Good manufacturing practice: difference between revisions
Diff·revision 18 → 19·04:58, 8 May 2025
Difference between revision 18 and revision 19 of Good manufacturing practice. 7 lines changed; the page grew by 982 bytes.
| Revision 18 — 07:28, 20 Apr 2025 GMP_Gita (talk) add the good-manufacturing-practice framework by name 3,919 bytes ±0 | Revision 19 — 04:58, 8 May 2025 ListMakerLumi (talk) clarify that personal importation and commercial importation are different questions 4,901 bytes +982 | ||
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| 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}} | 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 | 37 | ||
| + | 38 | == Why "built in, not tested in" matters here == | |
| + | 39 | The principle has a direct bearing on how much weight a [[Certificate of analysis|certificate]] can carry. End-product testing has limited power to detect problems that occur intermittently — the same statistical argument that limits [[Sterility testing|sterility testing]] — so a system that prevents them is worth more than a determination that looks for them.{{r|ich_q7}} | |
| + | 40 | ||
| + | 41 | 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.{{r|usp1503}} | |
| + | 42 | ||
| 38 | == References == | 43 | == References == |
| 39 | {{reflist}} | 44 | {{reflist}} |
| ⋮ | ⋮ | ||
| 41 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 46 | <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> | 47 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| + | 48 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 43 | 49 | ||
| 44 | == See also == | 50 | == See also == |
| ⋮ | ⋮ | ||
| 47 | * [[Lot traceability]] | 53 | * [[Lot traceability]] |
| 48 | * [[Certificate of analysis]] | 54 | * [[Certificate of analysis]] |
| + | 55 | * [[Contract development and manufacturing organisation]] | |
| 49 | 56 | ||
| 50 | {{DEFAULTSORT:Good manufacturing practice}} | 57 | {{DEFAULTSORT:Good manufacturing practice}} |