Enhancing the Global Pharmacovigilance  System Establishing Quality Assurance Policies TEchnoloGy & mAnUFAcTURInG Introducing Universal Design to Product  Packaging Measures to Prevent Medical Malpractice and to Improve the Distinguishability of  Pharmaceuticals We have formulated the Astellas Quality Assurance Manual,  which governs Group-wide policies on quality assurance. Based  on this manual, we prepare guidelines and standard operating  procedures concerning operational management and procedures  for a variety of quality assurance tasks and quality assurance  systems at the global, regional and national levels. In addition, these documents are revised regularly and as  necessary. We have a system in place that is able to respond  swiftly to developments in the external environment, such as  regulatory changes and amendments. Furthermore, we have assigned quality assurance officers in  Japan, the U.S. and Europe in order to promote Astellas’ quality  assurance efforts on a global basis. Each of these officers works  closely with one another to increase awareness of these  manuals, guidelines, standard operating procedures, etc.,  among employees.  From fiscal 2012, Astellas began taking several initiatives aimed  at establishing a high-quality global pharmacovigilance system  that can address the different regulatory requirements of various  countries. Specific initiatives included establishing an organization  that can globally integrate and implement operations previously  conducted in each region, improving business processes and  systems, and integrating the database on safety information  worldwide. We also established the “Astellas Corporate Pharma- ceutical Products Safety Policy,” which defines the roles that  should be fulfilled by all employees, including contract employ- ees. These initiatives have further enhanced the consistency and  efficiency of Astellas’ pharmacovigilance functions from the  clinical development to post-marketing stages. In drug manufacturing, we place the highest priority on ensuring  a stable supply of high-quality pharmaceuticals. To ensure this,  we have established our own standards which comply with GMP.  Under these standards, we apply rigorous high-standard quality  assurance that encompasses manufacturing facilities and equip- ment, as well as all stages from the procurement of raw materials  through to storage, manufacturing processes and shipments. We  are also working to develop packaging designs from the stand- point of patients and medical professionals for the purpose of  reducing the risk of any misuse of medicines. We have introduced universal design to certain product packag- ing. One example is the universal design packaging of Bonoteo  50 mg tablets, which is administered once every 4 weeks and  features packaging with outstanding opening and resealing  properties. To prevent patients from forgetting to take the drug,  there is a space provided on the packaging to write in the day  when the drug should be taken. A decal to be used as a calen- dar is also attached. In addition, the packaging uses a universal  design font type. Astellas strives to supply products from the users’ perspective to  ensure that medical professionals and patients do not mistake  one drug for another. We are taking a number of steps to prevent  medical malpractice in this respect, including printing product  names directly on capsules and tablets, and adopting new bar- code printing on packaging sheets (blister sheets) in which the  drug name and dosage can be identified even after the blister  sheet is split apart. To make drugs easier to identify visually, we  have adopted easily discernible colors and font types for the  blister sheets of certain products. This is part of our efforts to  make it harder to misread blister sheet labeling. Bonoteo 50 mg tablet box  Astellas Pharma Inc.  _ Annual Report 2014 56