Good manufacturing practice: difference between revisions
Diff·revision 16 → 17·13:48, 1 Apr 2025
Difference between revision 16 and revision 17 of Good manufacturing practice. 3 lines changed; the page grew by 371 bytes.
| Revision 16 — 08:22, 16 Mar 2025 MOTSc_Mira (talk) add the note that a certificate of analysis has no regulatory standing 3,548 bytes ±0 | Revision 17 — 13:48, 1 Apr 2025 IsocraticIla (talk) clarify that a business licence is not a manufacturing authorisation 3,919 bytes +371 | ||
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| 34 | 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.{{r|iso9001}} | 34 | 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.{{r|iso9001}} |
| 35 | 35 | ||
| + | 36 | 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.{{r|reports}} | |
| + | 37 | ||
| 36 | == References == | 38 | == References == |
| 37 | {{reflist}} | 39 | {{reflist}} |
| 38 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 40 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 39 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 41 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> |
| + | 42 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | |
| 40 | 43 | ||
| 41 | == See also == | 44 | == See also == |