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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
34None 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}}34None 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}}
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+36The 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}}
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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>
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41== See also ==44== See also ==