Issues

GPhA Position

The Generic Pharmaceutical Association is committed to excellence in the sciences to maintain the highest level of quality, safety and efficacy in generic pharmaceuticals. This applies both to finished dose products and raw materials used in the manufacturing of finished dose products. To achieve this desired objective, GPhA and its member companies are committed carrying out several critical actions under our Science Interaction agenda. This includes ongoing collaborations with the FDA on science initiatives such as the Pharmaceutical Quality Initiative for the 21st Century and Quality by Design (QbD) program. Under the QbD system, products are designed to meet patient needs and performance requirements and the process is designed to consistently meet critical quality attributes. The process is continually monitored, evaluated and updated to allow for consistent quality over time.

Background

GPhA's Science Interaction agenda also includes working closely with the United States Pharmacopeia, the organization in the U.S. that sets drug quality standard to assure that the most modern technology is used in drug testing. This provides the highest expectancy that manufacturing standards keep pace with knowledge and technology. We also are continuing our collaborations with the International Conference on Harmonization related to drug product quality issues, and ASTM International (formerly the American Society of Testing and Materials) and other organizations that adopt technology standards that are relevant to the pharmaceutical industry. In all of these areas, GPhA eagerly supports conferences and workshops to address emerging science and technology as it applies to pharmaceuticals.

Related Information

Testimony & Content

September 26, 2011 - GPhA President and CEO Ralph G. Neas Remarks before CDER Drug Shortage Workshop (186.22KB PDF)