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ramya ☆ 2010-03-03 11:07 (5947 d 05:49 ago) Posting: # 4851 Views: 6,419 |
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Dear All, I am ramya,working in QA. i have few doubts about, qa reviewing the pre Method validation. when the method is developed, should qa has to approve the development for method validation procedure to begin? or its analyst discretion to decide? regards, ramya |
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bharat ☆ India, 2010-03-17 08:44 (5933 d 08:11 ago) @ ramya Posting: # 4924 Views: 5,141 |
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Dear ramya Its depends on your Internal SOP. I will suggest that it will be good if it will approved by QA as it will be authenticated. There is not such guideline for this Regards Bharat Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Dr_Dan ★★ Germany, 2010-03-17 12:05 (5933 d 04:51 ago) @ bharat Posting: # 4927 Views: 5,101 |
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Dear all Bharat is right, it depends on your internal SOP. In my opinion the method development does not need to be QA'd. The method SOP has to be QA'd as well as the method validation. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz