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 and dietary ingredient 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) and the Ingredient Verification Program for Dietary Ingredients, as a preliminary assessment.
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

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

View participants in USP's GMP Audit Only Program.

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Questions about becoming USP Verified? Reach out to us at USPVerified@USP.org or fill out the contact form below and we will be in touch.

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