GMP
Short for Good Manufacturing Practice
Regulatory requirements ensuring pharmaceutical, medical device, and food products are consistently produced to quality standards.
Definition
Good Manufacturing Practice (GMP, or cGMP — 'current' GMP) is the collection of regulations that govern how pharmaceuticals, medical devices, food products, and cosmetics must be manufactured, tested, and distributed. In the US, GMP requirements are codified in 21 CFR Parts 210 and 211 for drugs, 21 CFR Part 820 for medical devices (QSR), and 21 CFR Part 117 for food (the FSMA Preventive Controls Rule). GMP mandates written procedures for nearly every activity, from batch records to cleaning to deviation investigations, and requires training records for every operator.
Why it matters
An FDA 483 observation for inadequate GMP documentation can shut down production, trigger product recalls, and cost millions in remediation. The overwhelming majority of FDA enforcement actions cite deficient procedures or failure to follow documented SOPs. In a GMP environment, your SOP library is literally a regulated asset — its completeness and currency determine whether you can legally ship product.
Related terms
A documented, step-by-step process for performing a routine business task consistently and safely.
A structured process for investigating quality problems, implementing fixes, and preventing recurrence. Core to ISO 9001 and FDA quality systems.