Framework Quality & Manufacturing
GMP/cGMP
Good manufacturing practice (GMP) is the family of rules that require medicines, medical products, and related goods to be made consistently and controlled to the quality standards their intended use demands.
It exists in several legal forms: the US FDA's current GMP (cGMP) in 21 CFR Parts 210 and 211 for drugs, Part 111 for dietary supplements, and Part 820 for devices; the EU's EudraLex Volume 4 GMP guide with its annexes; the WHO GMP guidelines used by many national regulators and by WHO prequalification; and the PIC/S guide, which harmonizes inspection practice across more than 50 regulatory authorities.
The core content is similar everywhere: a pharmaceutical quality system, qualified personnel, controlled premises and equipment, documented procedures, validated processes, batch records, laboratory controls, and handling of complaints and recalls.
In writing, every GMP regime expects a quality manual or site master file, written procedures for every operation that affects quality, master and batch records, specifications, validation and qualification documents, change control, deviation and CAPA records, training records, and a data integrity framework so that records can be trusted.
Which regulator inspects depends on where the product is made and sold.
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.
What AllyMatter does here
Written-procedure and training-acknowledgment layer.
AllyMatter publishes this site.
Assessors
Who assesses GMP/cGMP
Government inspectors: FDA investigators in the US; national competent authority GMP inspectors in the EU (issuing GMP certificates recorded in EudraGMDP); WHO prequalification inspection teams; other national regulators, many coordinated through PIC/S. Third-party GMP audits by customers or contracted auditors supplement but do not replace regulatory inspection.
(regulatory inspection). PIC/S membership involves peer assessment of the regulator's inspectorate, and mutual recognition agreements (for example US-EU) allow regulators to rely on each other's inspections.
No firm has claimed a GMP/cGMP assessor listing yet. Claim yours →
Consultants
Who helps with GMP/cGMP
A large global consultant ecosystem exists, from individual former inspectors to major quality consultancies. Consultants write and remediate quality systems, run mock inspections against FDA, EU, or PIC/S expectations, lead validation and data integrity programs, and manage responses to inspection findings.
Engagements range from short readiness audits to multi-year remediation.
Firms that name this framework in their own material. Listings we have not verified yet come from public filings and partner lists. Each firm can confirm its own.
No firm has claimed a GMP/cGMP consultant listing yet. Claim yours →
Software
Tools for GMP/cGMP
Tools that name this framework in their own material.
Related reading
- Global harmonisation of GMP standards: navigating differences between FDA, EMA and PIC/SSide-by-side comparison of the three GMP regimes, including the Qualified Person concept that has no US equivalent.PharmOut
- GMP news and guidance archiveRunning commentary from a GMP professional body on annex revisions, inspection findings and regulator guidance across the EU and PIC/S.European Compliance Academy
Independent third-party explainers, chosen by hand. Not affiliated with this site and not paid placements. All links are nofollow.
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From the publisher
Run the Policy Side of GMP/cGMP in AllyMatter
Approve the policies GMP/cGMP asks for, keep every version, and record a named acknowledgment from each person who has to read them.