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ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of September 25, 2012 No. 646

About approval of the Technical regulation "About Safe Storage of Medicines in the Pharmaceutical Organizations and the Organizations of Health Care and the Sanitary Mode of the Pharmaceutical Organizations"

(as amended of the Order of the Government of the Kyrgyz Republic of 20.01.2015 No. 15)

According to the Law of the Kyrgyz Republic "About bases of technical regulation in the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

1. Approve the Technical regulation "About Safe Storage of Medicines in the Pharmaceutical Organizations and the Organizations of Health Care and the Sanitary Mode of the Pharmaceutical Organizations" according to appendix.

2. To the Ministry of Health of the Kyrgyz Republic in accordance with the established procedure to make offers on reduction of regulatory legal acts of the Government of the Kyrgyz Republic in compliance with the Technical regulation specified in Item 1 of this resolution.

3. To impose control of execution of this resolution on department of social and humanitarian development of Government office of the Kyrgyz Republic.

4. This resolution becomes effective after six months from the date of official publication. This resolution is effective before entry into force in the territory of the Kyrgyz Republic of the corresponding technical regulation of the Customs union.

 

Prime Minister

Zh. Satybaldiyev

Approved by the Order of the Government of the Kyrgyz Republic of September 25, 2012, No. 646

Appendix

Technical regulation "About Safe Storage of Medicines in the Pharmaceutical Organizations and the Organizations of Health Care and the Sanitary Mode of the Pharmaceutical Organizations"

Chapter 1. General provisions

1. The technical regulation "About Safe Storage of Medicines in the Pharmaceutical Organizations and the Organizations of Health Care and the Sanitary Mode of the Pharmaceutical Organizations" (further - the Technical regulation) No. 137 is developed according to the laws of the Kyrgyz Republic "About medicines", "About regulatory legal acts of the Kyrgyz Republic", the order of the Government of the Kyrgyz Republic "About adoption of the Technical regulation "About Safety of Medicines for Medical Application" of April 6, 2011.

2. The technical regulation is applied for the purpose of safety of medicines and protection of life and health of the person according to the prevention of actions of the misleading consumers, concerning safety in case of storage of medicines and observance of the sanitary mode of drugstores.

3. Subjects to regulation of the Technical regulation are processes of storage of various groups of medicines and organizational measures for safety in case of storage of medicines in the pharmaceutical organizations and the organizations of health care, and also health requirements to the pharmaceutical organizations. Requirements of the Technical regulation are obligatory for all organizations of health care and the pharmaceutical organizations irrespective of pattern of ownership and departmental accessory (further - the pharmaceutical organizations).

4. In the Technical regulation the following terms and concepts are applied:

1) the Asepsis - conditions and complex of the actions directed to prevention of microbic and other pollution in case of receipt of sterile products at all stages of engineering procedure.

2) the Aseptic block - the drugstore territory which is specially designed, equipped and used so that to reduce penetration, education and delay in it microbiological and other pollution.

3) the State pharmacopeia - the collection of pharmakopeyny Articles.

Before creation of the State pharmacopeia of the Kyrgyz Republic in the territory of the Kyrgyz Republic are applied: State pharmacopeia of the USSR IX, X, XI editions, International pharmacopeia, pharmacopeias of the USA (USP) and Germany (DAB), European pharmacopeia (EP), British pharmacopeia (BP).

4) the Group container - the packaging uniting certain amount of medicines, products of medical appointment, medical equipment in consumer packaging.

5) Expiry date of the validity - the date specified on individual packaging (usually on the label) medicine to which (inclusive) medicine shall meet specifications on condition of the correct storage. For each batch this date is determined by summing of storage duration and date of production.

6) Disinfection - process of killing on product either in product, or on surface of pathogenic species of microorganisms (thermal and chemical methods and means).

7) Pollution - undesirable entering of impurity of chemical or microbic origin or alien substances into initial material or intermediate or final product in the course of production, sampling, packagings or repackings, storages or transportations.

8) Marking - selection process of the correct label with all necessary information with the subsequent verification and accession of the label.

9) Material(s) - the general term applied to designation of initial material (active pharmaceutical ingredients and excipients), reagents, solvents, intermediate products, packaging material and labels.

10) the Responsible person for quality - person responsible for quality assurance in case of organization activity implementation.

11) Cross contamination - pollution of initial material, intermediate product or final product other initial material, or product in production process.

12) Rooms of storage - specially allocated and equipped production rooms intended for storage of medicines, products of medical appointment and medical equipment.

13) the Supplier - person providing delivery of pharmaceutical products on demand. Agents, intermediaries, distributors, producers or sellers can be suppliers. As a rule, suppliers shall be authorized by competent authorities.

14) Presterilizing processing - removal of proteinaceous, fatty, mechanical pollution, residual amounts of medicinal substances. Sink and moyushche-disinfecting processing of products and objects determines efficiency of sterilization, reduces risk of pyrogene reactions at the patient.

15) Psychotropic substances - the substances influencing the mental activities, emotional condition and behavior of the person included in the list constituted and updated according to the Convention on psychotropic substances of 1971 and the legislation of the Kyrgyz Republic.

16) Sanitary clothes - the scrub, hat and bandage intended for protection of medicines, materials and finished goods against the additional microbiological and other pollution allocated by personnel.

17) medicine Expiration date - time established for use of medicines during which their safety, efficiency and proper quality in case of observance of storage conditions according to requirements of regulatory legal acts is guaranteed.

18) Sterilization - process of killing on products or in products, or removal from object of microorganisms of all types which are at all stages of development including disputes (thermal and chemical methods and means).

19) the Sticker (sticker) - the additional label on packaging containing information on medicine in the state and Russian languages.

20) the Transport container - the container forming independent transport unit.

21) medicine Packaging - means or complex of the means providing their protection against damages and losses.

Packaging consists of primary (internal) and secondary (external) package:

- primary (internal) package is the packaging which is directly adjoining to dosage form;

- secondary (external) package is packaging in which medicine in primary package is located.

22) the Packaging material - material, including printing, applied to packaging of pharmaceutical products, excepting external packaging for transportation and loading. The packaging material can be primary or secondary, depending on whether it enters direct contact with product.

23) Storage of medicines - process of placement (warehousing) of products with providing storage conditions from the moment of receipt and until obtaining by the consumer.

24) Storage in the dark place - storage of medicines, products of medical appointment in the place protected from sunlight.

25) Storage in the dry place - storage of medicines, products of medical appointment, medical equipment in rooms with relative humidity of air no more than 60 percent.

26) Storage in the cool place - storage of medicines, products of medical appointment, medical equipment at temperature from +8 to +15 °C.

27) Storage at the room temperature - storage of medicines, products of medical appointment, medical equipment at temperature from +15 ° to +25 °C (including if temperature is not specified).

28) the Refrigerating element (further - hladoelement) - plastic or squared metal reservoir with airtight stopper for filling with water which is refrigerated before use and serves for maintenance of temperature in container ranging from +2 °C to +8 °C.

29) the Thermal container - box (or bag) for transfer of medicines, the products of medical appointment requiring protection against impact of the increased temperature with the heat-insulating properties and skintight cover where optimum temperature condition (from + 2 °C to + 8 °C) is provided by means of the refrigerated refrigerating elements placed in his cavity.

Contents of other terms are determined by separate Items of this technical regulation.

Chapter 2. General requirements of safety to storage of medicines

§ 1. Safety requirements to the device and operation of rooms for storage of medicines

5. The technical regulation establishes safety requirements to stores organization of various groups of medicines in the pharmaceutical organizations and the organizations of health care.

6. The device, structure, the sizes of the areas and the equipment of rooms of storage of medicines shall meet all requirements of the specifications and technical documentation.

The device, operation and the equipment of rooms of storage shall ensure safety of medicines.

7. Rooms of storage according to the established regulations are provided with security and fire-proof means.

8. Certain temperature and humidity of air which check shall be performed at least 1 time a day shall be maintained in rooms of storage. For observation of these parameters storage facilities need to be provided with thermometers and hygrometers which are fixed on internal walls of storage, far from heating devices, at m 1,5-1,7 height from floor and at distance at least 3 meters from doors. Indications of these devices without fail are subject to registration according to appendix 1 to the Technical regulation.

9. For maintenance of purity of air of the room of storage according to the existing specifications and technical documentation it is necessary to equip with supply and exhaust ventilation with mechanical motivation. In case of impossibility of the equipment of rooms of storage the supply and exhaust ventilation recommends to equip window leaves, transoms, the second trellised doors, etc.

10. Pharmaceutical warehouses and drugstores are equipped with devices of central heating. Heating of rooms by gas devices with open flame or electric heaters with open electrospiral is not allowed.

11. In warehouses and in the drugstores located in climatic zone with big variations from admissible regulations of temperature and relative humidity of air, rooms of storage shall be equipped with conditioners.

12. Rooms of storage shall be provided with necessary quantity of racks, cases, pallets, podtovarnik, etc.

Installation of racks is performed so that they were at m 0,6-0,7 distance from external walls, m 0,5 from ceiling of at least 0,25 of m from floor suffices. Racks in relation to windows shall be located so that passes were lit, and the distance between racks made at least 0,75 of m and provided open entry to goods.

13. Premises of pharmaceutical institutions shall be kept clean; floors of rooms periodically (but at least once a day) shall clean up by damp method using the permitted detergents.

§ 2. General requirements to stores organization of medicines

14. Medicines in rooms of storage need to be placed taking into account the most complete space occupancy, creation of the best working conditions for employees of the pharmaceutical organizations, possibility of application of means of mechanization and providing pharmaceutical procedure.

15. Medicines should be placed on racks, in cases, and if necessary on floor, previously having enclosed the pallet, podtovarnik, special plate, etc.

16. In rooms of storage medicines place separately:

1) in strict accordance with toxicological groups;

2) poisonous and strong medicines shall be stored according to the existing requirements;

3) according to pharmacological groups, when using modern technologies other procedure for placement of medicines is allowed (alphabetically, to codes, etc.);

4) depending on method of application (internal, external);

5) the medicinal substances "angro" according to aggregate state (liquid separately from loose, gaseous, etc.);

6) according to physical and chemical properties of medicines and influence of various factors of external environment;

7) taking into account fixed terms of storage for medicines with limited expiration dates;

8) taking into account nature of various dosage forms.

17. It is not recommended to have row medicines, conformable according to the name, medicines for internal application with strongly differing highest doses, and also to have them in alphabetical order (when using modern technologies other procedure for placement of medicines and (alphabetically, to codes, etc. is allowed) after additional coordination with authorized state body in the field of health care of the Kyrgyz Republic.

18. In the course of storage it is necessary to exercise continuous visual inspection over container condition, external changes of medicines at least once a month. In case of damage of container without fail to eliminate its defects or to shift content in other container. In case of external changes of medicines control of their quality according to requirements of the regulating documentation is carried out and their suitability to use in accordance with the established procedure is determined.

19. In rooms of storage, and also in the territory of warehouse it is necessary to hold systematically events for fight against rodents, insects and other wreckers.

§ 3. The safety requirements imposed to storage of various groups of medicines

20. Medicines depending on physical and physical and chemical properties of impact on them various factors of external environment divide into the following groups:

1) the requiring protection against light;

2) the requiring protection against moisture impact;

3) the requiring protection against volatilization and drying;

4) the requiring protection against impact of the increased temperature;

5) the requiring protection against the lowered temperature;

6) the requiring protection against impact of the gases containing in the environment;

7) odorous, painting;

8) disinfectants.

21. Features of storage of the medicines requiring protection against light.

Treat group of the medicines requiring protection against light: antibiotics, galenovy medicines (tinctures, extracts, concentrates from vegetable raw materials), vegetable medicinal raw materials, organopreparata, vitamins and vitamin medicines; corticosteroids, essential oils, fat oils, drazhirovanny medicines, salts of iodide and hydrobromic acids, galogenozameshchenny connections, nitro - and nitrozosoyedineniye, nitrates, nitrites, amino-and the amidoconnections, phenolic connections derivative of fenotiazin (The list of the medicines which are subject to storage in the place protected from light is given in appendix 2 to the Technical regulation).

22. The medicines requiring protection against effect of light should be stored in container from light-protective materials (glass container from orange glass, metal container, packaging from the aluminum foil or polymeric materials painted in black, brown or orange colors), in the dark room or cases painted inside by black paint with densely driven doors or in strong boxes with densely driven cover.

23. For storage of medicinal substances, especially sensitive to light (silver nitrate, prozerin, etc.) the glass container is pasted over with black lightproof paper. The medicinal substances needing light impact (medicines of zakisny iron) should be stored in glass container of small reservoir from light glass on bright to light. Impact of direct sunshine is allowed.

24. Features of storage of the medicines requiring protection against moisture impact.

Treat group of the medicines requiring protection against moisture impact: hygroscopic substances and medicines (for example, potassium acetate, dry extracts, vegetable medicinal raw materials, the hydrolyzed substances, salts nitric, nitrogenous, galogenovodorodny and phosphoric acids, salt of alkaloids, sodium metalloorganic connections, glycosides, antibiotics, enzymes, dry organopreparata), the medicinal substances characterized in pharmakopeyny Article as "very easily soluble in water" and also medicinal substances which moisture content shall not exceed the limit set by the regulating documentation and the medicinal substances which are oxidized air oxygen (The list of the medicines requiring protection against moisture impact is given in appendix 3 to the Technical regulation).

25. The medicines requiring protection against impact of atmospheric vapors of water should be stored in the cool place, in densely corked container from materials, impervious for water vapors (glass, metal, aluminum foil), in thick-walled plastic container.

26. Medicines with the expressed hygroscopic properties should be stored in the dry room in glass container with the hermetic packing which is filled in from above with paraffin. When closing container with such medicinal substances it is necessary to wipe throat and stopper carefully.

27. The medicines requiring protection against moisture impact, received in packaging from polymeric film and intended for supply of the pharmaceutical organizations should be stored in original packing or to restack in glass or metal container.

28. The special attention is required by stores organization of such medicines as plaster burned and mustard in powder which in case of absorption of moisture turn from small amorphous powder into fine grains - lose the qualities and become unsuitable for application in the medical purposes.

In order to avoid spoil:

1) plaster burned should be stored in well closed container (in strong wooden boxes or kegs, it is desirable laid out from within by polyethylene film);

2) mustard should be stored in powder in hermetically the closed cans varnished from within;

Mustard plasters store 3) in the packs packed into glassine paper or polyethylene film which place in densely corked container (the cardboard boxes which are pasted over from within with polymeric film).

29. Features of storage of the medicines requiring protection against volatilization and drying.

Treat the medicines requiring protection against volatilization and drying:

1) actually volatiles (The list of the medicines having flying properties is given in appendix 4 to the Technical regulation);

2) the medicines containing flying solvent (spirit tinctures, liquid spirit concentrates, dense extracts);

3) solutions and mixes of volatiles (essential oils, solutions of ammonia, formaldehyde, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentration, etc.);

4) the medicinal vegetable raw materials containing essential oils;

5) the medicines containing crystallizational water - crystalline hydrates;

6) the medicinal substances decaying with formation of flying products (iodoform, hydrogen peroxide, chloroamine B, sodium hydrocarbonate);

7) medicinal substances with the lower limit of moisture content (magnesium sulfate, sodium paraaminosalycylate, sodium sulfate, etc.) set by the regulating documentation.

30. The medicines requiring protection against volatilization and drying should be stored in the cool place, in hermetically the corked container from impervious for the disappearing substances of materials (glass, metal, aluminum foil). Application of polymeric container, packaging and packing is allowed according to the regulating documentation.

31. Crystalline hydrates, depending on relative humidity of air, can show property both the hygroscopic, and disappearing substances. Therefore they should be stored in hermetically the corked glass, metal or thick-walled plastic container in case of relative humidity of air of 50-65% in the cool place (The list of the medicines containing crystallizational water is given in appendix 5 to the Technical regulation).

32. Features of storage of the medicines requiring protection against impact of the increased temperature.

Treat the medicines requiring protection against impact of the increased temperature:

1) group of the medicinal substances requiring protection against volatilization and drying (Item 29 of the Technical regulation);

2) fusible substances;

3) immunobiological medicines;

4) antibiotics;

5) organopreparata;

6) hormonal medicines;

7) vitamins and vitamin medicines;

8) the medicines containing glycosides;

9) medical fats and oils;

10) ointments on fatty basis and other substances.

33. The medicines requiring protection against impact of the increased temperature should be stored in case of room (18 - 20 °C), cool (or cold) - (12-15 °C) temperature. In certain cases lower temperature of storage is required (for ATP - 3-5 °C) that shall be specified on the label or in the instruction for use of medicine.

34. Immunobiological medicines should be stored in industrial package separately according to names, at temperature specified for each name on the label or in the instruction for application.

35. Immunobiological medicines of the same name store on series, taking into account the term of their validity.

36. Immunobiological medicines should be subjected in the course of storage to visual inspection at least, than once a month.

37. Antibiotics should be stored in industrial package at the room temperature if there are no other instructions on labels.

38. Organopreparata it is necessary to store in the protected from light, cool and dry place at temperature of 0 ±15 °C if there are no other instructions on labels or in the instruction for application.

39. Features of storage of the medicines requiring protection against impact of the lowered temperature.

Treat group of the medicines requiring protection against impact of the lowered temperature such which physical and chemical condition after freezing changes and in case of the subsequent warming to room temperature it is not recovered (40% formaldehyde solution, insulin solutions, etc.) (The list of the medicines requiring protection against impact of the lowered temperature is given in appendix 6 to the Technical regulation).

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