New GMP trends in the EAEU regulatory system
On Day Two of the III All-Russia GMP conference, Elena Denisova, Deputy Head of the Department of Pharmaceutical and Medical Industry Development of the Russian Ministry of Industry and Trade, moderated a panel discussion dedicated to New GMP trends in the EAEU regulatory system .
During the international day of the conference, the panelists reviewed a number of issues including new trends in the technical regulation of the EAEU good manufacturing practices, common pharmaceutical market, rules and procedures of GMP inspections in accordance with the EAEU guidelines, current inspection standards.
Valery Koreshkov, Member of the EEC Board (Minister) for Technical Regulation, spoke about legal foundations of GMP regulation in the Eurasian Economic Union. The commission is currently developing a large block of the 3rd level documents covering all key aspects of GMP inspections.
‘A GMP compliance certificate is an essential part of the registration dossier. The GMP rules have been developed based on international experience, and European guidelines, in particular.’
Dmitriy Rozhdestvenskiy, Head of the Coordination Department for drugs and medical devices circulation of the EEC Department of Technical Regulation and Accreditation, drew the audience’s attention to different types of inspections that must considered and correctly interpreted to shape up proper marketing tactics, ‘The first thing that comes to mind, in addition to the existing routine and random inspections, they can be divided by team composition into single-auditor and team inspections.’
Professor Natalya Pyatigorskaya, Head of the Industrial Pharmacy Department of the Sechenov First Moscow State Medical University, Member of the Council for Pharmaceutical Competence, Ph.D., expanded on EAEU regulatory requirements for certification of qualified persons in pharmaceutical manufacture. According to Professor Pyatigorskaya, the certification procedure includes verification of required education, relevant training and work experience of qualified persons in line with the EAEU procedure and GMP rules of the Union, regulating QP job portfolio. Based on the findings, a respective EAEU regulating authority certifies the QP indicating pharmaceutical manufacturing activities for which the QP was certified.
GDP inspections results for the past years came from Yelena Stepkina, Head of the Administration for Implementation and Development of Good Pharmaceutical Practices and International Standards of the National Center for Expertise of drugs, medical devices and medical equipment of the Kazakhstan Ministry of Health and Social Development. The denial rate of GDP inspection results is going down against last year figures. Yelena mentioned some defects leading to deviations: improper storage, lack of evidence of equipment qualification, inadequate documentation, and others.
Nurylbek Asylbekov, Deputy Chair of the Pharmaceutical Committee of the Kazakhstan Health Ministry shared GMP-inspections experience. Among major defects, he noted lack of validation of critical processes, lack of qualification of technological equipment, lack of data provided in the registration dossier and contamination in cleanrooms.
Chinara Mambetalieva, Head of the Quality Assessment of Drugs and Medical Products, Department of Medicines and Medical Devices, Kyrgyzstan Health Ministry, told the audience about legal framework governing the establishment of Pharmaceutical Inspectorate in the Kyrgyz Republic. As provided for in the General Quality Requirements of EAEU Pharmaceutical Inspectorates (Decision No. 82 of the EEC Council dated November 03, 2016) the Statute of the Department of Good Practices and Quality System of the Pharmaceutical Inspectorate are currently in the works. It will include policies, quality manual, SOPs, records and reports, training for the pharmaceutical inspectors. Among upcoming trends, Chinara mentioned effective interaction with inspectors of the EAEU regulatory authorities in the area of pharmaceutical circulation and eventual integration into the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
That has not exhausted the discussion. Participants and speakers will review the regulatory system in detail during master classes scheduled for tomorrow that will be the Day of Best Practices. Practical master classes of leading industry experts on current issues of pharmaceutical manufacture: GMP inspection, data integrity, qualified persons, production regulation (radiopharmaceuticals case study).
“Last year, we noted genuine interest that QC/QA experts demonstrated in our practical sessions. Most of the participant preferred to attend the GMP inspection section: delegates with great interest and involvement took part in our event, where we navigated the audience through the most difficult situations that our inspectors encountered. This year we plan to increase the site to accommodate all comers; also we will have no parallel sessions so our guests are able to visit all every master class, “- says Natalia Chadova, Head of the Administration for Pharmaceutical Products Inspection and Evaluation of the State Institute of Drugs and Good Practices.
The discussion was held with the support of PRO.MED.CS Prague as.
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.
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