Good manufacturing practice: difference between revisions
Diff·revision 5 → 6·21:03, 5 Oct 2024
Difference between revision 5 and revision 6 of Good manufacturing practice. 5 lines changed; the page grew by 666 bytes.
| Revision 5 — 14:15, 23 Sep 2024 TitrationTheo (talk) add category for drug regulation 1,773 bytes ±0 | Revision 6 — 21:03, 5 Oct 2024 Chromatokid (talk) add the customs-detention point with its source 2,439 bytes +666 | ||
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| 11 | 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.{{r|ich_q7}} | 11 | 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.{{r|ich_q7}} |
| 12 | 12 | ||
| + | 13 | It is also distinct from [[ISO 9001|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.{{r|iso9001}} | |
| + | 14 | ||
| 13 | == What GMP requires == | 15 | == What GMP requires == |
| 14 | 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.{{r|ich_q7}} | 16 | 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.{{r|ich_q7}} |
| ⋮ | ⋮ | ||
| 16 | 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 [[Lot traceability|traceability]] possible at all rather than merely asserted. | 18 | 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 [[Lot traceability|traceability]] possible at all rather than merely asserted. |
| 17 | 19 | ||
| + | 20 | 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.{{r|ich_q7}} | |
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| 18 | == References == | 22 | == References == |
| 19 | {{reflist}} | 23 | {{reflist}} |
| 20 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 24 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| + | 25 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | |
| 21 | 26 | ||
| 22 | {{DEFAULTSORT:Good manufacturing practice}} | 27 | {{DEFAULTSORT:Good manufacturing practice}} |