RE: INTEGRITY TESTING Contribution from JD Mallet written on 9/29/2008 at 09:24
Original contribution: INTEGRITY TESTING written by Archana Verma on 9/28/2008 at 14:15) Dear Archana,
You are right integrity testing is required in any GMP guideline. For US guide (cGMP) combination of the requirements contained in 21CFR and in Aseptic Guidance is clear about the need to test the integrity of containers either ampoules or vials. According to EU-GMP, 100% of sealed containers should be tested for integrity. According to WHO-GMP integrity can be tested on samples, which is different.
As a summary, depending on the size of your batch to be tested for integrity, you may test it in the R&D lab if it is compliant with GMPs. Otherwise, no. However, because the testing for integrity should probably be done on 100% of the production it is unlikely that such operation may be burdensome would be satisfactorily carried out in R&D. But, at the end, it's up to you (QA) to decide !
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