Good Manufacturing Practices Services

GMPs help create systems that ensure proper design, monitoring, and control of manufacturing processes and facilities. When applied as designed, GMPs help prevent instances of contamination, mix-ups, deviations, failures, and errors. USP offers the following Good Manufacturing Practices (GMP) Services:

  • Good Manufacturing Practices (GMP) Audit Only Program: USP’s Good Manufacturing Practices (GMP) Audit Only Program for dietary supplement manufacturers helps ensure manufacturing sites conform with current Good Manufacturing Practices (cGMPs) based on regulatory and industry standards. The audit is a component of the Dietary Supplement Verification Program (DSVP), covering dietary supplement manufacturing facilities.
  • Good Manufacturing Practices (GMP) Gap Audit Program: The Good Manufacturing Practices (GMP) Gap Audit Program provides a comprehensive current GMP assessment to help a manufacturer or supplier get a better understanding of potential gaps in their production systems. Adherence to current GMP regulations ensures the identity, strength, quality, and purity of products and ingredients to adequately control manufacturing operations.

During the GMP Audit Only and GMP Gap Audit Assessment, USP analyzes conformance with current GMPs for six production systems:

  • Quality Management System: Helps ensure overall conformance with GMPs and internal procedures and specifications
  • Facilities and Equipment System: Includes activities that provide an appropriate physical environment and resources used in the production of products
  • Material System: Includes measures and activities to control raw material ingredients, other components, intermediates, containers, and labels
  • Production System: Includes measures and activities to control the manufacture of products
  • Packaging and Labeling System: Includes measures and activities that control the packaging and labeling of products
  • Laboratory and Control System: Includes measures and activities related to testing raw materials and finished product for conformance to specifications
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USP Quality Systems GMP Audited Certification Program Manual

View Participant Manual

View the USP GMP Audit Only Program Participant Manual for dietary supplement manufacturers to learn more.

View Participant Manual

Program Participants

Program Participants

View participants in USP's GMP Audit Only Program.

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