Regulatory Requirements for APIs and Excipients
- Definition of APIs and excipients
- EU requirements
- FDA requirements
- Common Technical Document (CTD)
- Certification Procedures:
- EDQM Certificate of Suitability
- Active Substance Master File
- US - Drug Master File
- Quality Standards: How to discern a good starting material from a bad one?
- New requirements for excipients
Current GMP Requirements for APIs, Excipients and Drug Products
- Relevant ICH guidelines
- EU regulations for Drug Products and APIs
- GMP for excipients – current expectations
- IPEC (International Pharmaceutical Excipients Council) Guideline for excipients
- EU GMP regulation for excipients
- GMP aspects of supplier/manufacturer qualification
- Challenge: risk assessment for excipients
- Regulatory background
- Pharmacopoeial institutions – Ph.Eur., USP/NF, JP
- Implementation of pharmacopoeial monographs in your laboratory
- Multi-compendial testing
- Validation of pharmacopoeial testing methods
- USP General Chapter <1226> Verification of Compendial Methods
- Role of the raw materials laboratory within the pharmaceutical supply chain
- Optimization of the analytical laboratory with respect to costs, time and resources (economic order size, costs of analysis vs stock keeping costs, reduced sampling and reduced testing, ABC analysis)
Sampling of Incoming APIs and Excipients
- Regulatory requirements
- Reduced Testing
- Sampling plans
- Rational for representative sample and risk analysis
- GMP-compliant documentation of sampling operations
- Practical examples
- Examples for generating sample procedures
- Risk assessment and Rational for representative sampling
- Calculating different optimizations (reduced sampling, reduced testing, economic order size)
Reduced Testing of Supplied APIs and Excipients
- What guidance is available on reduced QC testing?
- EU and FDA expectations?
- Supplier qualification as a prerequisite
- Other information required before you start reducing
- Can APIs and excipients be covered within the same approach?
- Who is in the driver seat, who must be involved?
- Practical execution
- Different approaches for reduced testing
- Advantages and disadvantages
- Considerations of actual guidances and their practicability.
- Use and validation of non-compendial methods
- How to proof comparability?
- Advantages of instrumental methods versus visual methods
- Handling of deviations (Out-of-Specification results and complaints)
- Measurement system analysis
Q&A sessions will ensure interaction and that your questions will be answered.