Certificate of analysis: difference between revisions
Diff·revision 5 → 6·04:13, 22 Sep 2024
Difference between revision 5 and revision 6 of Certificate of analysis. 3 lines changed; the page grew by 614 bytes.
| Revision 5 — 09:54, 13 Sep 2024 AnalyticalAnnie (talk) add the second-opinion point: two services, one lot, is a stronger record 2,872 bytes ±0 | Revision 6 — 04:13, 22 Sep 2024 BatchNumberBede (talk) give the fields a compendially-complete certificate would carry 3,486 bytes +614 | ||
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| 20 | | Release date and signatory | When and by whom the lot was released | A signature records release, not verification | | 20 | | Release date and signatory | When and by whom the lot was released | A signature records release, not verification | |
| 21 | 21 | ||
| + | 22 | A specification is a list of tests, the analytical procedures referenced by them, and the acceptance criteria applied to the results, so a figure reported with no specification against it has not been the subject of a release decision at all.{{r|ich}} | |
| + | 23 | ||
| 22 | == References == | 24 | == References == |
| 23 | {{reflist}} | 25 | {{reflist}} |
| 24 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision. Describes the determinations that together characterise a synthetic peptide, and why purity alone does not.</ref> | 26 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision. Describes the determinations that together characterise a synthetic peptide, and why purity alone does not.</ref> |
| 25 | <ref name="iso17025">ISO/IEC 17025:2017, ''General requirements for the competence of testing and calibration laboratories''. International Organization for Standardization. The standard against which a testing laboratory's competence is assessed; self-description is not assessment against it.</ref> | 27 | <ref name="iso17025">ISO/IEC 17025:2017, ''General requirements for the competence of testing and calibration laboratories''. International Organization for Standardization. The standard against which a testing laboratory's competence is assessed; self-description is not assessment against it.</ref> |
| + | 28 | <ref name="ich">International Council for Harmonisation, ''Q6A: Specifications — Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances''. Defines a specification as a list of tests, references to analytical procedures and acceptance criteria; a result reported without one is not a release decision.</ref> | |
| 26 | 29 | ||
| 27 | {{DEFAULTSORT:Certificate of analysis}} | 30 | {{DEFAULTSORT:Certificate of analysis}} |