Good manufacturing practice: difference between revisions
Diff·revision 12 → 13·20:12, 17 Jan 2025
Difference between revision 12 and revision 13 of Good manufacturing practice. 16 lines changed; the page grew by 792 bytes.
| Revision 12 — 17:16, 3 Jan 2025 GreyMarketGreer (talk) de-orphan 2,538 bytes +37 | Revision 13 — 20:12, 17 Jan 2025 ShortageShona (talk) rm the claim that the position has changed; no source supports it 3,330 bytes +792 | ||
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| 22 | 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}} | 22 | 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}} |
| 23 | 23 | ||
| + | 24 | == What a GMP claim on a research chemical means == | |
| + | 25 | 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.{{r|ich_q7}} | |
| + | 26 | ||
| + | 27 | | Claim | What would make it checkable | | |
| + | 28 | |---|---| | |
| + | 29 | | GMP-certified | Which regulator, which scope, which inspection date | | |
| + | 30 | | Made in a GMP facility | Which facility, which registration | | |
| + | 31 | | [[ISO 9001]] certified | Certification body, certificate number, scope, validity | | |
| + | 32 | | GMP-compliant process | Compliant with which requirements, assessed by whom | | |
| + | 33 | ||
| 24 | == References == | 34 | == References == |
| 25 | {{reflist}} | 35 | {{reflist}} |
| 26 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 36 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 27 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 37 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> |
| + | 38 | ||
| + | 39 | == See also == | |
| + | 40 | * [[ISO 9001]] | |
| + | 41 | * [[Active pharmaceutical ingredient]] | |
| + | 42 | * [[Lot traceability]] | |
| + | 43 | * [[Certificate of analysis]] | |
| 28 | 44 | ||
| 29 | {{DEFAULTSORT:Good manufacturing practice}} | 45 | {{DEFAULTSORT:Good manufacturing practice}} |