CURRENT DEVELOPMENTS IN GMP COMPLIANCE
The GMP environment is subject to constant changes. For instance, Data Integrity has become a large issue throughout the last years - causing several authorities worldwide to draft and publish guidances: the US FDA in April 2016, the British MHRA in July followed by the PIC/S in August. This is just one example for the changes in the GMP world directly affecting companies in how they do business and thus management needs to be aware of.
It is the constant changes and developments like these the European GMP Conference puts on its screen every two years. And it's the conference that has thus become the industry's meeting point in terms of GMP update in Europe throughout the last years.
The main focus of this year's conference from 31st May to 1 June in Prague, Czech Republic, will be on EU GMP. However, as corporate quality systems of internationally operating companies need to cover the regulations of both regions, a harmonized approach with FDA cGMP and new developments in the US will also be in the center of attention. Alex Viehman, the current Head of the Quality Intelligence Branch at the FDA / CDER / OPQ / OS, will present the latest state of the discussion on "Quality Metrics" in the FDA as part of a "Quality Oversight" session. And - although the term does not exist in the EU GMP Guide - a European GMP inspector will provide a European perspective on the subject, in addition to the industrial view presented on this topic.
Recommendation
Berlin, Germany4/5 December 2024
Root Cause Analysis
Another session will concentrate on the current initiatives in the EU and the USA. Updates on recent EU GMP changes and practical advice for how to do business with companies that operate outside of the EU/FDA zones will be in the focus there.
A GMP theme that is also currently being intensively discussed is the one already mentioned in the beginning: Data Integrity. That's why it will be examined from both the regulatory and the industry side - specifically from the British MHRA, which has published its own Guideline on this subject. The other perspective will provide information on how a company-wide data integrity programme is launched, which elements are part of it, how to identify gaps in the lab and in production, and how to train employees on the subject. The new ECA Data Integrity Guideline will also be presented in this session.
The fourth of the five sessions the conference is organised in, deals with the topic of statistical / reduced sampling. There you will get familiar with the visions of a European GMP inspector - and with how the guidelines can be implemented from the view of an industry representative.
Finally, the last session has been reserved to invite delegates to intensive discussions and to get involved in the next steps in advancing some of the ECA's working and interest groups, the organisation has established in the recent past. Benefit, for instance, from the GDP Association discussing the challenges (and possible solutions) to GDP. It will be a colorful mix of topics beginning with the segregation in the warehouse, the level of computer validation that is appropriate for wholesalers, up to the necessary training for the Responsible Person (RP) if that person is not a pharmacist.
The revised Annex 15 will be the focus of the Validation Group. Discussions will revolve especially around FAT and SAT documents, including the integration of the documentation of equipment suppliers, ongoing process verification programmes and the integration of the PQR into validation activities.
Recommendation
22/23 January 2025
HPLC Data Integrity - Live Online Training
In the Analytical Quality Control Group, a European GMP inspector will present a view on trend analysis in a QMS. In addition, the group's new out-of-trend / out-ofexpectation guideline will be presented and discussed.
Author:
Sven Pommeranz
... is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy around the topics validation and medical devices.
