Dr. Raphael Bar
BR Consulting
Referent:innen
Dr Ulrich Rose
Straßburg
Dr Lance Smallshaw
UCB Biopharma SRL
Zielgruppe
This Live Online Training addresses employees and managers from Quality Control Labs. It also addresses colleagues working in Quality Assurance and Regulatory Affairs department.
Zielsetzung
It is important to understand the structure and the procedures of the different Pharmacopoeias. Some general chapters and the monographs of some widely used excipients have already been harmonised between the most important Pharmacopoeias, USP, Ph. Eur. and JP in the context of the Pharmacopoeial Discussion Group (PDG). But for a large number of general methods differences still exist. Therefore, some of the frequently asked questions are:
- How to use alternative procedures and interchangeable methods?
- What are the allowed exceptions to the obligation to perform all tests?
- How can multi-compendial testing strategies look like?
- How to prove equivalence?
In addition, PDG harmonisation does not include upcoming important pharmacopoeias like Indian and Chinese Pharmacopoeias.
Background
This Live Online Training will discuss these issues and provides support in order to successfully deal with compendial methods and their differences.
Pharmaceutical companies have to follow Pharmacopoeia standards in order to meet regulatory requirements. However, there is no single Pharmacopoeia which can be applied in all regions. The US FDA may enforce USP monographs which then become mandatory whereas compliance with Ph. Eur. is mandatory in 39 member states and the European Union (EU) and is applied in over 100 countries worldwide. Moreover, also other Pharmacopoeias exist in the world like the Japanese (included in the PDG harmonisation process) , Chinese, Russian or Indian Pharmacopoeias.
But what are the differences and how to deal with quality standards and test methods if products are manufactured and released for different markets?
But what are the differences and how to deal with quality standards and test methods if products are manufactured and released for different markets?
Programm
Programme Day 1
Session 1: Introduction to Pharmacopoeial Testing
Structure, General Methods and Challenges of Ph. Eur. / Structure, Monographs and Activities of USP
- Structure of Ph. Eur. and USP
- Meeting Pharmacopoeial standards and Pharmacopoeial Designation
- The USP approach: Single Testing
- Structure of USP monographs:
- modern monograph
- flexible monograph
- Structure of Ph. Eur. monographs
- What the Pharmacopoeia does not say about a procedure
Additional Pharmacopoeias around the World – Japan, China, India, Int. Ph. (WHO), BP
- Historical developments
- The development of the International Pharmacopoeia
- JP, ChP, Russian Ph., and IP – similarities and differences
- Legal status and enforcement
- WHO Good pharmacopoeial Practice
Session 2: Important Monographs: Harmonisation, Differences, Solutions
Analytical Instrument Qualification according to Ph. Eur. and USP
- USP General Chapter <1058> Analytical Instrument Qualification and Ph. Eur.
- Type of instruments and risk assessment
- Qualification steps: DQ, IQ, OQ and PQ
- Roles and responsibilities
General Texts and General Chapters
- Meaning of general texts and chapters
- Harmonisation efforts
- Recent revisions, e. g. elemental impurities and nitrosamine control
Revised Harmonised General Chapter on Chromatography (incl. Workshop)
- History and background of Ph. Eur. 2.2.46, JP <2.00>, USP <621>
- Mechanisms of harmonisation between Pharmacopoeias
- Definitions and adjustment of chromatographic conditions
- Important changes
Workshop 1: Reporting Compendial Test Results
Programme Day 2
Session 3: Dealing with testing challenges
General Notices – Definitions and Requirements
- Use of alternative procedures & interchangeable methods
- Waivers to the obligation to perform all tests
- Scope of general monographs
- Definitions
Reference Standards - Similarities and Differences
- Definitions and guidelines
- Legal status of reference standards
- Types of standards
- Establishment and use/Testing and value assignment
- Similarities and differences between pharmacopoeias
Verification / Implementation of Compendial Procedures
- USP <1226> Verification of Compendial Procedures and Ph. Eur. Chapter 5.26 Implementation of Pharmacopoeial Procedures
- Difference between Verification and Transfer of an analytical procedure
- Chemical vs microbiological procedures
- Minimal performance characteristics to be verified
- What to verify in procedures for high-level (Assay by HPLC) and low-level analytes (Impurities by HPLC and TLC)
- When procedure verification is not required
- Documentation of procedure verification
Pharmacopoeial Policy of Impurities Testing
- Which impurities are controlled?
- Analytical techniques and general texts/monographs
- Control of organic impurities
- What about Validation?
Alternative Methods to Pharmacopoeial Methods: Equivalence Testing of Two Methods
- Is a compendial procedure equivalent to an in-house validated procedure?
- Critical performance characteristics to be compared
- Plotting the results of comparative testing
- Traditional way of comparison of two procedures
- Equivalence testing with two one-sided t-test (TOST)
Multicompendial Testing Strategies
- Divergent and conflicting pharmacopoeial requirements
- How to proceed in case of missing harmonization?
- Full Testing, Worst Case Testing, Alternative Testing
- How to proof equivalence?
Workshop 2: Meeting Challenges of Pharmacopoeial Compliance
Weitere Informationen
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 (0)6221 8444 35, kuehn@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 (0)6221 84 44 51, strohwald@concept-heidelberg.de
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 (0)6221 8444 35, kuehn@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 (0)6221 84 44 51, strohwald@concept-heidelberg.de
Recording from 5/6 November 2025
Duration of Recording: 12h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Regular Fee*: | € 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"
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E-Mail: info@concept-heidelberg.de
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