GLP certification for Bioanalytical Lab. to conduct BA/BE studies. [Bioanalytics]

posted by ElMaestro  – Denmark, 2021-12-18 09:55 (801 d 04:24 ago) – Posting: # 22700
Views: 1,589

Hi Shreyas,

❝ As I only aware about, "As per OECD, GLP should be applied to the non-clinical safety testing of test items of pharmaceutical products".

OECD GLP was intended for that. Then some regulators thought it'd be useful to apply the same standards in bioanalysis. They can do so at will; whatever is written in the OECD document intention-wise does not per se rule out that regulators can apply the same standards outside the original scope.

❝ Does bioanalytical Lab. (for BA-BE studies) require GLP certification or to follow GLP?

If you intend to submit in Europe, then the audit criteria may be GLP, but the CRO or the lab does not need a GLP accreditation/certification. There is wording to this effect in the guideline on BE: "The bioanalytical part of bioequivalence trials should be performed in accordance with the principles of Good Laboratory Practice (GLP). However, as human bioanalytical studies fall outside the scope of GLP, the sites conducting the studies are not required to be monitored as part of a national GLP compliance programme."
So no certification necessary if you submit in EU.
Note also wording in the EU guideine for bioanalytical validation: "The validation of bioanalytical methods and the analysis of study samples for clinical trials in humans should be performed following the principles of Good Clinical Practice (GCP)".

Not ideal but there you go.

Pass or fail!

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