ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of January 14, 2004 No. 5

About approval of the Procedure for obtaining, accounting, storage and content of test strains of microorganisms for monitoring procedure of quality of medicines on microbiological indicators

In pursuance of requirements of the Laws of Ukraine "About medicines", "About providing sanitary and epidemic the population benefit" and the State Pharmacopoeia of Ukraine, for the purpose of establishment of single procedure for obtaining, accounting, storage and content of test strains of microorganisms I ORDER:

1. Approve the Procedure for obtaining, accounting, storage and content of test strains of microorganisms for monitoring procedure of quality of medicines on microbiological indicators (further the Procedure) which is applied.

2. Determine that the Procedure becomes effective in three months from day of its state registration.

3. To provide to the chief state health officers of the Autonomous Republic of Crimea, areas, cities of Kiev and Sevastopol, cities, areas control of observance of sanitary and anti-epidemic measures by business entities in case of performance of works on quality control of medicines on microbiological indicators.

4. The state inspectorate for quality control of MZ medicines of Ukraine, to the state inspectorates for quality control of medicines in the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol to provide control of execution of requirements of this Procedure by research establishments and the organizations which have in the subordination collections of microorganisms, and business entities which use test strains of microorganisms for monitoring procedure of quality of medicines on microbiological indicators.

5. To impose control of execution of this order on the deputy minister of health care of Ukraine - the chairman of Public service of medicines and products of medical appointment of the Bee-keeper M. F.

No. 5 is approved by the Order of the Ministry of Health of Ukraine of January 14, 2004

Procedure for obtaining, accounting, storage and content of test strains of microorganisms for monitoring procedure of quality of medicines on microbiological indicators

1. General provisions

1.1. This Procedure establishes the procedure of obtaining, accounting, storage and content of test strains of microorganisms which are intended for monitoring procedure of quality of medicines on microbiological indicators.

1.2. Sources for receipt of test strains of microorganisms which are intended for monitoring procedure of quality of medicines is the Ukrainian collection of microorganisms of Institute of microbiology and virology of D. K. Zabolotny of NAS of Ukraine (Kiev), the Museum of microorganisms of Institute of epidemiology and infectious diseases of name L.V, pathogenic for the person. Gromashevsky AMN of Ukraine (Kiev), their branches (further - collections).

If necessary the Ministry of Health of Ukraine in addition determines other collections.

1.3. Action of the Procedure extends to all collections and business entities irrespective of pattern of ownership and subordination (further - subjects of managing) which contain test strains of microorganisms and/or carry out quality control of medicines with use of test strains of microorganisms of the III-IV groups of pathogenicity.

1.4. In the course of monitoring procedure of quality of medicines on microbiological indicators subjects of managing shall use the test strains of microorganisms determined by the State Pharmacopoeia of Ukraine (further - GFU) and specified in the List of test strains of the microorganisms intended for monitoring procedure of quality of medicines on microbiological indicators (appendix 1).

1.5. Control of observance by subjects of managing of requirements of the sanitary legislation, sanitary and anti-epidemic measures in case of work for quality control of medicines on microbiological indicators is performed by institutions of the Public sanitary and epidemiologic service.

1.6. Control over the implementation by subjects of managing of requirements of this Procedure is exercised by the State inspectorate for quality control of MZ medicines of Ukraine (further - the State inspection of MZ) and the state inspectorates for quality control of medicines in the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol (further - territorial inspections).

2. Terms and determinations

In this regulatory legal act the terms below are used in such value:

Reference test strain - net culture of microorganism of this type which has characteristic physiological, morphological and biochemical properties.

Subculture - the culture of microorganism received by passage through the corresponding full-fledged nutrient mediums.

Culture of long-term storage - culture of reference test strain in the conditions of long-term storage (lyophilicly dried up culture, cryopreservation; the semi-fluid circle under sterile mineral (vaseline) oil, the slanted agarizovanny circle).

Culture of temporary storage - culture of reference test strain in the conditions of temporary storage on the corresponding circle.

Culture of target use - the subculture which passed no more than 5 passages after seeding from culture of temporary storage held for use in the analysis.

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