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Good Manufacturing Practice (GMP) Resources | ISPE | International Society for Pharmaceutical Engineering
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class="tex2jax_process"><p><strong>Good Manufacturing Practice</strong> (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.</p><p><strong>GMP</strong> covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. </p><a href="/node/273265"><img src="/sites/default/files/2024-08/Horizontal%20AM.png" alt="2024 Annual Meeting"></a><hr><h3 class="text-x-pe-darkblue">GMP Resources</h3><ul><li><a href="/initiatives/regulatory-resources/gmp/what-is-gmp" data-entity-type="node" data-entity-uuid="0e9ae206-16b5-44f1-831c-ba82e513b196" data-entity-substitution="canonical" target title="What is GMP?">What is GMP?</a></li><li><a href="/initiatives/regulatory-resources/gmp/regulations" data-entity-type="node" data-entity-uuid="c597b0dc-1055-4252-9f6e-2b552ad58a8a" data-entity-substitution="canonical" target title="GMP Regulations and Preambles">GMP Regulations and Preambles</a></li><li><a href="/initiatives/regulatory-resources/gmp/regulatory-guidelines" data-entity-type="node" data-entity-uuid="7ecd5029-039d-4995-b410-a299622d8ced" data-entity-substitution="canonical" target title="GMP Guidelines">GMP Guidelines</a></li><li><a href="/initiatives/regulatory-resources/gmp/audit-resources" data-entity-type="node" data-entity-uuid="a5f6a85b-db47-45d0-8af2-0dac8aaec959" data-entity-substitution="canonical" target title="GMP Audit Resources">GMP Audits</a></li><li><a href="/initiatives/regulatory-resources/gmp/resouces-country" data-entity-type="node" data-entity-uuid="f284a8ff-ec4d-49a7-abc4-4c7f775bc9f3" data-entity-substitution="canonical" target title="GMP Audit Resources by Country">GMP Resources by Country</a></li><li><a href="/topics/gmp" title="Most Recent Content" data-entity-type="node" data-entity-uuid="f8229770-3503-4a81-9f09-0af9f65547e6" data-entity-substitution="canonical" target>Browse Resources by Topic</a></li></ul><hr><h3 class="text-x-pe-darkblue">Community of Practice</h3><p>Join an ISPE community of practice to participate in discussions on specific topics with your peers. 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CFR Part 111: Dietary Supplements</a></li><li><a href="/publications/guidance-documents/regulation-handbooks-21-cfr-part-210-211-pharmaceuticals" data-entity-type="node" data-entity-uuid="df8162ed-512a-42a1-8d9f-86a7b9ac5a4e" data-entity-substitution="canonical" title="GMP Regulation Handbook: General, Finished Pharmaceuticals, 21 CFR Parts 210 & 211">21 CFR Part 210 & 211: Pharmaceutical</a></li><li><a href="/publications/guidance-documents/regulation-handbooks-ich-q7a-active-pharmaceutical-ingredients" data-entity-type="node" data-entity-uuid="7cd7f559-7941-4bf7-a279-8664bb8b066a" data-entity-substitution="canonical" title="GMP Regulation Handbook: Active Pharmaceutical Ingredients, ICH Q7">ICH Q7A: Active Pharmaceutical Ingredients</a></li><li><a href="/publications/guidance-documents/regulation-handbooks-ich-q8r2-pharmaceutical-development" data-entity-type="node" data-entity-uuid="d457bed4-b5db-4b6a-a0c2-1932e2629f8b" data-entity-substitution="canonical" title="GMP Regulation 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