Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
|Publication Date:||7 July 2016|
This Standard is intended to define Good Manufacturing Practices (GMP) for excipient manufacture and distribution3 for use in drug products. It sets minimum requirements for GMP applicable to all commercially available excipients.
This Standard includes the minimum requirements of a quality management system for excipient manufacture drawing on principles of GMP and quality systems from other relevant standards such as those referenced in section 2.2.
NOTE 1 - The requirements of this Standard may not be sufficient for all applications of excipients. It is the user's responsibility to determine whether or not this Standard meets the requirements for their intended use.
NOTE 2 - Auditing excipient manufacturers ensures conformance to this Standard. This Standard is also intended to be used by duly accredited or otherwise suitably qualified 3rd parties.
NOTE 3 - Each user of a 3rd party auditing service should make its own determination as to the qualifications of the 3rd party and the applicability of the report and/or certificate issued in satisfying its requirements, including those pertaining to its intended use of the excipient.
Excipients impact the appearance, stability, and delivery of drug products and are essential to the safety, quality, and efficacy of these products. It is not possible to assure the consistent quality of excipients by testing alone. Adherence to excipient Good Manufacturing Practices provides assurance that excipients are suitable for use in drug products. Excipient Good Manufacturing Practices require a proper quality management system, methods, facilities and controls, including appropriate tests.
3 GMP applies to distribution per the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 501(a) (2) (B).