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

More documents

Recommendations

Info

ICH Q11 – Development & Manufacture ofDrug SubstancesGlossary• Platform Manufacturingo The approach of developing a production strategy for anew drug starting from manufacturing processes similar tothose used by the same applicant to manufacture otherdrugs of the same type (e.g as in production ofmonoclonal antibodies using predefined host cell, cellculture and purification process, for which there existsconsiderable experience)© 2011 ICH 22
ICH Q11 – Development & Manufacture ofDrug SubstancesNext steps• Public Consultation Periodso USAo Japano EU• Timetable to Step 4• Implementationo See IWG Q&Ao No new regulatory requirementso Optionality in approaches to manufacturing processdevelopment© 2011 ICH 23
Page 1 and 2: ICH Q11 - Development &manufacture
Page 3 and 4: ICH Q11 - Development & Manufacture
Page 21: ICH Q11 - Development & Manufacture

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

Create successful ePaper yourself

Delete template?

Save as template?