RE: pharmacopoeial method Contribution from Roy Cowell written on 9/10/2008 at 13:40
Original contribution: pharmacopeial method written by Tareq taha on 9/8/2008 at 23:09) The answer to the original question lies in laboratory competence, and sound judgement of what is required from the particular assay. The keys to laboratory competence are to be found within the pharmacopoeial monographs related to analysis and instrumental techniques. Equipment validation, laboratory techniques, and system suitability testing are paramount. Judgement of assay suitability has to be derived from the agreed specification, although specification setting should be an iterative process alongside method development and validation. Requirements for laboratory testing are described in the pharmacopoeia. From a regulatory viewpoint laboratory competence is built on these foundations.
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