed a huge playoff performance in which he scored 9 goals and 17 points into a four-year, $16 million contract as an unrestricted free agent and now is considered one of the Stanley Cup champs' core players.
"It's been an amazing year," Bickell admitted. "From the season we had to winning the Cup to getting the extension to getting married. It's going to be a year to remember. It's been unbelievable. It still hasn't sunk in and we're almost halfway through the summer."
With a big contract comes bigger expectations, and Bickell is ready to deal with them. He is going to be expected to play every night like he did in the playoffs and be a top power forward with a physical edge and deft scoring touch.
Bickell likely will start the season where he finished it, playing on the top line with Jonathan Toews and Patrick Kane.
"There is definitely going to be pressure," Bickell said. "Throughout my career there have been some ups and downs in my consistency level, but last year was a big steppingstone for me to know what I need to bring every day to be at the top of my game.
"I feel coming into next year I need to play the same way. Confidence goes a long way. My confidence level right now is pretty high, and I need to bring that in to the next season and hopefully run with it. There are going to be ups and downs, but just knowing I can do it helps and hopefully I will."
Bickell played the entire final series against Boston with a torn tendon in his right thumb that ultimately required surgery.
"I got slashed in one (postseason) series and there was swelling and a cyst," Bickell said. "It was blocking blood flow and my thumb (tendon) was disintegrating, but I could play and I was happy. Then I was picking up my hockey bag and it just popped. (Trainer Mike) Gapski was right there and said, 'Uh oh, this is not good.' I couldn't move my thumb. I'm just recovering from surgery now. They had to take a tendon out of my finger and put it in my thumb."
Bickell loves to fish and admits having a cast on his thumb affected his fishing.
So has planning for his wedding, which will take place on Saturday.
"It has affected my fishing," Bickell said of his injury. "This wedding has been affecting my fishing too, but it's a good thing. There's going to be a lot of fishing, but this wedding is more important."
Bickell expects to be ready for the start of the regular season on Oct. 1 against Washington.
"Coming into the regular season, I'm going to be healthy," he said. "The most important thing is to be ready and be in the best shape possible."
Defending the Cup will be the next challenge facing the Hawks. No team has won back-to-back Stanley Cups since Detroit in 1997-98.
"We had some fortunate bounces go our way, but next year we just have to have the same mindset we did last year," Bickell said. "If we do that we have as good a chance as anybody."
• Follow Tim's hockey reports on Twitter @TimSassone and check out his Between the Circles blog at dailyherald.com.


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Rule #1 - Be Patient - Rule #2 - Don't ask when, if you don't contribute - Rule #3 - You have coding skills - LinuxMCE's small brother is available: http://www.agocontrol.com
dont the pad have i charger cable that you can just put in the mold?BR Daniel
The wall-wort plug I am housing inside the cradle is other than the PC standard 110-120V line plug, exactly the same as the OEM charger. 12v 3.5A. Something I am wondering now is if the cradle takes a higher Amp power supply?
I *believe* the charger charges the pad and the usb ports on the cradle are then powered from the pad, not the charger directly.
What portion(s) of a cradle would you like pics of?
There is a small cap between +'ve and gnd. A few more caps around the usb connectors.
The caps will be important, as those are for DC power conditioning and noise suppression, so Armor Gnome will need to match those values in his build. You could always post a pic of the parts if they're surface mount, and we could figure out the values for him.
I have used USB pins on mobos straight to the USB and I have pulled them from cases where the mobo leads went to a board with caps and diodes before going to the USB housing. Both have worked so I wasn't overly concerned with that side of it. On the iPhone USB hardwired dock I need to power up the WebDT with the orbiter running and see if the detection of USB storage causes any problems. I have no reason to suspect it would but its an easy test to see how the iPhone is handled if present at startup, when coming out of suspend and detected while running.


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The Slavic Department teaches the languages, literatures, and cultures of the Slavic nations. The curriculum provides the language training prerequisite to specialization in a variety of careers (e.g., government, diplomacy, international trade, teaching), and offers an enriching cultural and linguistic background to non-majors, especially those interested in the ethnic heritage of the Slavic peoples.
Do you need to fulfill some requirements?
Check out the courses in the Slavic Department!
The Department of Slavic Languages & Literatures can help you with your general requirements! We regularly offer courses that meet general requirements, and many of our courses fulfill multiple requirements. Our classes could help to round-out your schedule while broadening your horizons! Contact us at www.lsa.umich.edu/slavic or email@example.com.
Students with high school training in Russian are required to take both the reading and listening (CEEB) Russian tests to evaluate their language proficiency. The results of the placement test determine the proper placement. The Slavic Department has final authority to determine the most appropriate course level. Heritage students (students partially raised in a Slavic-speaking environment) are required to contact the Slavic Department prior to enrolling in any language classes.


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Between 2012 and 2014 we posted a number of articles on contemporary affairs without giving them volume and issue numbers or dates. Often the date can be determined from internal evidence in the article, but sometimes not. We have decided retrospectively to list all of them as Volume 12 Number 30 with a date of 2012 with the understanding that all were published between 2012 and 2014.
Paik Nak-chung
Just one week before the recent North Korean announcement of a forthcoming satellite launch, which was met by a chorus of denunciation around the world, a non-governmental "Six Party" conference gathered on March 7 to 9 at Millennium UN Plaza Hotel, New York City, under the name of the 2012 New York Conference on Peace and Cooperation in Northeast Asia. Its co-sponsors were the Friedrich Ebert Stiftung, the Maxwell School of Syracuse University, the Center for Peace and Public Integrity at Hanshin University, the National Association of Korean Americans, and the Pacific Century Institute.
The following article is a slightly revised version of a paper prepared for the opening Session of the conference devoted to a presentation by one speaker each from the participating countries (US, South Korea, Japan, Russia, China, and North Korea). Professor Paik here adds a postscript, dated March 28, on the significance of the New York meeting in light of subsequent
Paik Nak-chung, emeritus professor of Seoul National University and a prominent scholar, author, critic and activist, is one of Korea's most incisive contemporary public intellectuals. His latest book in English is The Division System in Crisis: Essays on Contemporary Korea, University of California Press, 2011.
It is a rare privilege to present 'a vision statement' along with speakers from other Six-Party Talks countries. I hasten to add, however, that I have neither the authority nor competence, nor indeed the inclination, to speak for the government of the Republic of Korea. Instead, I shall try to speak for like-minded people in the civilian sector of my country, while staking out a claim not fully shared even among those people. For I believe South Korea's civil society constitutes, or at least is in the process of constituting itself, as the (uninvited) 'seventh party' in the Six-Party Talks. I shall come back later and explain what I mean.
The Korean Peninsula occupies a pivotal place in Northeast Asia not only geographically but also in the geopolitical dimension of regional peace and security. The existence of Six-Party Talks with its focus on "peace and stability on the Korean Peninsula" (in the words of the September 19 Joint Statement of 2005) bears witness to this fact. The immediate focus of the Talks is on denuclearization of the Peninsula, but ever since the first North Korean nuclear crisis of 1994 it has become increasingly evident that the problem of North Korea's nuclear armament cannot be resolved in isolation from numerous related issues. The 2005 Joint Statement finally turned this recognition into an officially shared perception—or at least into an officially agreed verbal expression.
True, there are other important documents: bilateral high-level agreements between the DPRK and the United States (October 2000) and between the DPRK and Japan (September 2002), not to mention the June 15 Joint Declaration of 2000 and the October 4 Summit Declaration of 2007 between the two Koreas. But as the first multilateral accord regarding peace, cooperation and security of the region, and more far-reaching than anything since then, the September 19 Joint Statement remains the grounding document for any future efforts. Both its stated goals of denuclearization, normalized diplomatic relations, economic cooperation, and a permanent peace regime in Korea, (articles 1-4), and its prescribed method of implementing "in a phased manner in line with the principle of 'commitment for commitment, action for action'" (article 5) have set down the guidelines for any future scheme of the region's peace and security.
But in one crucial respect it has become outdated: North Korea since that time has conducted nuclear tests (in 2006 and again in 2009) and acquired a nuclear arsenal, a development which the Joint Statement had been intended to forestall. This has made the problem much more complicated and difficult to resolve, not least by creating so much distrust and bad blood among the concerned parties. But then, one may reflect that the problem in all likelihood was always a good deal more complex than any of the six parties ever realized.
Take the nuclear issue. The September 2005 agreement would provide North Korea, in return for its denuclearization, normalization of DPRK-US and DPRK-Japan relations, a peace treaty (through negotiations among the four directly related parties) to replace the 1953 Armistice regime, and a greatly expanded economic and energy assistance and cooperation. It is doubtful, however, that Pyongyang's paramount concern for its security would be satisfied by these measures, for, unlike China and Vietnam when they embarked on the course of 'reform and opening', North Korea would still be faced with the threat of the presence of a far wealthier South, a presence that could become all the more threatening and even destabilizing in a period of expanded contact and collaboration. On the other hand, neither diplomatic normalization nor substantial economic assistance would be forthcoming without progress toward abolition of those very nuclear weapons that are expressions of North Korea's sense of insecurity. So here we have a veritable vicious circle—or at least a very vexing conundrum.
This is not to say that we should throw up our hands and resign ourselves to the status quo, hoping (against hope) that somehow things will not get worse over time, that Pyongyang, too, will accept a status quo that is already intolerable enough to them. If the rest of us find it a little less so at the moment, they will surely do everything to shake our complacency. We thus have no choice except to start again with the agreements we already have, proceeding "in a phased manner in line with the principle of 'commitment for commitment, action for action'," but also keeping the big picture in sight and searching for a more innovative resolution of the conundrum.
As a matter of fact, a highly innovative formula for inter-Korean relations was discovered and agreed upon in the 2000 summit meeting of Kim Dae-Jung and Kim Jong Il. Article 2 of the June 15 Joint Declaration called for a phased reunification process with its first stage closer to a confederation than to a federation, (as virtually acknowledged by Pyongyang when it used the phrase 'low-stage federation' as an alternative to the South's proposal of a confederation or, to be more exact, a union of states). I happen to believe that for the moment it is more realistic to work toward a 'low-stage confederation'—a union or association in many respects looser than the European Union. Even such a loose bonding would have to depend on substantial progress in the agendas of the September 19 Joint Statement. Once such conditions are met, however, and even a loose union or association comes into being, it will represent, in the peculiar historical context of the Korean Peninsula, an irreversible step toward eventual reunification as well as a maximum possible guarantee for the security of the Pyongyang regime and the stability of inter-Korean economic cooperation. At any rate, the point to stress in connection with regional peace and security is that progress in the international agendas of September 19 Joint Statement depends in turn on progress in the construction of such an inter-Korean institutional framework.
One crucial byproduct of Article 2 may not have been intended by the two leaders. The commitment to a gradual, step-by-step reunification opened up, as in none of the precedent-setting instances of one-shot unification in Vietnam, Germany, or Yemen, the space for participation by ordinary citizens in the process; and at least in South Korea, civil society is sure to enter and appropriate to its use whatever space becomes available. It will do so not only through direct participation in North-South exchanges, but more importantly by means of democratic impact on government policy, including, if necessary, domestic 'regime change' by recourse to the vote. Therefore, I have called South Korea's civil sector (in the wider sense of including business enterprises) 'the third party' in inter-Korean relations.[1] As yet its actual role may not quite match the name, but given that 'reunification Korean-style' is a long drawn-out, open-ended process, its role is bound to increase. Moreover, so long as South Korean democracy retains its vigor, 'the third party', having no fixed term of office, will work as a steadying force amidst the shifting policies of elected governments.
The term 'seventh party' is an extension of this idea to the arena of six-party negotiations. Now, if the claim to being 'the third party' in inter-Korean relations seems somewhat far-fetched, how much more so must sound this notion of a 'seventh party' on the international stage. But the simple fact is that none of the four great powers involved, nor Pyongyang nor Seoul either, seems able to solve the famous conundrum when left to themselves. Not one of the six parties pays much attention to the idea of North-South union or confederation: not the four powers because they consider it none of their business, (except that it is); not North Korea because at the moment they are too preoccupied with immediate survival; and not the Seoul government—which ought to know better, since a union with the North offers no threat to South Korea's democracy or capitalist economy—because it looks askance at any talk of national reconciliation as a politically motivated attack on its 'principled' hard-line stance toward the North. But I submit that once serious efforts for peace and security in Northeast Asia are resumed, sheer horse sense and political realism will come to recognize that the region-wide goals, including the burning issue of denuclearization, will not be achieved unless accompanied by a conscious move toward some (loose) political alignment of the two Koreas.
Needless to say, I do not mean to limit to seven the number of concerned parties in the task of building a peaceful and secure Northeast Asia. At the state level, Mongolia for one will have to come in when the Six-Party Talks have achieved their initial goals and may choose to evolve into a more comprehensive regional framework (say, after the model of the Conference on Security and Cooperation in Europe); and the European Union, either collectively or at the level of individual member states, could play a positive role without formally participating in the Talks. At the level of civil society, too, South Korea obviously will not claim any monopoly of input. The United States and Japan among Six-Party Talks countries are certainly rich in civic movements and independent NGOs. But we cannot expect civil society as a whole in those countries to be sufficiently focused on Korea to qualify as a full-fledged 'party'. As far as the Korean Peninsula, or indeed Northeast Asia, is concerned, much will depend on the initiatives of the 'seventh party' to foster keener interest in, and more effective participation by, citizens of related countries. Both a Korean and Northeast Asian peace and cooperation framework will require in any case greatly expanded 'bottom-up' endeavors, including 'track 2' and 'track 1.5' activities.
If we move beyond security concerns, the wider East Asia rather than Northeast Asia will present itself as the area of regional cooperation. Here the EU model of state-level integration can hardly apply, if only because of the preponderant size and demographic weight of China. The role of civil societies, though at present far more limited than in Europe, will eventually come to play a qualitatively different role insofar as East Asian regional solidarity, if it materializes at all, will take a less sovereignty-oriented form and rely more on civilian exchanges, economic collaboration, and networking among specific localities. To be sure, the role of governments will remain important, and state-level associations—including the already functioning Association of Southeast Asian states (ASEAN)—should be encouraged where relevant. But I have no time to go into this subject, which in my view is closely connected with the theme of peace and security in Northeast Asia.
Afterword (March 28, 2012)
The actual focus of attention at the 2012 New York Conference was (to no one's surprise) not so much on 'the seventh party' but the exchanges between the two major parties most concerned with North Korea's nuclear program, namely, the DPRK (Democratic People's Republic of Korea, or North Korea) and the United States. The discussion reached a high point at a Special Session attended by John Kerry, Chairman of the U. S. Senate Foreign Relations Committee.
The whole conference was run under the Chatham House Rules, allowing public accounts of discussions but without attribution to individual speakers. This inevitably constrains free reflection on the conversations that took place concerning the nuclear issue, but I would like nevertheless to offer some thoughts on the subject, for the issue came to capture public attention with the DPRK's announcement (almost immediately after the conference ended) that it would launch a satellite to commemorate next month's hundredth birthday of the country's founding leader, the late Kim Il Sung.
One of the more impressive and (to most participants) gratifying aspects of the conference was the North Korean delegation's forthcoming attitude toward resolving outstanding issues between DPRK and the U.S, despite their reiterated insistence on the paramount importance of ceasing the hostile U.S. policy toward DPRK as the surest course for resolving the nuclear issue. The U.S. position, as is well known, is that US-DPRK rapprochement will be impossible without some tangible move toward denuclearization on the North Korean side. Yet both sides at the conference seemed genuinely eager to find a meeting point, the direction to which, in my view, was already set by the September 19 Joint Statement's principle of "commitment for commitment, action for action." In any case, there was a clear message from Pyongyang (and I reproduce the wording from memory but without individual attribution), "Our new leadership intends not to fight the United States any more, unlike past generations." It was followed by the assurance that DPRK will faithfully implement the February 29 bilateral agreements, (U.S. nutrition aid and a DPRK moratorium on long-range missile launches and the uranium enrichment program.)
The subsequent announcement of a satellite launch would in any case have invited charges that it was "a deal breaker" (U.S. State Department spokeswoman) and violation of UN Security Council Resolution 1874 prohibiting North Korea from further missile technology tests. To participants of the New York Conference the contrast between the gathering's hopeful atmosphere and the newly heightened tension (including increased perception of DPRK untrustworthiness) could only be the more glaring and enigmatic.
However, as further facts (or reported facts) surfaced, it becomes increasingly dubious whose position, that of the U.S. or the DPRK, is the more enigmatic. Pyongyang insists not only that the satellite launch is one thing and the agreement to freeze long-range missile tests another, but that they informed the U.S. of their intention at the second round of bilateral talks, i.e., before the death of Kim Jong Il in November 2011, as well as at the third round in February 2012. The DPRK also has invited International Atomic Energy Association inspectors to return to monitor the uranium enrichment facilities. In response, the U.S. continues to accuse Pyongyang of violating both the UN resolution and the latest bilateral accord, but it has welcomed the return of IAEA inspectors, i.e., without (thus far) abrogating the accord itself, indicating only that it will not provide the food aid under the present circumstances.
In the light of these developments the New York Conference probably was enacting a more intriguing drama than most participants realized. For, although this can be no more than a conjecture, those in high positions in Washington and Pyongyang, at least Senator Kerry and Vice Foreign Minister Ri Yongho, must have conducted the discussion with knowledge of the planned satellite launch. It is another conjecture of mine that Pyongyang will go on with its plan. How and when, if at all, the two governments then rearrange their priorities to move forward again in line with the principle of "commitment for commitment, action for action" remains to be seen.
[1] See Paik Nak-chung, The Division System in Crisis: Essays on Contemporary Korea (Berkeley, CA: University of California Press, 2011), Chapter 11 'Korean-Style Reunification and Civic Participation: South Korea's Civil Society as the "Third Party" on the Korean Peninsula'.
Asia-Pacific Journal articles on similar topics:
Ruediger Frank, North Korea after Kim Jong Il: The Kim Jong Un era and its challenges
Wada Haruki, Kim Jong-il and the Normalization of Japan-North Korea Relations
Ruediger Frank, Power Restructuring in North Korea: Annointing Kim Jong Il's Successor
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[233 U.S. 70, 71] Messrs. David L. Withington, William R. Castle, W. A. Greenwell, and Alfred L. Castle for plaintiff in error.
[233 U.S. 70, 72] No counsel appeared for defendants in error.
Mr. Justice Holmes delivered the opinion of the court:
This is an action of assumpsit begun on June 30, 1909, in the district court of Honolulu, by garnishment and leaving a copy of the summons at a place which, according to the return, was the defendant's last and usual place of abode, he being absent from the territory. The defendant did not appear and the plaintiff got judgment against the fund on July 2, 1909. No appeal or writ of error was [233 U.S. 70, 73] taken, but on December 31, 1909, the time for suing out a writ of error not having expired, the defendant appeared specially and moved to quash the service and set aside the judgment on the ground that the record showed that there was not sufficient service upon him to comply with the 14th Amendment and the laws of Hawaii. The motion was accompanied by an affidavit to the effect that the defendant had changed his domicil to Australia before the beginning of this suit, that he had returned and lived for a month in January and February, 1909, at the place where the summons was left, and then had gone back to Australia; and that his last and usual place of abode (before his change of domicil, as we understand it) was at Waikiki. The district court overruled the motion and its judgment was affirmed by the supreme court.
The argument for the plaintiff in error assumes a wider range than is open upon this motion. The supreme court says that the question whether the evidence was sufficient to support the judgment cannot be raised in this way, and we should follow the decision even of it seemed less obviously reasonable than it does. Montoya v. Gonzales, 232 U.S. 375, 376 , 58 S. L. ed.--, 34 Sup. Ct. Rep. 413. Moreover, the only errors assigned here are in holding that the service prescribed by 2114 of the Revised Laws of Hawaii, as construed by the court, and that leaving a copy of the summons as above stated after garnishment of a debt due to the defendant, were sufficient to meet the requirements of the 5th Amendment (the court having assumed that the defendant referred to the 5th when he mentioned the 14th in his motion below).
The supreme court was of opinion that, if the question was open, leaving a copy of the summons at the place where the defendant last had stopped was leaving it at his last and usual place of abode within 2114. On that point we see no sufficient reason for disturbing the judgment. Phoenix R. Co. v. Landis, 231 U.S. 578, 579 , 58 S. L. ed.--, 34 Sup. Ct. Rep. 179. Really the only matter before us that calls for a word is [233 U.S. 70, 74] the decision that a judgment appropriating property within the jurisdiction to payment of the owner's debt, which would be good if the property itself were the defendant, is not made bad by the short and somewhat illusory notice to the owner. Upon this point the court below relied upon the above 2114 and Pennoyer v. Neff, 95 U.S. 714, 727 , 24 S. L. ed. 565, 570: 'The law assumes that property is always in the possession of its owner, in person or by agent; and it proceeds upon the theory that its seizure will inform him, not only that it is taken into the custody of the court, but that he must look to any proceedings authorized by law upon such seizure for its condemnation and sale.' It has been said from of old that seizure is notice to the owner. Scott v. Shearman, 2 W. Bl. 977, 979, 11 Eng. Rul. Cas. 17; Mankin v. Chandler, 2 Brock. 125, 127, Fed. Cas. No. 9,030. See Cooper v. Reynolds, 10 Wall. 308, 317, 19 L. ed. 931, 932.
Summons of the defendant's debtor by garnishment is given like effect in express terms by 2114. 'Such notice [i. e., service on the garnishee] shall be sufficient notice to the defendant to enable the plaintiff to bring his action to trial unless the defendant be an inhabitant of this territory, or has sometime resided therein, and then a like copy shall be served personally upon him, or left at his last and usual place of abode.' This statute was in force, no doubt, before the debt garnisheed was contracted, and gave the defendant notice that he must be ready to be represented in order to save a default if the debt was attached. If he had appeared, nothing shows that proper time would not have been allowed to produce evidence at the trial. The district court has jurisdiction over small debts only. Rev. Laws of Hawaii, 1662. Its proceedings naturally are somewhat summary. It appears that the defendant had knowledge of the action before the time for a writ of error had expired, and when it may be that it still would have been possible to set aside the judgment and to retry the case. He did not adopt the course that [233 U.S. 70, 75] would have opened effective ground of attack even as the record stood. We cannot discover that he has suffered any injustice-still less that he has been subjected to an unconstitutional wrong.
Judgment affirmed.
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