5TH EUROPEAN GMP CONFERENCE DEDICATED TO 50 YEARS OF GMP
Delegates from more than 20 countries worldwide will meet from 6-7 June 2013 at the 5th European GMP Conference in Heidelberg. The ECA is dedicating the fifth biennial European GMP Conference to recognise the 50th anniversary of the first published GMP regulations and further the work towards a harmonised set of GMP regulations for medicinal products.
The first GMP rule was published in 1963 by the US FDA to protect the health of drugs' consumers. Since then, the development of the GMPs has been tremendous. GMP is the accepted worldwide "gold standard" for the manufacturing and control of medicinal products. A key note presentation by ECA Advisory Board Member Dr. Jean-Denis Mallet will highlight the past developments, the current status and will provide an outlook to the future of GMP. He will also discuss a possible new approach to GMP which is currently also discussed by Dr Janet Woodcock from the US FDA. In a recent article she proposed to introduce "quality metrics". These metrics are already used in other branches. Stakeholders would receive more information than just "GMP compliant" or "out of GMP compliance". A triple A like the rating in finance environment or a 100 point scorecard system might serve as model. By this, stakeholders would be in the position to compare the quality level and reward companies who invest in quality.
In addition three sessions will deal with major GMP developments. During these sessions members of the different ECA working groups will also inform about the latest ECA Guides. GMP Conference delegates will receive a free copy of the Good Practice Guide on Validation and Version 2 of ECA 's SOP on OOS.
Session 1: Good Practice Guide on Validation
The European concept to modern process validation is not clear yet. The ECA has therefore set up an Expert working group to develop a Good Practice Guide. This document is intended to provide support to both regulators and industry. On one hand the Guide is supposed to comprise the main elements of a new approach ("what to do"). On the other hand it can also serve as a supporting guide for their implementation ("how to do"). The document contains information and examples on
- Risk-based Approach to Process Validation
- Risk-based Qualification
- Statistics in Process Validation and Continuous Process Verification
- Process Validation and Statistical Trending in Biopharmaceutical Manufacturing and a
- Special Case: Legacy Processes.
Recommendation
22/23 January 2025
HPLC Data Integrity - Live Online Training
Session 2: Good Distribution Practices - Interpretation needed
The long awaited EU GDP Guideline was issued by the EU Commission on 7 March 2013. This document will replace the current GDP Guideline published in 1994 (94/C 63/03). By this, GDP will be closely linked to the GMP environment. The new GDP Guideline now also applies to brokers in addition to wholesalers and manufacturers of pharmaceuticals. The responsibility for products during storage and distribution will remain with the manufacturers up to the point of sale, where wholesale dealers will take ownership. It is clear that all parties involved in the pharmaceutical supply chain must comply with these requirements. Therefore service providers such as transportation companies need to gain good understanding of what is required to be able to provide appropriate service to their clients. The questions that need to be discussed in this regard are: How does the shipment need to be tracked? How can the quality be guaranteed? What level of supervision is necessary and what can be outsourced? To find answers to these and other questions the ECA Working Group is currently developing a Good Practice Guide in cooperation with the PQG Group.
Recommendation
5/6 February 2025
Handling of Foreign Particles in APIs and Excipients - Live Online Training
Session 3: Version 2 of ECA's SOP on OOS
ECA's Analytical Quality Control Working Group defined the generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE, and OOT results as its first project. In a first step in this project a SOP flow chart had to be developed and reviewed by an OOS Review Team consisting of more than 100 ECA members. The second step comprised the development of a Draft OOS SOP. For this draft the Working Group also received about 25 responses from the Review Team members, containing a lot of detailed suggestions and comments for the final OOS SOP. Version 1 of the OOS SOP was launched at an ECA Conference in Prague in June 2012. Based on the feedback received an updated Version 2 was developed which will be presented at the 5th European GMP Conference in Heidelberg.
Delegates are invited to discuss the upcoming developments with the Chairs and Co-Chairs of the Working Groups in meetings that will be organised on the afternoon of the second day of the conference.
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
