Learning objectives
Understand & interpret the ICH Quality guidelines, CTD format, regulatory submissions w.r.t API - CEPs, ASMFs, USDMFs, WHO, Japan, Health Canada submissions
Eligibility
B.Sc/ M.Sc/ B.Pharma/M.Pharma/ Working professionals
Syllabus
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Section 1: Indian pharmaceutical industry
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- Orientation session 52 minutes
- Manufacturing process flow API 66 minutes
- Manufacturing process flow Formulation 75 minutes
- Indian pharma industry overview
- Section 2: Regulatory affairs
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- Regulatory Affairs 53 minutes
- Section 3: Insight to ICH Quality guidelines & ICH M4 Q CTD format
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- ICH introduction 97 minutes
- Chromatographic terms 75 minutes
- ICH Q1A - Stability 140 minutes
- ICH Q1 B, D & E 117 minutes
- ICH Q2 Analytical Validation 137 minutes
- ICH Q3A Impurities in drug substances 130 minutes
- ICH Q3B Impurities in drug product 94 minutes
- ICH Q3C Residual solvents 55 minutes
- ICH Q3D Elemental impurities 105 minutes
- ICH Q6 Specifications 115 minutes
- ICH M4Q CTD format 45 minutes
- Section 4: Requirements of USFDA
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- Requirements of USFDA 133 minutes
- Section 5: DMF preparation in CTD format
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- Terminology, Table of contents, S.1,S.2, APISM, ICHQ11 reference 133 minutes
- S.3, S.4, S.5 80 mins
- S.6, S.7 35 minutes
- Section 6: Regulatory submission to US
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- USDMF submissions 90 minutes
- Section 7: Regulatory submission to Europe
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- CEP submissions 150 minutes
- CEP submissions contd 80 minutes
- Genotoxic impurities 77 minutes
- ASMF submissions 17 minutes
- Section 8: Regulatory submission to other agencies
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Video session on WHO submissions uploaded. You may refer the self-explanatory PDF notes for Japan & Health Canada submissions.
- API registration with WHO 35 minutes
- Japan submissions
- Health Canada submissions
- Section 9: Additional topics
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- Change control, Changes to DMF 53 minutes