Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...

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ICH Q11 – Development & Manufacture ofDrug SubstancesWhat topics are covered in ICH Q11 ?• Introduction & scope• Manufacturing Process Development• Description of the Manufacturing Process & Process Controls• Selection of Starting Materials and Source Materials• Control Strategy• Process Validation/Evaluation• Where to file information in CTD• Lifecycle Management• Illustrative Examples• Glossary© 2011 ICH 8
ICH Q11 – Development & Manufacture ofDrug SubstancesManufacturing Process Development• Identifying CQA for drug substance in relation to drug producttarget product profile• Defining a suitable manufacturing process• Defining a robust control strategy to ensure process performanceand drug substance quality• Systematic evaluation, understanding and refining of themanufacturing processoUse of risk assessment tools, prior knowledge and experimentationto identify the material attributes and process parameters that canhave an effect on drug substance CQAoDetermining the functional relationships that link material attributesand process parameters to drug substance CQA© 2011 ICH 9
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