ECA-PhEur-USP-and-other-Pharmacopoeias-Live-Online-Training - Live Online Training 05/06 November 2025

Sep 8, 2026

Live Online Training addresses how to handle pharmacopoeial methods and their differences across Ph. Eur., USP and additional pharmacopoeias worldwide, including Japan, China, India and the International Pharmacopoeia. The programme explains structures and enforcement, harmonisation and legal status, and how to apply alternative procedures, interchangeable methods, and reference standards. It also covers testing of organic impurities, ICH Q3D implementation, verification and equivalence of compendial procedures, multicompendial testing strategies, and analytical instrument qualification (DQ, IQ, OQ, PQ).

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages4

Reading Time10 min

AccessFree to download

Highlights

Structure of Ph. Eur. and USP and enforcement

Additional pharmacopoeias worldwide

Harmonisation and testing strategies

Programme Day 1

Session 1: Introduction to Pharmacopoeial Testing

Session 2: Important Monographs and Harmonisation

Programme Day 2

Session 3: Dealing with Testing Challenges

Reference Standards: Similarities and Differences

Speakers Dr Raphael Bar BR Consulting, formerly with Teva Dr Ulrich Rose Former Deputy Head of the European Pharmacopoeia Department, EDQM Dr Lance Smallshaw UCB, Belgium GMP Certification Programme Certified Quality Control Manager Ph. Eur., USP and other Pharmacopoeias Dealing with different compendial methods Live Online Training on 05/06 November 2025 Highlights 􀂃 Structure of Ph. Eur. and USP and their enforcement 􀂃 Additional Pharmacopoeias around the world – Japan, China, India, Int. Ph. (WHO) 􀂃 Harmonisation of Ph. Eur., USP, JP 􀂃 Ph. Eur., USP Testing for Organic Impurities 􀂃 Implementation of ICH Q3D – differences and similarities 􀂃 Analytical Instrument Qualification according to Ph. Eur. and USP 􀂃 Reference Standards-similarities and differences 􀂃 Verification of Compendial Procedures 􀂃 Alternative methods to pharmacopoeial methods 􀂃 Equivalence testing of two methods 􀂃 Multicompendial Testing Strategies • Including Workshops • Implementation & Comparability of Pharmacopoeial Procedures • Revised harmonised chapter on chromatographic separation techniques Programme 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. This Live Online Training will discuss these issues and provides support in order to successfully deal with compendial methods and their differences. Background 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](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 PDGharmonisation 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? Target Audience This Live Online Training addresses employees and managers from Quality Control Labs. It also addresses colleagues working in Quality Assurance and Regulatory Affairs department. This Live Online Training Course is recognized for the GMP/ GDP Certification Scheme Building on your education the ECA GMP/GDP certification programmes provide you with the appropriate supplement to acquire this qualification. The Live Online Training is the first element foryour additional certification. Simply choose any three courses within the programme according to your professional interest. Your certificate is then valid for two years. To renew it, you can pick any training from the ECA courses and conferences list within that two-years period – allowing you to broaden your knowledge in GMP and GDP compliance. Please find more information at www. [gmp-certification.org](gmp-certification.org) Programme Day 1 Session 1: Introduction to Pharmacopoeial Testing Structure, General Methods & Challenges of Ph. Eur./ Structure, Monographs and Activities of USP | 􀂃 Structure of Ph. Eur. and USP
􀂃 Meeting Pharmacopoeial stan

FAQs

How does the training describe the structure and enforcement of Ph. Eur. and USP?

It covers the structure of Ph. Eur. and USP, including how standards are met and how pharmacopoeial designation is applied, plus the USP approach of single testing.

What topics are included under harmonisation and differences between pharmacopoeias?

The course addresses harmonisation efforts and mechanisms, revised harmonised general chapters on chromatography, and discusses similarities and differences through examples such as Ph. Eur., JP, Chinese, Russian and International Pharmacopoeia.

How does the programme approach alternative procedures, equivalence, and multicompendial testing strategies?

It explains how to use alternative and interchangeable methods, allowed exceptions and waivers, how to prove equivalence, and how to design multicompendial testing strategies across methods.

Sep 8, 2026

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