Shanghai Sigma-Audley New Material Technology: difference between revisions
Diff·revision 57 → 58·12:16, 17 Nov 2025
Difference between revision 57 and revision 58 of Shanghai Sigma-Audley New Material Technology. 3 lines changed; the page grew by 642 bytes.
| Revision 57 — 07:38, 7 Nov 2025 DrTitration (talk) split overlong sentence 11,769 bytes ±0 | Revision 58 — 12:16, 17 Nov 2025 LeanMassLars (talk) add figure 12,411 bytes +642 | ||
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| 82 | What is '''not''' available is independent coverage in a source unconnected with the organisation or its customers. That gap is characteristic of the sector rather than of this entity, and it constrains what a neutral article can say: capability, capacity, manufacturing arrangements and quality systems are not established here, and statements about them appear only as attributed claims.{{r|selfpub}} | 82 | What is '''not''' available is independent coverage in a source unconnected with the organisation or its customers. That gap is characteristic of the sector rather than of this entity, and it constrains what a neutral article can say: capability, capacity, manufacturing arrangements and quality systems are not established here, and statements about them appear only as attributed claims.{{r|selfpub}} |
| 83 | 83 | ||
| + | 84 | Two frameworks are named in this article only to say what has ''not'' been established against them: a quality-system claim is not a fact until assessed against the applicable good-manufacturing-practice framework,{{r|gmp}} and a testing laboratory's competence is a matter of accreditation to a recognised standard rather than of self-description.{{r|iso17025}} Neither assessment is available here for this organisation or for any other covered on this wiki. | |
| + | 85 | ||
| 84 | == References == | 86 | == References == |
| 85 | {{reflist}} | 87 | {{reflist}} |
| ⋮ | ⋮ | ||
| 89 | <ref name="tally">PeptidePedia reception tally (self-reported submissions; '''weak evidence''' — see [[Project:Sourcing guidelines]]). Self-selected sample; period and count stated at each point of use.</ref> | 91 | <ref name="tally">PeptidePedia reception tally (self-reported submissions; '''weak evidence''' — see [[Project:Sourcing guidelines]]). Self-selected sample; period and count stated at each point of use.</ref> |
| 90 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> | 92 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> |
| + | 93 | <ref name="iso17025">ISO/IEC 17025:2017, ''General requirements for the competence of testing and calibration laboratories''. International Organization for Standardization.</ref> | |
| 91 | <ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref> | 94 | <ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref> |
| 92 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a GMP claim is assessed.</ref> | 95 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a GMP claim is assessed.</ref> |