Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ... Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
ICH Q11 – Development & Manufacture ofDrug SubstancesControl strategy –what information tosubmit• Description of Manufacturing Process & Process Controls(3.2.S.2.2)• Control of Materials (3.2.S.2.3)• Control of Critical Steps & Intermediates (3.2.S.2.4)• Container Closure System (3.2.S.6)• Control of Drug Substance (3.2.S.4)Example of presentation of an overview of this information forNCE & biotech substances is provided© 2011 ICH 16
ICH Q11 – Development & Manufacture ofDrug SubstancesProcess validation/Evaluation• High level overview of approaches to PV• Includes optionality for ‘traditional 3 batch’ approach andcontinuous process verification approach described in Q8.• All manufacturing processes to be validated prior to productcommercialisation• Differences in data requirements at time of MAsubmission/approval depending on molecularcomplexity/characterisation (NCE v biotech) and depending onnature of process ( e.g aseptic processing)© 2011 ICH 17
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ICH <strong>Q11</strong> – <strong>Development</strong> & Manufacture <strong>of</strong>Drug SubstancesProcess validation/Evaluation• High level overview <strong>of</strong> approaches to PV• Includes optionality for ‘traditional 3 batch’ approach andcontinuous process verification approach described in Q8.• All manufacturing processes to be validated prior to productcommercialisation• Differences in data requirements at time <strong>of</strong> MAsubmission/approval depending on molecularcomplexity/characterisation (NCE v biotech) and depending onnature <strong>of</strong> process ( e.g aseptic processing)© 2011 ICH 17
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