SPECIFICATIONS AND CONTROL TESTS ON THE …
85 _____ 3AQ11a SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Note for guidance concerning the application …
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Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
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