Good manufacturing practice (revision 15)
Old revision·16:46, 25 Feb 2025·GreyMarketGreer
| Good manufacturing practiceRegulatory framework | |
|---|---|
| Abbreviation | GMP, cGMP |
| For APIs | ICH Q7 |
| Core principle | Quality is built in, not tested in |
| Distinct from | ISO 9001, a management-system standard |
| Topic infobox · conventions | |
Good manufacturing practice (GMP) is the body of requirements governing how medicinal products and their active ingredients are manufactured, documented, controlled and released. Its central principle is that quality is built into a product by a controlled process rather than tested into it afterwards.[1]
GMP is jurisdictional. A claim of GMP compliance is meaningful only in relation to a regulator, a scope and a period, and "GMP-certified" without those particulars is not a checkable statement — regulators inspect and issue findings rather than issuing perpetual certificates.[1]
It is also distinct from ISO 9001, which certifies a quality management system against a general standard and is issued by a certification body rather than a medicines regulator. Both can be genuine; they establish different things.[2]
What GMP requires
[edit]The requirements cover premises and equipment, personnel and training, documentation and records, materials management, production and in-process controls, packaging and labelling, storage and distribution, laboratory controls, validation, change control, deviation and complaint handling, and recall capability.[1]
Documentation is the connective tissue. A batch record contemporaneously documents what was done, by whom, with which materials, and what the in-process results were — which is what makes traceability possible at all rather than merely asserted.
Validation is the other structural element. A process is demonstrated to produce conforming material reproducibly, and thereafter is operated within the validated parameters; a change outside them requires assessment before implementation. This is why GMP is a system claim rather than a product claim.[1]
What a GMP claim on a research chemical means
[edit]Research chemicals are not medicinal products, and GMP does not apply to them by operation of law. A supplier may nonetheless operate parts of its facility to GMP for other customers, and material made in such a facility may be described accordingly.[1]
| Claim | What would make it checkable |
|---|---|
| GMP-certified | Which regulator, which scope, which inspection date |
| Made in a GMP facility | Which facility, which registration |
| ISO 9001 certified | Certification body, certificate number, scope, validity |
| GMP-compliant process | Compliant with which requirements, assessed by whom |
None of these claims is inherently false and none is inherently meaningful. Each becomes checkable with particulars, and the absence of particulars is a property of the claim rather than of the material.[2]