LOGFILE No. 46/2017 – International GMP – Six Questions for Jacques Morénas
International GMP – Six Questions for Jacques Morénas
5 minutes reading time
Jacques Morénas, Deputy-Director at ANSM (France), is a European GMP grandee. He has worked for nearly 35 years in the performance and management of GMP inspections at the French supervisory authority. International GMP is one of his passions. For a long time, he has been actively involved in PIC/S and is one of its former chairmen. We are pleased that he has agreed to answer some questions for our LOGFILE readers. Here are the questions and the intriguing answers.
One of the top concerns that the pharmaceutical industry expresses is regulatory uncertainty. Harmonisation of GMP requirements is a constant item on the wish list of internationally acting companies. Where do we stand today?
Many structures in the world are working in the field of GMP harmonisation as, for example, WHO, the European Commission, the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the ASEAN .… Hopefully, GMP guides are equals among these structures. The GMP guides by themselves are surely not the only useful tools for harmonisation throughout the world. Interpretation guidances, training of inspectors, sharing of practices and information are also key points. It is also very important to work on compliance management …. What are the decisions taken by the regulatory agencies after GMP inspections? Are they defined, consistent, transparent, harmonised?
Future trends in pharmaceutical manufacturing are, for instance, Pharma 4.0, continuous manufacturing, single-use technologies and personalised medicine. How will these trends influence GMP inspections? Will inspections of the future differ from today's?
From my perspective, these trends will not influence GMP inspections. The assessment of a manufacturing site regarding applicable GMP rules will continue to be the responsibility of the inspectors. Guidances will evolve, as well as training inspectors to take them on board, but not the principles of the inspection. Therefore, in the future (as today), it will be increasingly important to consider the entire lifecycle of the product, which is broken up among different entities located in different countries. How to ensure an acceptable level of GMP compliance along this lifecycle is very challenging to both industry and regulatory agencies. This is the most important point and I am not sure that the new document ICH Q12 will help in this matter.
1 November 2017 marked the beginning of the transition period of the GMP Annex of the Mutual Recognition Agreement (MRA) between EU and US. By now, eight EU Member States have been fully assessed by the US FDA, and the MRA is in force on a provisional basis. What are your expectations for the MRA? Will all commitments laid out in the new transition period be met?
First, I would like to emphasize that this assessment is one very efficient way to improve and ensure consistency among the EU Member States in the field of GMP. Audits (peer review) done within the framework of the EU Joint Audit Program are very encouraging, and this constitutes a first success in this field. For me, this agreement is a win/win process for both industry and regulatory agencies for better allocation of resources and avoiding duplication of work. We will be able to concentrate our efforts where they are necessary. And I am really looking forward to this gain. For now, we are still at the beginning of the process and, as ANSM, I am happy with the very positive contacts we are developing now with our US FDA colleagues.
Our international survey on GMP inspections and audits, the GMP Compliance Index 2017, revealed that audits are rated more arbitrarily than inspections. In contrast to inspectors, auditors tend to raise very specific aspects that are not stipulated by GMP regulations. What is your experience in this respect?
From a regulatory point of view and with my experience, I would like to make a few points concerning the field of the audits. How are auditors qualified? What resources are devoted to the audit (number of auditors, time …)? What is the status regarding conflict of interests? What is the real scope of the audit? Does the audit report really cover the scope of the audit? These questions must be taken into account when considering performing an audit.
This interview was conducted by our Editor Dr. Sabine Paris:
with Jacques Morénas
Deputy-Director at ANSM, France