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AUClast ☆ 2012-05-04 12:59 (5151 d 08:49 ago) Posting: # 8512 Views: 2,772 |
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The current EMA guidance on bioequivalence requires that the bioanalytical part of bioequivalence trials should be performed in accordance with the principle of GLP. I have recently seen a bioanalytical report for a BE study where only GCP compliance was stated. The justification was that according to the new EMA guidances "Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples" and to the EMA "Guidance on bioanalytical method validation" now only GCP compliance in needed and no declaration on GLP principle compliance is needed any more. Do you agree on this interpretation? Thank you Edit: Documents linked. [Helmut] — AUClast |
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Ohlbe ★★★ France, 2012-05-04 13:19 (5151 d 08:28 ago) @ AUClast Posting: # 8513 Views: 2,282 |
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Dear AUClast, ❝ Do you agree on this interpretation ? What I've heard EU regulators say is that some of the Member States (particularly UK) considered that GLP compliance was not sufficient when analysing clinical trial samples, and that GCP should be followed too, even at a lab. The UK also always had a rather strict approach to the scope of GLP, compared to some other Member States. This was the main reason for developing the recent EU Reflection Paper, which is based on a MHRA document: basically they put in a single document the relevant parts of GCP and of GLP. The wording in the EU BMV guideline is a compromise. I think some of the Member States will stick to the paragraph in the BE guideline asking for GLP compliance when analysing BE trial samples, in addition to GCP. It would be safer to continue to have a declaration on GLP compliance in the report. After all, the BMV guideline does not say explicitly that no claim of GLP compliance is needed/expected  Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz