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Web3.2.S.4.4 Batch Analyses 3.2.S.4. Control of Drug Substance [{Drug Substance Name}, {Manufacturer}] 1 4. BATCH ANALYSES [{DRUG SUBSTANCE NAME}, {MANUFACTURER}] Description of batches and results of batch analyses should be provided. These Batches include lots used in safety, efficacy, BA/BE, and primary … http://www.triphasepharmasolutions.com/Resources/3.2.S.2.4%20MANUFACTURE%20(Control%20of%20Critical%20Steps%20and%20Intermediates).pdf Webactive substance should be laid down unambiguously in the MA dossier (NtA CTD format section 3.2.S.4.1 and 3.2.S.4.2 or old human/veterinary NtA format part IIC1). The Applicant/MA holder should include a copy of the AP in the MA dossier (NtA CTD format section 3.2.S or NtA old human/veterinary format part IIC1). The version of the AP in the tic tac candy price