Comments on: Pre-Execution Approval of Validation Test Scripts – What To Look Out For! http://www.askaboutvalidation.com/pre-execution-approval-of-validation-test-scripts-what-to-look-out-for/ The World's No.1 Validation Forum Wed, 15 May 2013 21:48:02 +0000 hourly 1 http://wordpress.org/?v=3.5.1 By: debbie http://www.askaboutvalidation.com/pre-execution-approval-of-validation-test-scripts-what-to-look-out-for/#comment-4051 debbie Fri, 18 Jan 2013 14:12:26 +0000 http://www.askaboutvalidation.com/?p=52238#comment-4051 Is there a predicate rule that calls for pre execution approval and post execution approval of test scripts , is it just good testing practice to have this done? This is functional testing carried out independant of validation.

]]> By: gokeeffe http://www.askaboutvalidation.com/pre-execution-approval-of-validation-test-scripts-what-to-look-out-for/#comment-1789 gokeeffe Tue, 23 Oct 2012 07:40:54 +0000 http://www.askaboutvalidation.com/?p=52238#comment-1789 The requirement for Quality unit “preapproval” of tests really depends on whether the protocol is “qualification” (IQ/OQ) or process validation (PQ/PV). IQ and OQ do not require Q-unit preapproval (or even exist as such) per ASTM E 2500-07. That ASTM standard was driven by ISPE and is referenced by the FDA in the Process Validation Guideline as a “useful” guidance for conducting “Stage 2a” (facilities and equipment verified as fit for use). There are of course prerequisites – engineers can’t just run off and do tests. I highly recommend the ASTM (something like $35 off their website) and several ISPE guides on the subject.

PQ is really process validation on a unit operation scale, and of course, per the FDA’s longstanding guidance, Quality unit preapproval of process validation is an expectation. For both PQs and PVs, process SMEs, including the Quality unit, should preapprove sampling plans, testing plans, test methods and acceptance criteria. And of course post-approve the results and conclusions that result.
Posted by Dave Dolgin

]]> By: VB http://www.askaboutvalidation.com/pre-execution-approval-of-validation-test-scripts-what-to-look-out-for/#comment-1685 VB Tue, 16 Oct 2012 13:01:16 +0000 http://www.askaboutvalidation.com/?p=52238#comment-1685 Very good article. We also check if all the verification steps direct to include screenprints as attachments

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