RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of October 17, 2024 No. 627

About approval of the Procedure for production of medicines in drugstores

For the purpose of implementation of article 25 of the Law of the Kyrgyz Republic "About drug circulation", according to articles 13, of the 17th constitutional Law of the Kyrgyz Republic "About the Cabinet of Ministers of the Kyrgyz Republic" the Cabinet of Ministers of the Kyrgyz Republic decides:

1. Approve the Procedure for production of medicines in drugstores according to appendix.

2. Declare invalid the order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of the Medicines Made in Drugstores" of May 26, 2012 No. 320.

3. This resolution becomes effective after fifteen days from the date of official publication.

Appendix

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of October 17, 2024 No. 627

Procedure for production of medicines in drugstores

Chapter 1. General provisions

1. The procedure for production of medicines in drugstores (further - the Procedure) is applied for the purpose of safety of medicines and protection of life and health of the person, the prevention of the actions misleading consumers concerning safety in case of production of medicines in drugstores.

2. This Procedure determines mandatory requirements to the medicines produced in drugstores with the production right (further - drugstore), and governs the relations arising in the course of their production.

3. Subjects to regulation of this Procedure are:

1) the medicines made in drugstores;

2) processes of production of medicines in drugstores;

3) the rooms and the equipment used for production of medicines in drugstores.

4. Requirements and provisions of this Procedure do not extend to finished pharmaceutical products of industrial production, and also the medicines used in veterinary science.

5. This Procedure establishes:

1) requirements to safety of medicines in the course of production;

2) rules and forms of assessment of conformity of medicines;

3) requirements to packaging and marking of the medicines produced in drugstores.

6. In this Procedure the following terms and concepts are applied:

1) 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) disinfection - process of killing on product either in product, or on surface of pathogenic species of microorganisms (thermal and chemical methods and means);

3) liquid dosage forms - the medicines received by mixing or dissolution of active ingredients in the solvent and also by extraction of active ingredients from plant material. Liquid dosage forms divide into medicines for external application, medicines for internal application and medicines for injection application;

4) indicators - chemicals which in case of titrimetrichesky methods of the analysis allow to find out that to titrable solution the equivalent quantity of titrant is added;

5) drops eye - the dosage form intended for instillation in eye;

6) the concentrated solutions (concentrates) - in advance made solutions of medicinal substances of higher concentration, than concentration in which these substances write out in recipes;

7) marking - selection process of the correct label with all necessary information with the subsequent verification and accession of the label;

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

9) ointments - the soft dosage form intended for drawing on skin, wounds or mucous membranes;

10) mechanical inclusions - foreign mobile insoluble substances, except gas bubbles, accidentally present at solutions;

11) masso-volume concentration - amount of medicinal substance (in grams) in total amount of liquid dosage form (in milliliters); concentration on weight - amount of medicine or individual substance (in grams) in the lump of liquid dosage form (in grams); volume concentration - amount of liquid medicine or individual substance (in milliliters) in total amount of liquid dosage form (in milliliters);

12) molyarnost of solution (mol/l) is the amount of dissolved substance expressed in moths containing in one liter of solution. The Molyarnost is calculated as the relation of amount of dissolved substance to solution amount;

13) normal concentration - the number of grams equivalents of the substance containing in 1 l of solution. Normal concentration is expressed in mol-ekv/l or use reducing "N";

14) infusions and broths - the liquid dosage forms representing water extraction from medicinal vegetable raw materials and also water solutions of dry or liquid extracts (concentrates);

15) powders - the firm dosage form for internal and external application which is consisting of one or several crushed substances and having property of flowability;

16) syrups - the concentrated water solutions of sucrose which may contain medicinal substances, fruit food extracts;

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

18) suspensions - the liquid dosage form containing in quality of disperse phase one or several crushed powdery medicinal substances;

19) suppositories - firm at the room temperature and melting or the dosed dosage forms which are dissolved in case of body temperature;

20) titrovanny solutions (titrant) - the solutions of precisely known concentration intended for the purposes of the volume analysis;

21) trituration are the in advance prepared mixes of psychotropic, narcotic or toxic agents (it is less than 0,05 of) with indifferent substances (dairy sugar in the ratio 1:1000 or 1:10);

22) authorized body - subordinated division of authorized state body in health sector on regulation of the sphere of drug circulation and medical products;

23) storage - condition of pharmaceutical products under certain conditions and places until its use;

24) extracts - the concentrated extraction from medicinal vegetable raw materials;

25) emulsions - the dosage form, uniform in appearance, consisting of mutually insoluble thinly dispersed liquids, intended for internal, external or parenteral application.

Chapter 2. Safety requirements in case of pharmaceutical production of medicines

7. Production of medicines is performed in the drugstore having the license for production and realization of medicines by rules of production of the liquid medicines containing in appendix 1 to this Procedure.

In the presence of the license the authorized body approves the nomenclature of intra pharmaceutical procurement of the medicines made in drugstores for a period of 1 year.

8. Production of medicines in drugstores is performed according to individual recipes of doctors (ex-temporal medicines) and on standard copy-books (official medicines) according to the nomenclature of the intra pharmaceutical procurement approved by authorized body on the basis of the pharmaceutical substances registered in the Kyrgyz Republic.

9. In case of production of medicines in the conditions of drugstore requirements of regulatory legal acts of the Kyrgyz Republic and the pharmacopeias permitted by the Law of the Kyrgyz Republic "About the address medicines" shall be fulfilled (further - pharmacopeias).

10. General requirements on safety of medicines in case of their production:

1) respect for sanitary standards and rules, the anti-epidemic mode, and also conditions of aseptic production of the medicines which are kept in this Order;

2) observance of rules of obtaining, collection and storage of the water purified waters for injections, timely sanitary processing of the pipeline, control of timely withdrawal of sterile solutions, the water purified, waters for injections for testing for sterility according to the approved regulatory legal acts.

Collections for the water purified, water for injections shall have accurate text: "The water purified", "Water for injections". On the collection of water the label with indication of date of its obtaining, number of the analysis and the signature of checked is attached. In case of simultaneous use of several collections they shall be numbered;

3) ensuring serviceability and accuracy of the devices, devices and weight economy specified in the List of measuring instruments, the test equipment, laboratory glassware, auxiliary materials, tools, the devices used to analytical works in drugstores (appendix 2 to this Procedure) and regularity of their checking;

4) careful survey of the recipes arriving in drugstore and requirements of the organizations of health care for the purpose of check of correctness of their writing out, compatibility of the substances which are part of medicines, compliance of the registered doses to age of the patient and availability of instructions about methods of application of medicines;

5) respect for technology of medicines (including homeopathic) according to requirements of regulatory legal acts, methodical instructions;

6) providing in drugstore of storage conditions of medicines according to their physical and chemical properties and requirements of regulatory legal acts;

7) in rooms of storage on all shtanglasa with medicinal substances number of series of the organization manufacturer, certificate number of the compliance issued by authorized body, expiration date, date of the filling and the signature which filled shtanglas shall be specified. On shtanglasa with the medicines containing warm glycosides the quantity of units of action in one gram of medicinal vegetable raw materials or in one milliliter of medicine shall be specified;

8) in assistant rooms on all shtanglasa with medicinal substances shall be specified: date of filling, the signature of the medicinal substance which filled shtanglas and verified authenticity. On shtanglasa with toxic, narcotic and psychotropic medicinal agents the highest one-time and daily doses shall be specified, and on shtanglasa with the medicinal substances intended for production of sterile dosage forms there shall be warning label "For Sterile Dosage Forms";

9) shtanglasa with solutions, tinctures and liquid semifinished products shall be provided with normal kaplemer or pipettes. The number of drops in certain amount shall be determined by weighing and is designated on shtanglasa;

10) filling of shtanglas, the burette in byuretochny installation, shtanglas with kaplemer or pipette shall be carried out only after complete use of medicine and the corresponding processing of shtanglas;

11) the nomenclature of concentrates, semifinished products and intra pharmaceutical procurement of the medicines produced in drugstores affirms authorized body on representation of drugstore. Only the copy-books containing compatible medicinal substances on which there are analysis techniques for chemical control are included in this list;

12) heads of drugstores of the organizations of health care need to exercise once in quarter control of observance of storage precautions of medicines in departments of the organizations of health care.

In departments of the organizations of health care production of medicines, packing, movement from one reservoir (packaging) to another and replacement of labels is not allowed. Medicines shall be stored in departments only in original (factory, factory or pharmaceutical) packaging;

13) for control of expiration date on packaging of the packing released by drugstore in the organizations of health care shall be designated date of production, the expiration date specified in the certificate of the organization manufacturer;

14) medicines shall be provided from drugstores in the organization of health care only to authorized medical personnel on demand;

15) production of fragrant waters, intra pharmaceutical procurement of the medicines for external application containing tar, Ichthyol, sulfur, the Naftalan oil, collodion, lead water and also homeopathic medicines which analysis cannot be performed in the conditions of drugstore is made under observation of the druggist occupied with quality control of medicines.

11. Realization of the medicines made in drugstores shall be performed in department of finished pharmaceutical products of production drugstore.

Chapter 3. Control of production of medicines in drugstore

§ 1. Forms of quality control of the medicines made in drugstores

12. Control in case of production (intra pharmaceutical control) is carried out by specialists of drugstores according to the obligations assigned to them.

Control in case of production (intra pharmaceutical control) is carried out in type:

1) acceptance review;

2) written control;

3) polling control;

4) organoleptic control;

5) physical control;

6) chemical control.

The druggist exercising quality control of the medicines made in drugstores (further - the druggist-analyst), shall own professional knowledge in the field of intra pharmaceutical control.

13. Intra pharmaceutical control provides the actions providing production in drugstores of medicines which quality conforms to the requirements regulated by regulatory legal acts of the Kyrgyz Republic and pharmacopeias.

14. Medicinal substances irrespective of source of their receipt are exposed to acceptance review according to requirements of this Procedure.

15. The medicines made in drugstores (including homeopathic) according to individual recipes or requirements of the organizations of health care, in the form of intra pharmaceutical procurement, packing, and also concentrates and semifinished products are exposed to intra pharmaceutical control: written, organoleptic and to control in case of leave - it is obligatory; polling and physical - selectively; to chemical - according to requirements of this Procedure.

16. The head of drugstore and his deputies should provide conditions of accomplishment of the corresponding types of control according to this Procedure.

§ 2. Acceptance review

17. Acceptance review is carried out by the druggist responsible for acceptance review, for the prevention of receipt to drugstore of low-quality medicines.

18. Acceptance review consists in check of the arriving medicines on compliance to requirements for indicators "Description", "Packaging", "Marking", correctness of execution of settlement documents (accounts), and also availability of the certificates of conformity issued by authorized body.

Control on indicator "Description" includes check of appearance, color, smell. In case of doubt in quality of medicines samples go to authorized body. Such medicines with designation: "Quarantine" is stored in drugstore separately from other medicines.

When checking on indicator "Packaging" special attention is paid on its integrity and compliance to physical and chemical properties of medicines.

In case of control on indicator "Marking" the attention to compliance of registration of medicines to requirements of the current legislation is paid.

19. Special attention should be paid on compliance of marking of primary, secondary and group package, leaflet insert availability in the state and/or official language in packaging (or separately in pack on all quantity of finished pharmaceutical products).

20. On labels of packaging with the medicinal substances intended for production of solutions for injections and infusions there shall be specifying "It Is Suitable for Injections". Packagings with poisonous and narcotic medicines shall be drawn up according to requirements of the legislation of the Kyrgyz Republic.

21. The medicinal vegetable raw materials which arrived from the population are checked on indicator "External signs" according to requirements of pharmacopeias then goes to the analysis to authorized body.

§ 3. Written control

22. Production of medicines in drugstore is performed by the druggist-technologist performing control functions in case of production and leave of medicines.

23. In case of production of dosage forms according to recipes and requirements of the organizations of health care the druggist-technologist fills in passports of written control. In the passport date of production, number of the recipe (the name of the organization of health care, the name of department), the name of the taken medicinal substances and their quantity, number of doses, the signatures which made, packed up and checked dosage form shall be specified.

24. Calculations of quantitative content of the medicines and excipients which are part of dosage form shall be made before production of dosage form and register on reverse side of the passport. The passport is filled in immediately after production of dosage form in Latin according to the sequence of technological transactions. When filling the passport of homeopathic dosage forms homeopathic names of consistently taken medicines are specified.

In case of use of semifinished products and concentrates in the passport their structure, concentration, the taken amount or weight is specified. In case of production of powders, suppositories and pills the lump, quantity and mass of separate doses is specified. Lump of pills or suppositories, concentration and amount (or weight) the isotinting and stabilizing substances added to eye drops, solutions for injections and infusions shall be specified not only in passports, but also on recipes.

In the passport it is necessary to specify formulas of calculation and water absorption coefficients used at the same time for medicinal vegetable raw materials according to appendix 3 to this Procedure, coefficients of increase in amount of solutions in case of dissolution of medicinal substances according to appendix 4 to this Procedure, replacement coefficients in case of production of suppositories.

25. Maintaining passports of written control is also necessary if dosage forms are made and released by the same person. In this case the passport is filled in in the course of production of dosage form.

26. Passports of written control remain in drugstore within two months from the moment of medicine production.

27. The made medicines, recipes and the completed passports are transferred to check to the druggist-technologist. Control consists in check of compliance of entries in the passport of written control of copy-book in the recipe, correctness of the made calculations. If complete chemical quality control of medicine by the druggist-analyst is carried out, then on the passport number of the analysis and the signature of the druggist-analyst is put down.

28. The made concentrates, semifinished products, intra pharmaceutical procurement and packing of medicines are subject to registration in accordance with the established procedure according to appendix 5 to this Procedure.

§ 4. Polling control

29. Polling control is applied selectively. No more than five dosage forms, and immediately after preparation of drugs for the injections and drugs containing psychotropic, narcotic substances are carried out after production by the druggist-technologist.

30. When carrying out polling control the druggist performing control functions calls the first substance entering dosage form, and in dosage forms of complex structure specifies also its quantity then the druggist-technologist calls all taken medicinal substances and their quantity. When using semifinished products (concentrates) the druggist-technologist calls also their structure and concentration.

§ 5. Organoleptic control

31. Organoleptic control is carried out by the druggist-technologist who consists in check of dosage form (including homeopathic) on indicators: "Description" (appearance, color, smell), uniformity, lack of visible mechanical inclusions (in liquid dosage forms). All dosage forms intended for children are checked for taste.

32. Uniformity of powders, homeopathic trituration, ointments, pills, suppositories is checked according to requirements of regulatory legal acts and pharmacopeias. Check is performed selectively at each druggist during the working day taking into account different types of dosage forms.

Results of organoleptic control of dosage forms are subject to registration in accordance with the established procedure according to appendix 6 to this Procedure.

§ 6. Physical control

33. Physical control is carried out by the druggist-technologist and consists in check of lump or amount of dosage form, quantity and mass of separate doses (at least three doses) entering this dosage form.

34. Are exposed to physical control:

1) each series of packing and intra pharmaceutical procurement in number of at least three packagings (including packing of industrial output and homeopathic medicines);

2) the dosage forms made according to individual recipes, requirements, selectively during the working day taking into account different types of dosage forms, but at least 3% of quantity of the dosage forms made in day;

3) each series of the dosage forms requiring sterilization after packing before their sterilization in number of at least five bottles (bottles);

4) quantity of homeopathic granules in certain mass of hinge plate according to requirements of regulatory legal acts.

When checking dosage forms also quality of packing is controlled.

35. Results of physical control are subject to registration in accordance with the established procedure, according to appendix 6 to this Procedure.

§ 7. Chemical control

36. Chemical control of the made medicines in drugstore is carried out by the druggist-analyst and consists in quality evaluation of production of medicine on indicators: "Authenticity", "Quantitative determination" (quantitative analysis) of medicinal substances, being its part.

37. Are exposed to qualitative analysis:

1) the water purified, water for injections - daily (from each cylinder, and in case of water supply on the pipeline - on each workplace) on lack of chlorides, sulfates and salts of calcium. The water intended for production of sterile solutions except the testing stated above, shall be checked for lack of the recovering substances, salts of ammonium and carbon of dioxide according to the established requirements.

Quarterly the water purified, water for injections shall go to authorized body for the complete chemical and microbiological analysis;

2) all medicines, concentrates and semifinished products (including homeopathic tinctures, trituration, solutions, cultivations) arriving from placements of storage to the assistant room, and in case of doubt - the medicines arriving in drugstore from warehouse;

3) concentrates, semifinished products and liquid medicines in byuretochny installation and in shtanglasa with pipettes - in the assistant room when filling;

4) the medicines of industrial production which are packed up in drugstore and the intra pharmaceutical procurement made and which is packed up in drugstore (each series).

38. Are exposed to qualitative analysis selectively:

1) the dosage forms made according to individual recipes and requirements of the organizations of health care at each assistant to the druggist during the working day, but at least 10% of total quantity of the made dosage forms. Different types of dosage forms shall be exposed to check.

Special attention is paid on the dosage forms for children applied in eye practice, containing narcotic and toxic agents;

2) the homeopathic cultivations of the fourth decimal cultivation containing toxic, psychotropic and narcotic biologically active agents or inorganic and organic compounds.

39. Results of qualitative analysis are subject to registration in accordance with the established procedure, according to appendices 6, of 7, 8 to this Procedure.

40. Are exposed to qualitative and quantitative analysis (complete chemical control) without fail:

1) solutions for injections and infusions before sterilization, including determination of the size pH, the isotinting and stabilizing substances.

Solutions for injections and infusions after sterilization are verified at size pH, authenticity and quantitative content of active ingredients. For control after sterilization one bottle of solutions from each series is selected.

Stabilizers in these solutions after sterilization are checked in the cases provided by regulating documents, including methodical instructions;

2) sterile solutions for external application (ophthalmologic solutions for irrigations, solutions for treatment of burn surfaces and open wounds, for intravaginalny introduction and others);

3) the eye drops and ointments containing narcotic and toxic agents. In the analysis of eye drops content in them the isotinting and stabilizing substances is determined before sterilization (appendix 11 to this Procedure);

4) dosage forms for newborn children;

5) solutions of atropine of sulfate and acid chlorohydrogen (for the internal use), solutions of mercury of bichloride and silver of nitrate;

6) concentrates, semifinished products, trituration, including liquid homeopathic cultivations of inorganic and organic medicinal substances and their trituration before the third decimal cultivation;

7) intra pharmaceutical procurement of medicines (each series);

8) the stabilizers used in case of production of solutions to injections and the buffer solutions applied in case of production of eye drops;

9) concentration of alcohol ethyl in case of cultivation in drugstore, and in case of need - in case of acceptance from warehouse (for refining of amount of waterless alcohol);

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