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 SubstancesProcess validation / Evaluation• Biotech specific aspects:o PV studies include studies at commercial scale in addition toparticular studies (e.g virus removal) conducted at small scale.o When platform manufacturing experience is utilised, thesuitability of the control strategy should be demonstrated andthe drug substance manufacturing process should beappropriately validated at the time of the marketingauthorisation application. Full scale validation studies shouldinclude data derived from the final manufacturing process andsite(s) used to produce the product to be commercialised.© 2011 ICH 18
ICH Q11 – Development & Manufacture ofDrug SubstancesWhere to submit using CTD• Quality risk management & process development• Critical Quality Attributes• Design Space• Control Strategy© 2011 ICH 19
- Page 1 and 2: ICH Q11 - Development &manufacture
- Page 3 and 4: ICH Q11 - Development & Manufacture
- Page 5 and 6: ICH Q11 - Development & Manufacture
- Page 7 and 8: ICH Q11 - Development & Manufacture
- Page 9 and 10: ICH Q11 - Development & Manufacture
- Page 11 and 12: ICH Q11 - Development & Manufacture
- Page 13 and 14: ICH Q11 - Development & Manufacture
- Page 15 and 16: ICH Q11 - Development & Manufacture
- Page 17: ICH Q11 - Development & Manufacture
- Page 21 and 22: ICH Q11 - Development & Manufacture
- Page 23 and 24: ICH Q11 - Development & Manufacture
ICH <strong>Q11</strong> – <strong>Development</strong> & Manufacture <strong>of</strong>Drug SubstancesProcess validation / Evaluation• Biotech specific aspects:o PV studies include studies at commercial scale in addition toparticular studies (e.g virus removal) conducted at small scale.o When platform manufacturing experience is utilised, thesuitability <strong>of</strong> the control strategy should be demonstrated andthe drug substance manufacturing process should beappropriately validated at the time <strong>of</strong> the marketingauthorisation application. Full scale validation studies shouldinclude data derived from the final manufacturing process andsite(s) used to produce the product to be commercialised.© 2011 ICH 18
Change language