CDSCO - Guidance for Industry - Central Drugs Standard Control ...

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Guidance for Industry Central Drugs Standard Control Organization Page 48   MODULE - 3 Quality Information (Chemical, Pharmaceutical and Biological) 3.1 Table of contents for Module 3 3.2 Quality contents 3.2.S Drug substance(s): Information must be submitted for each   drug substance in the product. 3.2.S.1 General information, starting materials and raw materials 3.2.S.1.1 Trade and/or non-proprietary name(s) of the drug substance 3.2.S.1.2 Structural formula, molecular formula and relative molecular weight (if applicable) 3.2.S.1.3 Description and characterization of drug substance 3.2.S.1.4 General description and history of starting material 3.2.S.1.4.1 Strain 3.2.S.1.4.2 System of seed/master/working banks 3.2.S.1.4.3 Embryonated eggs and other cell substrates 3.2.S.1.5 General description of raw materials 3.2.S.1.6 Analytical certificates signed by the manufacturer and the applicant for registration 3.2.S.2 Manufacturing process for drug substance
Guidance for Industry Central Drugs Standard Control Organization Page 49   3.2.S.2.1 Manufacturer(s) 3.2.S.2.2 Description of manufacturing process 3.2.S.2.3 Flow diagram of manufacturing process 3.2.S.2.4 Identification of critical steps in process and control 3.2.S.2.5 Validation of manufacturing process 3.2.S.2.6 Manufacturing process development 3.2.S.2.7 Description of inactivation or detoxification process 3.2.S.2.8 3.2.S.2.9 3.2.S.2.10   Description of purification process Description of conjugation process Stabilization of active ingredient 3.2.S.2.11 Reprocessing 3.2.S.2.12 3.2.S.2.13 Filling procedure for the active ingredient, in-process controls Selection and justification of critical steps 3.2.S.2.14 Description of batch identification system 3.2.S.3 Characterization of drug substance 3.2.S.3.1 Physicochemical Characterization 3.2.S.3.2 Biological Characterization 3.2.S.3.3 Impurities (name, manufacturer) 3.2.S.4 Quality control of drug substance 3.2.S.4.1 Specifications
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  © Central Drugs Standard Contr
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