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GMP inspection: mastery of inspectors and manufacturers

On September 24, as part of the IV All-Russian GMP conference, the first part of the GMP Inspection workshop was held. It should be noted that the agenda of this event is formed by industry representatives themselves, participating in online voting and surveys.

The program was moderated by Elena Denisova, Deputy Director of the Pharmaceutical and Medical Industry Development Department of the Ministry of Industry and Trade of the Russian Federation, and Natalia Chadova, Head of the Inspection for Drug Production and Expertise at GILS and NP. The main areas of discussion were re-inspection, regulatory requirements and classification of non-conformities.

At the beginning of the event, Yulia Grishina, Deputy Head of the Department for Inspecting the Production of Medicines, Federal State Institution “GILS and NP” of the Ministry of Industry and Trade of Russia spoke, who presented the main provisions in the field of inspection. Then, foreign colleagues shared similar experiences.

Elizabeth Montezoro, inspector of the Italian Medicines Agency (AIFA), spoke about the stages of production and drug testing that are in compliance with European and Italian legislation. She noted that re-inspection in Italy is based on a risk-based approach. The importance of risk assessment was also highlighted by Jesus Herrera, coordinator of psychotropic drugs of the Venezuelan Autonomous Health Monitoring Service. In her opinion, after the GMP inspection it is important to obtain information about the true causes of deviations in order to adjust the process.

Olga Maklakova, Quality Director at Akrikhin, shared her experience of re-inspecting the company's production sites and outlined the range of problems that manufacturers face in doing so. In particular, questions arise regarding corrective and preventive actions (CAPA). Speaking about what she would like to propose to improve the quality control system, the speaker suggested taking into account the integrity of the manufacturer and the positive history of its products on the Russian market. Recall that Olga Maklakova became the winner of the "Director for Quality" competition, the award ceremony of which was also held as part of the conference in Svetlogorsk.

Another important issue from the point of view of inspection considered by participants was the validation of processes. Nikita Novikov, a leading specialist in the department for inspecting the production of medicines, Federal State Institution “GILS and NP” of the Ministry of Industry and Trade of Russia, informed about the current regulatory requirements, their implementation and assessment during inspections,. In particular, he dwelled on the relevant updates of EEC Decision No. 77, in part of Appendix 15, which is harmonized with the current requirements of the EMA. The speaker also drew the attention of specialists to the fact that if the drug is new, then its validation will be checked without fail.

Heinz Schmidt, Director of Life Science for Russia and the CIS at Merck, outlined the current trends in pharmaceutical production that are common to different countries of the world ̶ these are personalization of drugs, changes in the requirements for processes, changes in production cycles, and minimization of capital costs. Together, all of these reasons affect the fact that inspectors must have a deep understanding of the increasingly complex technical processes. The expert paid particular attention to the issue of relations between the producer and supplier of raw materials, as an important part of the formation of product quality.

“It is important to establish cooperation between the manufacturer and the supplier, because each time it is a“ new bundle ”. According to our experience, unfortunately, such discussions can take 6–9 months. And this time is spent only on the construction of a work scheme. Next, you need to develop and test a prototype of the drug, generate experience before the actual process is implemented. At the same time, you need to think about how to build a dialogue with regulatory authorities, ”said Heinz Schmidt.

On the classification of typical discrepancies identified during the inspection process (FBU GILS and NP), Vitaly Kazyulkin, chief specialist of the department for inspecting the production of medicines, FBU GILS and NP of the Ministry of Industry and Trade, spoke further. The colleague was supported by Natalia Chadova, head of the Directorate for Inspecting the Production of Medicines and Expertise of GILS and NP.

“Inconsistencies are perhaps a tough topic for companies and inspectors. During the final meetings that take place after the inspection, a serious confrontation often begins. Company representatives strive to uphold the appropriate level of their technology and products. In the future, manufacturers send additional materials to our department, many meetings are held. Classification of discrepancies by groups, types of products and production is a very complex process. Assigning one or another category of non-conformity is an art that requires skill from the inspector, ”concluded Natalia Chadova.

Chantal Kazolt, Executive Director for Quality of Amgen (USA) and Isabella Magic, Global Director for Quality, Dechra (Croatia) also discussed the classification of non-conformities.

On September 25, the second part of the GMP Inspection workshop will be held. During the event, experts will give answers to questions asked by participants on the conference website, as well as directly in the hall.

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