Quality Control of Starting Materials (APIs and Excipients)
18/19 March 2026, Vienna, Austria
Course No. 22168
Speakers
Dr Reto Theiß
Merck Healthcare
Emerich Grassinger
Takeda
Veronika Käser
Merck Healthcare
Target Group
This GMP 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.
Objectives
It is the aim of this GMP Education Course 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.
Background
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.
Programme
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
Pharmacopoeias
Regulatory Background
Pharmacopoeial institutions – Ph.Eur., USP/NF, JP
CEPs
Implementation of pharmacopoeial monographs in your laboratory
Multi-compendial testing
Validation of pharmacopoeial testing Methods
USP General Chapter <1226> Verification of Compendial Methods
Laboratory Organisation
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
Training
GMP-compliant documentation of sampling operations
Practical examples
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)
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
WORKSHOP II Reduced Testing
Different approaches for reduced testing
Advantages and disadvantages
Considerations of actual guidances and their practicability.
Analytical Methods
Use and validation of non-compendial methods
How to prove comparability?
Advantages of instrumental methods versus visual Methods
Handling of deviations (Out-of-Specification results and complaints)
Measurement system Analysis
Documentation
Retests
Further Information
Venue Doubletree by Hilton Vienna Schönbrunn Schlossallee 8 1140 Vienna Austria +43 1 / 89 110 info@doubletree-schonbrunn.at
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) ECA Members € 1,890.- APIC Members € 1,990.- Non-ECA Members € 2,090.- EU GMP Inspectorates € 1,045.- The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Social Event On the evening of the first course day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
