Registered by the
Ministry of Justice of Ukraine
January 30, 2004
of January 14, 2004 No. 10
About approval of the Procedure for carrying out industry certification of laboratories for quality control and safety of medicines
According to the Regulations on Public service of medicines and products of medical appointment approved by the resolution of the Cabinet of Ministers of Ukraine of June 2, 2003 No. 789,
2. Abolish orders of Goskommedbioprom of 22.12.1997 No. 133 "About creation of System of certification and accreditation of test (analytical) laboratories and laboratories on quality control of medicines and auxiliary materials", of 21.04.1998 No. 52 "About certification of test laboratories of technological control and quality control of pharmaceutical products (experienced laboratories and Quality Departments laboratories)", of 05.06.1999 No. 78 "About approval of the schedule of certification of test laboratories (experienced laboratories and laboratories of inspection departments of quality) of the companies making remedies".
3. To the head of department - inspectorate on proper work, distributor practice, control of observance of licensed conditions of Public service of medicines and products of medical appointment to Podpruzhnikov Yu. V. 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.
4. To impose control of execution of this order on the deputy minister - the Chairman of Public service of medicines and products of medical appointment M. F. Pasichnik.
V. V. Zagorodny
The Order of the Ministry of Health of Ukraine is approved on January 14, 2004 No. 10
1.1. This Procedure is developed according to the Regulations on Public service of Ukraine on medicines and control of drugs approved by the resolution of the Cabinet of Ministers of Ukraine of August 12, 2015 No. 647 taking into account provisions manual of ST-N of MZU 42-4.0: 2016 "Medicines. Proper production practice", approved by the order of the Ministry of Health of July 29, 2016 No. 798 (further - the Management), GSTU SO/EC 17025-2001 "General requirements to competence of test and calibrating laboratories", recommendations of the Convention of pharmaceutical inspections (PIC/S) of PH 2/95 "Recommendation about the quality system for official laboratories about control of drugs", recommendations of the World Health Organization (WHO) "Proper practice for national laboratories on control of medicines" (WHO TRS N902, 2002).
1.2. The procedure extends to laboratories on quality control and safety of medicines (physical and chemical, microbiological, biological and so forth) who are legal entity or structural division of the subject of housekeeping and also safety of medicines irrespective of their patterns of ownership and subordination exercise quality control (further laboratory).
1.3. Industry certification of laboratories is performed by Public service on medicines and control of drugs (further - Gosleksluzhba of Ukraine) according to this Procedure. Specialists of the companies, organizations and organizations can be involved in examination when carrying out certification.
1.4. Industry certification of laboratories is performed on a voluntary basis.
In this Procedure terms are used in such value:
Certification of laboratory - recognition of competence of laboratory by the criteria of certification established by this Procedure.
The applicant - laboratory or the subject of housekeeping which part it is, submitted the application for carrying out industry certification according to this Procedure.
Independence of laboratory - independence of the producer, the consumer, developer.
The certificate about certifications (certificate) - the document which is issued by Gosleksluzhboy of Ukraine by results of certification and certifies competence of laboratory.
3.1. Criteria of certification of laboratory are:
3.1.1. For the laboratories functioning as a part of subjects of housekeeping - compliance to the Installation provision concerning the organization of quality control and safety in case of production of medicines and to recommendations of GSTU ISO/IEC 17025-2001 "General requirements to competence of test and calibrating laboratories" (except for requirements to competence of calibrating laboratories) which are approved with Installation provisions;
3.1.2. For other laboratories - compliance to recommendations of GSTU ISO/IEC 17025-2001 "General requirements to competence of test and calibrating laboratories" (except for requirements to competence of calibrating laboratories) which are approved with recommendations of PIC/S PH 2/95 "Recommendation about the quality system for official laboratories about control of drugs" and to WHO recommendations "Proper practice for national laboratories on control of medicines" (WHO TRS N 902, of 2002) concerning the organization of independent laboratory control of medicines.
It is excluded
5.1. The procedure of industry certification includes such stages:
filing of application on industry certification;
decision making concerning issue of the certificate;
registration and issue of the certificate.
5.2. For receipt of the certificate the applicant submits to Gosleksluzhbu of Ukraine the application of the established sample with indication of area of industry certification (appendix 1). The application is directed personally or through person authorized, in accordance with the established procedure, in paper and/or electronic type. Such documents are enclosed to the application (or their copies certified in accordance with the established procedure): constituent documents for laboratory which is legal person, regulations on laboratory and/or inspection department of quality (engineering supervision) which part it is, approved as the head of laboratory or the head of the subject of housekeeping, installation on quality of laboratory (appendix 2), the passport of laboratory (appendix 3).
5.3. The Gosleksluzhba of Ukraine till 15 working days after registration date of the statement carries out preliminary expert examination of set of documents which are enclosed to the application.
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