Active pharmaceutical ingredient: difference between revisions
Diff·revision 20 → 21·08:07, 2 Oct 2025
Difference between revision 20 and revision 21 of Active pharmaceutical ingredient. 2 lines changed; the page grew by 214 bytes.
| Revision 20 — 09:52, 6 Sep 2025 Compounding_Cate (talk) state that a GMP claim is not a fact until assessed 4,355 bytes ±0 | Revision 21 — 08:07, 2 Oct 2025 PurityClaimPia (talk) add the year the guidance was issued 4,569 bytes +214 | ||
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| 39 | This is why claims of the form "made on the same line as pharmaceutical material" are hard to evaluate. They may be true and yet say nothing about whether the batch in question was made under the same controls, since GMP applies to a process and its records rather than to a room. | 39 | This is why claims of the form "made on the same line as pharmaceutical material" are hard to evaluate. They may be true and yet say nothing about whether the batch in question was made under the same controls, since GMP applies to a process and its records rather than to a room. |
| 40 | 40 | ||
| + | 41 | For a purchaser reading a certificate, the useful question is unchanged: what does this document report, and against what specification? A grade name answers neither. See [[Certificate of analysis]].{{r|usp1503}} | |
| + | 42 | ||
| 41 | == References == | 43 | == References == |
| 42 | {{reflist}} | 44 | {{reflist}} |