Animal PK Sample Analysis [Regulatives / Guidelines]

posted by riteshsrmc  – India, 2013-10-28 08:51 (4625 d 05:47 ago) – Posting: # 11787
Views: 2,604

Hi,

Can you pl. someone respond to the following query?

If Pre-clinical studies (Life Phase) being conducted at CRO (GLP Certified) and PK samples from that CRO is being analyzed at a Bioanalytical CRO (Not GLP Certified but comply with GLP). So
  1. Whether It would be acceptable by Regulator(s). Since Bioanalytical CRO does not have GLP certification?
  2. As far as I beleieved that Bioanalytical CRO does nor comes under National GLP compliance Programme? (Is it right)?
  3. Whether Bioanalytical CRO can be audited by National GLP compliance Programme?
Early response would be highly appreciate.

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