The European Active Substance Master File Procedure – An Introduction
- Regulatory background and Scope
- The revised ASMF guideline
- Open and closed parts – points to consider
- Comparison of ASMF and CEP procedure
Drug Master File Procedures in the US
- Types of Drug Master Files
- Drug Master Files under GDUFA
- Submissions of DMFs
- Holder obligations
- Maintenance of Drug Master Files
- US vs EU DMF – differences in the procedure
How to Document Drug Substance Stability
- Stability Guidelines
- Stability Testing of new drug substances and drug products
- Storage Conditions
- Bracketing and Matrixing Designs
- Stability data from new drug dosage forms
- How to document evaluation of stability data
- Optimising the submission
Residual Solvents and Impurities: Synthesis Derived Impurities, Metals and Genotoxic Impurities
- Guidelines
- Impact of the new guidelines ICH Q3D and ICH M7
- Sources of Impurities
- Setting and justification of specifications
- Residual solvents, solvent classes
- Content and scope of data – documentation requirements
- Frequent mistakes
Post Approval Changes in the US
- Post approval activities
- Reporting requirements to the FDA (CBE 0, CBE 30, Annual Report)
- Post approval commitments and post approval reporting requirements
- Risk evaluation and mitigation strategies (REMS)
Handling Changes in European Drug Master Files
- Why is there a need for changes
- Types of changes
- How to communicate with the MA holders and how to get feed back
- Differences between ASMF and CEP
- When to implement a specific change
- Version management of the ASMF
Requirements of the Drug Master File Procedure in Japan
- Regulatory procedures in Japan:
- Site accreditation
- GMP paper based inspection
- Drug Master File
- Drug Master File format
- Specific points to consider for the J-DMF
- Communication with the Japanese authorities
Changes and Maintenance of Japanese Drug Master Files
- Change procedures and communication with the Japanese authority
- Types of changes
- Notification of changes
Comparison of the CEP and ASMF Procedure
- The certification scheme of the Ph.Eur.
- Advantages and disadvantages of the CEP procedure compared to the ASMF procedure
- Handling of variations in the CEP procedure
- Countries accepting CEPs
Workshop: Managing Changes in Drug Master Files - Case Studies