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Quality

GPhA Position

Science and quality are the cornerstones of the generic pharmaceutical industry.  GPhA and its member companies strongly support strict enforcement of the rigorous good manufacturing requirements set by the FDA.  Specifically, the generic pharmaceutical industry utilizes a modern, scientific and risk-based pharmaceutical quality system as part of its commitment to excellence.  Like the brand industry, generic manufacturers embrace FDA principles set forth in the Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach and the Process Analytical Technology initiative, which help assure product quality through design and performance-based specifications.  Members of the generic pharmaceutical sector consistently make substantial investments in manufacturing facilities and their drug testing infrastructure to ensure product integrity, quality assurance and quality control.

Key Points
  • FDA requires that a generic drug contain the same active ingredient and be manufactured to the identical strength and dosage form as the counterpart brand-name drug.  Generic drugs also have the same indications of use, dosing and labeling, and provide the same quality, potency, efficacy and safety profile to patients as their counterpart brands.
  • FDA requires generic drug manufacturers to meet the same batch-to-batch requirements for strength, purity, and quality as the original manufacturer and follow the same strict current Good Manufacturing Practices (cGMP) rules.
  • Generic drugs must be bioequivalent to their counterpart brand drugs, meaning that the active ingredient in a generic medicine is absorbed into the body at the same rate and amount as in the brand-name product. This ensures that the generic delivers the same therapeutic effect as the brand counterpart and can be safely substituted with the brand product.
  • Approximately 80% of the prescriptions dispensed in the U.S. are filled with FDA-approved generic medicines.  The FDA consistently confirmed the safety of generic medicines through frequent public statements to assure physicians, pharmacists and consumers that they can expect the same quality, efficacy and safety of a brand product when choosing to use a generic.
  • FDA’s approval process for generic drugs is as stringent and rigorous as the process followed to approve brand drugs. The rigorous chemistry, manufacturing and controls phase is applicable to both new brand drugs and generic drugs. Labeling and testing requirements also are the same for both brand and generics. The same FDA field inspectors evaluate the manufacturing facilities for generics and for brand products, using the same standards, to ensure compliance with all good manufacturing practices.

GPhA Efforts

  • GPhA is engaged in 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.

  • GPhA's Science Interaction agenda 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.

  • GPhA collaborates with the International Conference on Harmonization on issues related to drug product quality, 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.

 

Press Releases

 

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