What does cGMP mean?
cGMP refers to the current Good Manufacturing Practice regulations enforced by the U. S. Food and Drug
Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The regulations are in 21 CFR, parts 210
and 211. The purpose of these regulations is to assure the identity, strength, quality, and purity of drug products by requiring
that peptide manufacturers adequately control manufacturing operations. This includes excellent quality
management systems, robust peptide supply chain management and risk mitigation, obtaining high-quality raw
materials, establishing and validating operating procedures (SOPs), detecting and investigating product quality
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