Good manufacturing practice (revision 34)

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]

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]

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]

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]

The narrower and more common situation is that a certificate names an ISO 9001 certification, which is a genuine and verifiable thing about a management system and says nothing directly about the material in the vial.^[3]

The principle has a direct bearing on how much weight a certificate can carry. End-product testing has limited power to detect problems that occur intermittently — the same statistical argument that limits sterility testing — so a system that prevents them is worth more than a determination that looks for them.^[1]

For a purchaser who can see only the document, this is uncomfortable: the thing that matters most is the least visible. What is visible is the documentary discipline the system produces — lot-specific certificates, retrievable records, named methods, consistency over time — and that visibility is why those features are worth attention.^[4]

The inference runs one way only. Good documentation is consistent with a good system and is also achievable without one; poor documentation establishes little about the material. See Test report forgery.^[3]

• ISO 9001
• Active pharmaceutical ingredient
• Lot traceability
• Certificate of analysis
• Contract development and manufacturing organisation