Quality Control of Starting Materials (APIs and Excipients) - Live Online Training
Testing and Sampling of Incoming Active Pharmaceutical Ingredients (APIs) and Excipients
2/3 March 2027
Course No. 22939
Speakers
Dr Reto Theiß
Merck Healthcare
Emerich Grassinger
Takeda
Veronika Käser
Merck Healthcare
Participate in 2 Workshops: - Sampling - Reduced Testing
Highlights: - Current regulatory/GMP and pharmacopoeial requirements for APIs, excipients and drug products - Sampling of incoming APIs and excipients - Reduced testing of supplied APIs and excipients
Target Group
Employees from quality control units in the pharmaceutical Industry
Heads of quality control and laboratory managers
Quality assurance personnel
Employees from API and excipient manufacturers
Objectives
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 to 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.
It is the aim of this GMP Education Course to give practice-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.
Moderator Dr Markus Funk
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 API
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
Rationale 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 rationale 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
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Fees Non-ECA Members EUR 2,090 ECA Members EUR 1,890 APIC Members EUR 1,990 EU GMP Inspectorates EUR 1,045 per delegate plus VAT The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
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