GMP

Also known as: Good Manufacturing Practice

The quality-control standards drug manufacturers must follow.

Definition

Good Manufacturing Practice (GMP) is the regulatory framework governing pharmaceutical manufacturing quality: facility design, equipment, processes, personnel training, documentation, and quality control. FDA cGMP (current GMP) is codified in 21 CFR 210/211. GMP inspection failures are a leading cause of CRLs.

See also

• CRL — The FDA notification that an NDA or BLA cannot be approved in its present form.

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval