Dr Reto Theiß
Merck Healthcare
Referierende
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
- 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
Zielgruppe
- 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
Zielsetzung
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:
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
Dr Markus Funk
Programm
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
Weitere Informationen
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.
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.
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.
Contacts
Questions regarding content:
Herr Dr Markus Funk +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Herr Niklaus Thiel +49 6221 84 44-43, thiel@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 2 March 2027, 09:00-17:00 h
Wed, 3 March 2027, 09:00-17:00 h
All times mentioned are CET.
Wed, 3 March 2027, 09:00-17:00 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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