GMP/cGMP

Who has to comply

Manufacturers, packagers, testers, and holders of medicinal products and active substances for any regulated market, plus dietary supplement and device makers under their specific rules.

The trigger is placing product on a regulated market or supplying a regulated customer; contract manufacturers and laboratories are covered through both direct inspection and their clients' supplier requirements.

What the assessor asks to see

Site master file or facility overview; pharmaceutical quality system description and quality unit responsibilities; written procedures for all GMP operations; master and executed batch records; specifications, analytical methods, and validation; stability program; facility and utility qualification, equipment qualification, cleaning validation, process validation; change control, deviation, and CAPA records; complaint and recall records; supplier and contract giver/acceptor agreements and audits; training and qualification records; product quality reviews; data integrity governance including audit trails and access control; previous inspection reports and commitments.

Where the requirement sits: See 21 CFR 211 and 21 CFR 111

Which GMP applies

US market: 21 CFR 210/211 for finished drugs (see the 21 CFR 211 profile), Part 111 for dietary supplements, Part 820 for devices. EU and EEA: EudraLex Volume 4 and its annexes (Annex 1 sterile products, Annex 11 computerized systems, Annex 15 qualification and validation, and others) enforced by national authorities.

Many other countries adopt WHO GMP or the PIC/S guide, which is kept aligned with EudraLex Volume 4. Active substance makers follow ICH Q7, adopted as EudraLex Volume 4 Part II and as FDA guidance.