scope:

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.

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 third-party audit and certification providers.

NOTE 3 - Each user of a third-party auditing service should make its own determination as to the qualifications of the third 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.

Purpose

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 GMP provides assurance that excipients are suitable for use in drug products. Excipient GMP require a proper quality management system (QMS), test methods, and facilities and controls.

³ GMP applies to distribution per the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC. 501(a) (2) (B).