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
- 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)
- 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
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