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 deviations, and maintaining validated quality control testing laboratories.