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## Establishing Quality Assurance Policies 

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. 

## TEchnoloGy & mAnUFAcTURInG 

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. 

## Measures to Prevent Medical Malpractice and to Improve the Distinguishability of Pharmaceuticals 

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. 

## Enhancing the Global Pharmacovigilance System 

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. 

## Introducing Universal Design to Product Packaging 

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. 

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