Seminar 7 - Diary by William Chin
28 July 2014, Strasbourg - This year the European Directorate for the Quality of Medicines & Healthcare (EDQM) is celebrating its 50th anniversary on the adoption of the Convention of European Pharmacopoeia and the establishment of its secretariat. Indeed it has been a privilege to step foot in the institution who has played an important role in protecting public health through supporting the implementation and monitoring the application of quality standards for safe medicines. Seminar 7 was held at the EDQM in Strasbourg with the theme “The Roles Of The Supervising Authorities And The Essential Characteristics Of Quality Systems”. Dr. Ralf Hess (PAREXEL) was the course leader for this 3 days seminar.
We were fortunate to have Dr. Susanne Keitel, Director of EDQM, to open the session with her insightful presentation on the role and structure of the EDQM, its activities and how the institute is responsible and committed for the post marketing surveillance of medicinal products authorized in the EU. Dr. Keitel explained that the EDQM is also celebrating the 20th anniversary of the European Official Medicines Control Laboratories (OMCL) Network and of the procedure for Certification of Suitability to the European Pharmacopoeia Monographs, and since then has pioneered a lot of initiative to ensure the quality of medicinal products in the EU.
Dr. Hess presented a series of lectures on the characteristics of quality management systems and its intricacy within the EU. The different types of quality management systems applied in the EU and how they are regulated and executed were explained in detail. In addition, the principles of GMP and GLP as well as the legal requirements for obtaining a manufacturing authorization or an authorization for importation were explained. It is the obligations of the sponsor to ensure that GMP manufacturing authorization or an authorization for importation from third countries is obtained accordingly. The sponsor is also responsible to designate a Qualified Person to ensure consistency and quality in batch release of medicinal products. The principle aim of GDP is to ensure maintenance of the level of quality throughout the distribution chain of medicinal products. In case of product failure, The Rapid Alert System Product is designed to recall defect product from the EU market.
Dr. Gabriele Dallmann (EUCRAF) gave a presentation on the special GMP considerations for biopharmaceuticals. Unlike the NCEs, the starting materials of biopharmaceuticals are highly variable as they originate from different sources such as cells, blood products, bioreactors, transgenic plant and animals. Therefore to ensure the consistency of the quality in these products, designated procedures such as IPC and sterility measure are built into each step of the manufacturing process. Using the example of Module 1, Dr. Dallmann showed how Regulatory Affairs personnel have important roles as the interphase between the Quality Control and Quality Assurance Departments in order to ensure GMP authorization of manufacture and testing facilities, GLP compliance of preclinical testing and GCP compliance of clinical trials are fulfilled.
Dr. Bernd Raffelsberger (formerly Pfizer) gave interesting anecdotes on his experience with inspections conducted by the different inspectorates from Europe and other national competent authorities. Dr. Karl-Heinz Buchheit (EDQM) and Dr. Catherine Milne (EDQM) spoke about the OMCL Network, CAP testing program and Market Surveillance and Official Control Authority Batch Release (OCABR). Dr. Dagmar Chase (Clinrex) spoke on the principles of GCP, which is primarily aim to protect the interest of trial subjects and integrity of trial results. Various quality document subjected to GCP include clinical trial protocol, informed consent, case report forms were explained comprehensively.
In conclusion, Seminar 7 has enabled me to understand the characteristics of the pharmaceutical quality system in EU and the particulars of the various types of GxP. These multifaceted activities and coordinated responsibilities are necessary to ensure that only medicines of high standard that are safe and effective will reach the patients.
William Chin is currently undertaking Master’s in Regulatory Affairs for Biopharmaceuticals at EUCRAF and previously obtained a Ph.D. in Biomedical Science from the Department of Pharmacy, National University of Singapore.