Emerich Grassinger, Haupt Pharma Wülfing
Armin Groh, CSL Behring
Dr Reto Theiß, Merck
Dr Thomas Storm, Novartis Pharma
Testing active pharmaceutical ingredients and excipients is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the starting materials are released only after their quality was judged as satisfactory. This GMP Education Course about the incoming goods control of APIs and excipients will give you a comprehensive overview of the specific tasks and questions of the „starting materials lab“ and show you real-life solutions and answers.
This course will deal among others with the following questions:
- Who is responsible for the release or rejection of starting materials?
- How can the incoming goods lab be organised efficiently?
- Which SOPs are necessary?
- In which cases can test results be taken over from the supplier‘s certificate of analysis?
- Do all test items of a pharmacopoeial monograph have to be analysed?
- Are the pharmacopoeial monographs similar, or must different tests be conducted for PhEur, USP and JP?
- Can a pharmacopoeial test method be replaced by an alternative test method? Does this require a variation application?
It is the aim of this GMP Education Course to give answers to these and many other important questions relating to the testing of APIs and excipients and to serve as a forum for an intensive experience exchange.
This Education Course is directed at all those employees from quality control units in the pharmaceutical industry (including heads of quality control and laboratory managers) who are competent or responsible for sampling, testing and release of the starting materials used (= APIs and excipients).
This course is also of interest to personnel from quality assurance and to those employees from API and excipient manufacturers who want to inform themselves about the requirements of the pharmaceutical industry on the testing of these starting materials.
Regulatory Requirements for APIs and Excipients
Current GMP Requirements for APIs, Excipients and Drug Products
- Definition of APIs and excipients
- EU Requirements
- FDA Requirements, e.g. FDA Draft Guidance “Drug Product”
- Common Technical Document (CTD)
- Certification Procedures: EDQM Certificate of Suitability, Active Substance Master File, US-Drug Master File
- Quality Standard: How to discern a good starting material from a bad one?
- New requirements for excipients
- Relevant ICH guidelines
- EU regulations for Drug Products and API
- GMP for excipients – current expectations
- IPEC (International Pharmaceutical Excipients Council) Guideline for excipients
- Upcoming EU GMP regulation for excipients
- GMP aspects of supplier/manufacturer qualification
- 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 background
- Pharmacopoeial institutions – Ph.Eur., USP/NF, JP
- Implementation of pharmacopoeial monographs in your laboratory
- Multi-compendial testing
- Validation of pharmacopoeial testing methods
- New USP General Chapter <1226> Verification of Compendial Methods
Reduced Testing of Supplied APIs and Excipients
- Regulatory requirements
- Are the requirements the same for active and excipients?
- Sampling plans
- Rational for representative sample and risk analysis
- GMP-compliant documentation of sampling operations
- Practical examples
- 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
NIR (Near InfraRed Spectroscopy) for an Efficient
- 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)
- CAPA process
- Measurement system analysis
- Control of Raw Materials
- A short introduction to NIR Spectroscopy
- NIR as a pharmacopoeial monograph
- NIR for single container identification
- Costs vs. benefit
- NIR vs. ATR
WORKSHOP I Sampling
- Examples for generating sample procedures
- Risk assessment and Rational for representative sampling
- Calculating different optimizations (reduced sampling, reduced testing, economic order size)
WORKSHOP II Reduced Testing
Apart from any guidance, it is still much up to the manufacturer to decide which APIs and which excipients might be subject of a reduced testing procedure. Since the quality of the substance has to be assured without compromise, multiple factors must be considered before the full testing of every single batch can be reduced. It is the aim of this workshop to exchange information about different approaches and to discuss their advantages and disadvantages respectively considering the actual guidance as well as their practicability.