What is cGMP?
Current Good Manufacturing Practice: FDA regulations (21 CFR Parts 210/211) ensuring pharmaceutical products are consistently produced and controlled according to quality standards.
cGMP covers the full quality system: facilities and equipment, personnel qualification, production and process controls, laboratory controls, records, and a quality unit with authority to reject product. The 'c' — current — means the FDA expects practices to keep pace with modern technology and knowledge.
503B outsourcing facilities must comply with cGMP; 503A pharmacies generally follow USP chapters instead, though the distinction narrows when state boards adopt stricter requirements or the FDA investigates a quality event.
See how CompliRx handles this in practice:
503B compliance softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.