21 CFR Part 11: A Brief Overview of cGMP Manufacturing companies in the life sciences must follow FDA 21 CFR 11 and EU GMP Annex 11 requirements in order to sell products in the US and EU. As many organizations across the industry scale up production from clinical to commercial operations, adequate documentation and access […]

Good manufacturing practice (GMP) is a set of guidelines that manufacturers must follow to ensure that their products are safe, compliant, and high-quality. The FDA lays down these guidelines to provide a thorough and unadulterated process of product manufacture. GMP focuses on processes and procedures to reduce the risk of introducing contaminants or non-approved substances […]