Live Online Training: Ph. Eur., USP and other Pharmacopoeias - Dealing with different compendial methods - Im Auftrag der ECA Academy

Name: Live Online Training: Ph. Eur., USP and other Pharmacopoeias - Dealing with different compendial methods - Im Auftrag der ECA Academy
Start: 2020-09-22
End: 2020-09-22
Location: Live Online Training: Ph. Eur., USP and other Pharmacopoeias - Dealing with different compendial methods - Im Auftrag der ECA Academy

22/23 September 2020

Seminar Nr. 18308

Note: All times mentioned are CEST.

Unser Seminarservice

Kosten

Für dieses Online Seminar ist leider keine Aufzeichnung verfügbar. Haben Sie jedoch Interesse, an einem kommenden Live Online Termin dieses Seminars teilzunehmen? Oder wünschen Sie eine individuelle Beratung zu unserem Schulungsangebot? Dann nutzen Sie einfach das folgende Kontaktformular, um uns Ihre Anfrage zu senden.

Anfrage senden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Raphael Bar, BR Consulting, formerly with Teva, Israel
Dr Bernd Renger, Member of the Analytical QC Working Group of the ECA Foundation
Dr Ulrich Rose, EDQM, France

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.

This Education Course will discuss these issues and provides support in order to successfully deal with compendial methods and their differences.

Hintergrund

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 38 countries and the 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?

Zielgruppe

This Education Course addresses employees and managers from Quality Control Labs. It also addresses colleagues working in Quality Assurance and Regulatory Affairs department.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

Programme Day 1

09.00 – 09.15 h Welcome and Introduction

Session 1: Introduction to Pharmacopoeial Testing

09.15 – 10.15 h

Structure, General Methods and challenges of Ph. Eur.

10.15 – 11.00 h

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 European Pharmacopoeia
Structure of Ph. Eur. monographs
What the Pharmacopoeia does not say about a procedure
Dietary Supplements, API and CEP of Ph. Eur.
Mechanisms of harmonisation between Pharmacopoeias

11.00 – 11.15 h Coffee break

11.15 – 12.15 h

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 Practices

12.15 – 12.45 h Q&A Session 1

12.45 – 13.45 h Lunch break

Session 2: Important Monographs: Harmonisation, Differences, Solutions

13.45 – 14.45 h

Pharmacopoeial policy of impurities testing

Which impurities are controlled?
Analytical techniques and general texts/monographs
Control of organic impurities
What about validation?

14.45 – 15.30 h

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
Computerized data systems in laboratory
Examples: Qualification of HPLC and analytical balances

15.30 – 15.45 h Coffee Break

15.45 – 16.30 h

Life cycle approach to compendial methods

Draft USP chapter <1220> & Measurement Uncertainty
USP Chapters <1224>, <1225>, <1226>
Analytical Target Profile and Analytical Control Strategy
ICH Q2(R2) Revision
ICH Q14 Analytical Procedure Development

16.30 – 17.00 h Q&A Session 2

Programme Day 2

Session 3: Dealing with testing challenges

08.30 – 09.15 h

General Notices – Definitions and Requirements

Use of alternative procedures & interchangeable methods
Waivers to the obligation to perform all tests
Scope of general monographs
Definitions

09.15 – 10.15 h

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

10.15 – 10.30 h Coffee Break

10.30 – 11.30 h

Verification of Compendial 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
ISO 17025 requirements for method verification
Documentation of procedure verification

11.30 – 12.00 h Q&A Session 3

12.00 – 13.00 h Lunch Break

13.00 – 14.00 h

Multicompendial Testing Strategies

Divergent and conflicting pharmacopoeial requirements
CDER’s MAPP 5310.7 “Acceptability of Standards from Alternative Compendia”
How to proceed in case of missing harmonization?
Full Testing, Worst Case Testing, Alternative Testing
How to proof equivalence?

14.00 – 14.45 h

Case Studies: Meeting Challenges of Pharmacopoeial Compliance

14.45 – 15.00 h Coffee Break

15.00 – 16.00 h

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)

16.00 – 16.30 h Q&A Session 4 / End of the course

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