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Quality

GPhA Position

Patients, consumers and health professionals can be assured that FDA approved generic drugs have met rigid standards. To gain FDA approval, a generic drug must:

  • Contain the same active ingredients as its brand counterpart
  • Be identical in strength, dosage form and route of administration
  • Have the same use indications
  • Be bioequivalent
  • Meet the same batch requirements for identity, strength, purity and quality
  • Be manufactured under the same strict standards of FDA good manufacturing practice regulations for innovator product

Key Points
  • More than 80% of the prescriptions dispensed in the U.S. are filled with FDA-approved generic medicines. The FDA consistently confirms the safety of generic medicines. 
  • Physicians, pharmacists and patients 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.
  • 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 have the same indications of use, dosing and labeling as the brands. These medicines provide the same quality, potency, efficacy and safety profile to patients as their brand counterparts. Generic drugs do not need to contain the same inactive ingredients as the brand. 
  • Many brand and generic manufacturers produce products globally. All manufacturing facilities that produce drugs for the U.S. market must comply with U.S. requirements and are routinely inspected by the FDA.
  • 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 the brand counterpart, also known as its 'reference product.' This means that the active ingredient in a generic medicine is absorbed into the body at the same rate and amount, ensuring that the generic delivers the same therapeutic effect as the brand and can be safely substituted for the brand product.
  • The rigorous chemistry, manufacturing and controls phase is applicable to both new brand drugs and generic drugs. All generic manufacturing, packaging and testing sites must pass the same quality standards as the brand. 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

  • The generic pharmaceutical industry pays user fees to the FDA through the Generic Drug User Fee Act (GDUFA). For more information on ways that GDUFA impacts safety and quality, and enhances the abbreviated new drug application (ANDA) approval process for generic drugs, visit www.gdufanow.org

  • 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 works 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

 

Related Information