7/8 February 2023
Emerich Grassinger, Takeda, Austria
Veronika Käser, Merck, Germany
Dr Reto Theis, Merck, Germany
It is the aim of this Live Online Training to give practical oriented advice regarding the testing of APIs and excipients. You will learn
- who is responsible for the release or rejection of starting materials,
- how the incoming goods lab can be organised efficiently,
- which SOPs are necessary,
- in which cases test results can be taken over from the supplier’s certificate of analysis,
- whether or not all test items of a pharmacopoeial monograph have to be analysed,
- whether the pharmacopoeial monographs are similar and in which cases different tests must be conducted for Ph.Eur., USP and JP,
- when a pharmacopoeial test method can be replaced by an alternative test method and in which cases this requires a variation application.
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 main goal can also be achieved by applying reduced sampling/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.
However, 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.
This Live Online Training 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
- 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.
We use Webex Events for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.