Ph. Eur., USP and other Pharmacopoeias - Online Training Recording
Dealing with different compendial methods
Course No. 22684
Speakers
Dr. Raphael Bar
BR Consulting
Dr Ulrich Rose
Straßburg
Dr Lance Smallshaw
UCB Biopharma SRL
Target Group
This Live Online Training addresses employees and managers from Quality Control Labs. It also addresses colleagues working in Quality Assurance and Regulatory Affairs department.
Objectives
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?
Programme
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
Further Information
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.
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.
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