Sanofi Russia supported the master class on GMP-inspection that marked the beginning of the busy schedule day. Natalia Chadova – Head of the Administration for Pharmaceutical Products Inspection and Evaluation of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade moderated the event.
The participants discussed inspection of drug manufacture, management of GMP inspections, as well as differences between GMP inspectorates in different countries. Elena Denisova, Deputy Head of Department of Pharmaceutical and Medical Industry Development of the Russian Ministry of Industry and Trade noted: «Our inspectorate needs assistance in its first steps, the Russian pharmacopoeia – however – does not need to be adjusted to others. The first Russian pharmacopoeia appeared at the age of Catherine the Great, that is, in the mid-18th century, so the history of our pharmacopoeia is very rich; we have experience no less than other countries. We say to harmonization, but no to mimicking.»
Olga Maklakova, Quality Director Akrihin Staraya Kupavna raised the issue of GMP inspections from the manufacturer’s point of view. In her speech, she touched upon the GMP inspection of Russian manufacturers by the EAEU procedures, «I think it is in the applicants’ best interests to submit registration dossiers according to the EAEU rules, and we are all pressed for time prior to the inspection. Therefore, QA should be proactive in registration, supportive of the company’s intent to receive EAEU certificates, and take concerted and timely actions.»
At the end of the master class, the results of the survey conducted by the organizers prior to the conference were summed up to identify areas of the industry and GMP inspections, which should be improved according to manufacturers and experts.
Manufacturing regulation of certain pharmaceuticals groups (radiopharmaceuticals, blood products, etc.) were at the center of discussion among pharmaceutical industry professionals at a master class supported by Pharmimex.
Experts, including foreign inspectors, raised the following questions: licensing of nuclear medicine facilities, production of API’s for RPh’s, and requirements for new RPh’s development.
Natalia Aladysheva, Deputy Head of the Division for Pharmaceutical Licensing and Inspections of the Russian Ministry of Industry and Trade moderated the class. She established a successful dialogue between representatives of the state inspectorates and drug manufacturers.
Igor Falkovsky, Head of the Department of Good Engineering Practices of the State Institute of Drugs and Good Practices moderated the third day’s master class on data integrity. It brought together representatives of international companies responsible for compliance. At the master class, Gilda D’Incerti, PQE General Director presented a Data Integrity Guide for the industry, which was developed in cooperation with the The State Institute of Drugs and Good Practices.
It is a rarity for a conference that participants would take every seat on the last day; intensity of the master classes at the All-Russia GMP conference hit the records for the third year in a row. It calls for keeping up the standards and prepare for the next one in 2019.
Partners of the III All-Russia GMP Conference:
General partner – Valenta Pharm; strategic partners: Gedeon Richter, TatKhimPharmPreparaty JSC; partners of the conference: Astellas Pharma, Takeda Pharmaceuticals, TEVA; partners of the sessions: Akrihin, Amgen, Bosnalijek, PRO.MED.CS Prague a.s., Pharmimeks, Sanofi Russia; special partners: GEROPHARM, NatsImBio.
The conference has been organized by the Russian Ministry of Industry and Trade together with the State Institute of Drugs and Good Practices, the conference is operated by «S-Group» Center for Corporate Communications.