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shujak1 ☆ 2009-03-05 20:55 (6322 d 05:16 ago) Posting: # 3326 Views: 3,197 |
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If a Bioanalytical Validation or Study SOP is revised and significant changes are done in the revised version,how it can be handled for ongoing projects as already executed projects will be done as per old version of these SOPs.And how and where this shall be documented if even after effective date also one is following the earlier version.Whether this will be considered as a deviation? |
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babun14 ☆ 2009-03-06 08:06 (6321 d 18:05 ago) @ shujak1 Posting: # 3329 Views: 2,521 |
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Hi sujak1, During method validation you must be preparing method validation protocol according to your applicable SOP. If the protocol you ae praparing is as per the old SOP then you don't have to file deviation even new SOP comes to place.However, from the next project onwards, you have to follow your new SOP. regards Bani |
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