ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of October 30, 2002 No. 391

About approval of the Procedure for carrying out certification of production of medicines

On accomplishment of the resolution of the Cabinet of Ministers of Ukraine of September 26, 2002 N 1419 "Some questions of improvement of quality of medicines", considering the directive 2001/83 of the EU of the European Parliament and EU Council, the recommendation of the Convention of pharmaceutical inspections of PH 7/94 and the World Health Organization of WHO TRS N 863, of 1996, I ORDER:

1. Approve the Procedure for carrying out certification of production of medicines it (is applied).

2. To the vice-chairman of State department Krichevskaya O. Ya. provide provision of this order in accordance with the established procedure on state registration in the Ministry of Justice and its publication in mass media.

3. To impose control over the implementation of this order on the Deputy State secretary M. F. Pasichnik.

Approved by the Order of the Ministry of Health of Ukraine of October 30, 2002, No. 391

Procedure for carrying out certification of production of medicines

I. General provisions

1.1. This Procedure No. 1419 "Some measures for quality assurance of medicines" taking into account requirements of directives 2001/83/EC, 2003/94/EC of the European Parliament and Council of the European Union (further - the EU), recommendations of the international system of cooperation of pharmaceutical inspections is developed according to the Law of Ukraine "About medicines", Regulations on the Ministry of Health of Ukraine, No. approved by the Presidential decree of Ukraine of 13.04.2011 467, resolutions of the Cabinet of Ministers of Ukraine of 28.10.2004 (PIC / S) (the document RI 002) and the World Health Organization (WHO TRS No. 863, 1996, TRS No. 908, 2003).

1.2. Certification of production of medicines on compliance to requirements of proper production practice (further - certification) is entered for the purpose of increase and quality assurance of medicines, non-admission to the address in Ukraine of low-quality medicines, creation of conditions for export of domestic medicines by confirmation of conformity of production of the medicines to the requirements of proper production practice (GMP) existing in Ukraine harmonized with requirements of GMP of the EU.

1.3. Certification is performed on voluntary basis.

1.4. Certification is carried out by Public service of Ukraine on medicines (further - Derzhliksluzhba of Ukraine) for residents and nonresidents.

1.5. According to this Procedure certification of production of medicines on the production sites specified in the statement for issue of the certificate of conformity to requirements of proper production practice (in the statement on issue of the conclusion about confirmation of conformity to requirements of proper production practice) according to appendix 1 to this Procedure is carried out (further - the Statement). For carrying out certification of production, performing release of finished pharmaceutical products from the i№bulk form, production of all products in the form of "i№bulk" which is used in the course of release of these medicines shall have the certificates or the conclusions issued according to this Procedure.

1.6. According to this Poryadku Derzhliksluzhba of Ukraine issues the document confirming compliance of production of medicines to the requirements of GMP existing in Ukraine: the certificate of conformity to requirements of proper production practice (further - the Certificate) or the conclusion on confirmation of conformity to requirements of proper production practice (further - the Conclusion).

II. Determination of terms

The terms applied in this Procedure have the following value:

the certified laboratory - laboratory on quality control and safety of medicines which underwent industry certification of Derzhliksluzhboyu of Ukraine according to Procedure for the carrying out industry certification of laboratories for quality control and safety of medicines approved by the order of the Ministry of Health of Ukraine of 14.01.2004 No. 10, registered in the Ministry of Justice of Ukraine 30.01.2004 for No. 130/8729;

production of medicines - the activities connected with serial release of medicines which include everything or at least one of stages of engineering procedure, including purchase of materials and products, packing, packagings and/or markings, storages, the corresponding control, issue of permission to release, and also wholesale trade (distribution) by self-produced products;

the conclusion on confirmation of conformity to requirements of proper production practice - the document issued to Derzhliksluzhboyu of Ukraine, certifying that by results of the carried-out expertize the official document about compliance of production of medicines to requirements of GMP issued by authorized regulatory body of the member country of PIC/S is considered confirming compliance of production of medicines to the requirements of GMP existing in Ukraine;

specialists - specialists of the companies, organizations, the organizations answering to the established criteria are involved (basic education, high professional level, work experience, no conflict of interest, maintaining confidentiality) and Derzhliksluzhboyu of Ukraine for conducting specialized examination, inspection (check), the laboratory analysis of quality of samples of medicines in certification process can be attracted;

the applicant - legal entity or physical person, the owner of the registration certificate (the trade license) and/or licenses for production of medicine which submitted the application for issue of the certificate or Conclusion;

sample (test) from series - the part from series which is selected thus and in such quantity that is representative for all series;

the inspector - the official Derzhliksluzhby of Ukraine with special knowledge, having the higher education on one of the following specialties: the pharmacy, industrial pharmacy, technology of pharmaceutical medicines, chemistry, biology, microbiology, biotechnology, has work experience in production, quality control, management (providing) of quality or creation of medicines and has confirmation of competence concerning GMP or the involved specialist who answers the criteria of rather basic education, high professional level, work experience stated above, the confirmed competence concerning GMP and to requirements for no conflict of interest and maintaining confidentiality is trained on these questions, and/or;

inspection (check) - assessment procedure of compliance of the quality system of the company (production site) and actual state of the available production to the requirements of GMP for the place of implementation of activities existing in Ukraine;

critical violation of requirements of GMP - violation (discrepancy) to requirements of GMP or requirements of the registration file on medicine which brought or can lead to production of low-quality medicine, wholesale, retail trade by low-quality medicines which can cause damage to health or human lives;

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