Initiatives to Provide High-quality Pharmaceuticals

Management of Quality Assurance

Management of Quality AssuranceThe production of pharmaceuticals requires a high level of quality assurance. Consequently, rigorous Good Manufacturing Practice (GMP) standards have been established in many countries. Our pharmaceuticals are exported around the world after obtaining regulatory approvals from government institutions of importing nations, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Australia's Therapeutic Goods Administration (TGA). Operating standards in the Sumitomo Dainippon Pharma Group are consistent with the GMP standards of Europe and the United States. Furthermore, we have established a high level of facility design and a quality assurance system able to pass the most rigorous audits by overseas partners while meeting strict quality standards at the global level by following the guidelines of the International Conference on Harmonisation (ICH), which deliberates on the harmonization of EU, U.S. and Japanese pharmaceutical regulations.

The standards for quality assurance are expected to become increasingly rigorous. The Sumitomo Dainippon Pharma Group is therefore making proactive investments in manufacturing facilities--including a new solid dosage form facility and restricted access barrier system (RABS) that increases the level of sterility assurance--to meet future standards. We are focusing our efforts on strengthening our supply system to continue providing pharmaceuticals of increasingly high quality.

Prompt Responses to Inquiries Using a Unique Information System

Prompt Responses to Inquiries Using a Unique Information SystemSumitomo Dainippon Pharma's Quality Information System is designed to ensure prompt responses to inquiries regarding product quality from medical institutions. We use this system in order to respond to Quality Information under the Good Quality Practice (GQP)*1 ordinance.

When an inquiry is submitted to our Quality Information System by a medical institution, the plant at which the product was manufactured takes immediate steps, checking reference samples from the same lot, and verifying manufacturing records to confirm the quality of the product in question. The underlying cause of the incident is also investigated, and when necessary, the plant develops and implements preventive measures.

Members of departments such as Safety Management, Pharmacovigilance, Sales & Marketing, Manufacturing, and Quality Assurance can access the system so that they can promptly evaluate safety and provide replacements for the products if needed. Our Quality Information System also has a search function which enables us to analyze quality issue trends per each product type and time period to prevent similar problems in the future. Since fiscal 2012, our medical representatives (MRs) have also been able to access this system from their tablet devices, which allows them to refer to basic answers for FAQs. This has made it possible for Sumitomo Dainippon Pharma to provide faster response to inquiries from clients.

*1 Good Quality Practice: A standard for managing the quality of pharmaceuticals, quasi-pharmaceuticals, cosmetics and medical devices (manufacturing and marketing quality assurance standard).

Efforts of Global Safety Information

Adverse reactions that were unpredictable during the development stage can appear once pharmaceuticals have started to be used by a large number of patients under various conditions after manufacturing and marketing approval. Therefore, it is important to promote a proper use of pharmaceuticals by collecting and evaluating a wide range of information on safety and efficacy and assessing their benefit and risk in post-marketing period. It is also important to promptly provide necessary information to hospitals and clinics for ensuring proper usage of the products.

In Japan, we are working strenuously to ensure the safe and proper use of our pharmaceuticals through pharmacovigilance activities in compliance with the Pharmaceuticals, Medical devices and Other Therapeutic Products Act and Good Vigilance Practice (GVP)*1.

Moreover, we have developed a global pharmacovigilance system that covers our Group companies outside Japan. This global system helps us to manage and evaluate all safety information on products developed and marketed in multiple countries and to develop the measures required for securing the safety of our pharmaceuticals.

*1 Good Vigilance Practice: A standard for managing the post-marketing safety of pharmaceuticals, quasi-pharmaceuticals, cosmetics and medical devices (post-marketing safety management standard).

Prompt and Accurate Provision of Information to Medical Institutions

Sumitomo Dainippon Pharma promptly and accurately provides medical institutions with updated information on proper usage of its products in order to maximize the efficacy and safety of each pharmaceutical.

For example, when new precautions are added to package inserts, we provide "Notice of Revisions to Precautions" to physicians and pharmacists using our products. This notice explains about possible side effects to watch for, symptoms of these side effects, and how to treat them.

We also prepare documents such as "Guides to Medications" and "Instructional Leaflets" which are distributed to medical institutions. These documents are used by medical experts in explaining to patients about how to take medications or what symptoms to watch for as a sign of a side effect. Illustrations are used in the "Instructional Leaflet" so that the elderly and children can easily understand about how to take drugs and about possible side effects.

In fiscal 2012, our MRs also started using tablet devices to provide safety information. This helps our MRs offer accurate and easy-to-understand information to medical institutions more quickly.

Flowchart:Safety Information

Production Information System "DI-SaGaS"

Drugs are truly effective only when users obtain information that helps them use drugs properly and safely. At Sumitomo Dainippon Pharma, we believe that prompt and accurate provision of product information will enhance the value of our drugs for customers.
In order to achieve that purpose, we utilize a unique product information search system called "DI-SaGaS" to respond to inquiries from medical professionals to our MRs and Pharmaceuticals Information Center.

As there is a growing demand for drug safety information from medical professionals, we will continuously revise and enhance the contents of our system to meet their needs. We will also strive to provide information that is more trustworthy and satisfactory for customers.

Overview:Product Information System 「DI-SaGaS」