Certification of qualified persons for pharmaceutical production conditions and requirements of the Eurasian Economic Union

Transcription

1 Certification of qualified persons for pharmaceutical production conditions and requirements of the Eurasian Economic Union Natalya Pyatigorskaya Head of the Department of Industrial Pharmacy of the Sechenov First Moscow State Medical University, Member of the Council for Professional Competence in Pharmacy, Doctor of Science, Professor

2 Regulatory requirements Agreement on common principles and rules for the circulation of pharmaceutical products within the Eurasian Economic Union (Article 9). Decision of the Council of EEC No. 73 dated Attestation procedure of authorized persons for pharmaceutical manufacturers". Decision of the Council of EEC No. 74 of "Approved Procedure for Establishment and Maintenance of the QP Register of the EAEU pharmaceutical manufacturers". Decision of the EEC Council No. 77 on "Approved Rules of EAEU Good Manufacturing Practices" (Appendix No. 16). Decision of the EEC Council No. 78 of Registration and Evaluation Rules for Pharmaceutical Products for Medical Use"

3 Agreement on unified principles and rules of pharmaceutical circulation in the Eurasian Economic Union Article 9 Pharmaceutical manufacturing 2. A qualified person at the pharmaceutical production site must receive certification from the member state s regulatory authority in accordance with the attestation procedure approved by the Commission. Certified QPs are listed in the EAEU Register of qualified persons of pharmaceutical manufacturers. The Commission establishes and maintains the Register in accordance with the procedure approved by the Commission. 3. In case of improper performance of their duties, qualified persons of pharmaceutical manufacturers shall be held liable in accordance with the legislation of the member states.

4 EEC Council Decision No. 73 Attestation procedure for qualified persons of pharmaceutical manufacturers" A qualified person must have at least three years of experience in production or QA/QC, and be a graduate in one of the following areas: chemistry, chemical engineering, pharmaceutical chemistry, biology, biotechnology, microbiology, pharmacy, general medicine, or veterinary. Employees who have degrees in physics and engineering (cryogenic engineering and low-temperature physics) are also eligible for certification as qualified persons for production of medical gases. In radiopharmaceuticals production, staff with degrees in nuclear physics and radiophysics (nuclear power and technology, radiophysics) are also eligible for certification.

5 Qualification Requirements (subjects, trainings) effective as of January 1, 2019 The qualified person (with the exception of those for medical gases and radiopharmaceuticals) must major in the following disciplines (subjects, trainings) of higher education or advanced courses: 1. applied (medical and biological) physics; 2. general and inorganic chemistry; 3. organic chemistry; 4. analytical chemistry; 5. pharmaceutical chemistry (including drug analysis); 6. biological chemistry; 7. physiology; 8. microbiology; 9. pharmacology; 10. pharmaceutical technology; 11. toxicology; 12. pharmacognosy.

6 The certification procedure includes vetting the education, professional orientation, and work experience against the EAEU requirements and GMP rules of the Union for qualified persons. Per results of the vetting, the regulating authority of the EAEU member state certifies the qualified person indicating types of pharmaceutical production for which the QP has been found eligible.

7 Verification of higher education conformity Order No of the Russian Ministry of Education and Science dated Approved lists of major disciplines and academic areas in higher education Order No. 201 of the Russian Ministry of Education and Science dated February 17, 2011 Verification of higher education conformity..."

8 Order N 429-n of the Russian Ministry of Labor dated May 22, 2017 Approved professional qualifications for QA Experts in Industrial Pharmacy" Radio physics and electronics Biotechnology Chemistry Biology Biochemistry Microbiology Radio physics and electronics Medical and preventative care Cryogenic engineering and low-temperature physics Refrigeration, cryogenic engineer, and air-conditioning Chemistry, physics, and mechanics of materials Inorganic chemical engineering Chemical defense engineering Organic chemical engineering Chemical engineering of synthetic biologically active substance Chemical engineering of high-molecular compositions Pharmacy Medical biochemistry Veterinary Nuclear physics and technology Biochemical production Radiation safety Engineering of high-molecular and high-potent compositions and devices Chemical engineering rare elements and materials based on them Machines and devices of chemical production Basic processes of chemical production and chemical cybernetics Fundamental radiophysics and physical electronics Radiation safety of humans and environment

9 Verification of higher education conformity Inconsistent Biology and Chemistry Teacher major: Biology, Chemistry EDUCATION AND PEDAGOGICAL SCIENCES Technology of production and organization of public catering INDUSTRIAL ECOLOGY AND BIOTECHNOLOGY Ecology and natural resources management EARTH SCIENCES Consistent Biology. Teacher of Biology BIOLOGICAL SCIENCES Biotechnology. Industrial ecology and biotechnology. INDUSTRIAL ECOLOGY AND BIOTECHNOLOGY Food Biotechnology BIOTECHNOLOGY Engineer physicist - higher education PhD in Chemistry

10 Education in "Industrial Pharmacy"

11 Unified register of certified QPs (EEC Council Decision No. 74) Open sources data Certificate of the qualified person: certificate number; title of the document; date of issue; name of the regulatory authority issuing the certificate. First date as QP. Production activity covered by the QP certificate. Expiration/cancellation date of QP certificate

12 date of birth; citizenship; address; Classified information contained in the Unified Register education: name of the university/college, start date, graduation date, qualification (degree), diploma number; information on advanced education: name of the university/college, start date, graduation date, area of study, qualification (degree), diploma/certificate ID number; Information on previous employment: banking details address; contact information of the enterprise (organization): type of communication, area and zip codes . job title; date of employment; date of resignation. information about current employment: job title; date of admission to the position; Work experience in pharmaceutical production, quality assurance or quality control.

13 QP change of employment If a Qualified Person departs to a new place of work, the regulatory authority of the member state that issued the QP certificate makes relevant corrections in the national part of the Unified Register, even if the new employment is located on the territory of another member state.

14 Questions pending clarification at the EAEU level A unified list of production activities requiring QP certification. What will be understood under First date as Qualified Person? The date of the QP certificate issuance? It might be a challenge to monitor individual appointments of Qualified Persons. Procedure for information updates: what information, other than the current employment, should be updated (and how soon?). Possible certification of individuals to act as QPs in the declared activities. Mutual recognition of QP certificates, in the event of different certification procedures in the member states

15 THANK YOU FOR YOUR TIME! Contact information: т. 8 (499)