ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of January 16, 2012 No. 60

About approval of Rules of production of medicines and products of medical appointment

According to article 68 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Rules of production of medicines and products of medical appointment.

2. This resolution is entered after ten calendar days after the first official publication.

Approved by the order of the Government of the Republic of Kazakhstan of January 16, 2012 No. 60

Rules of production of medicines and products of medical appointment

1. General provisions

1. These rules of production of medicines and products of medical appointment (further - Rules) determine procedure for production of medicines and products of medical appointment.

2. Production of medicines and products of medical appointment is performed by the subjects in the field of drug circulation, products of medical appointment having the corresponding license for production of medicines and products of medical appointment.

3. In these rules the following concepts are used:

1) production of medicines - the pharmaceutical activities connected with production of dosage forms in drugstores and also with acquisition of medicinal substances, storage, quality control, registration and realization of the made medicines;

2) production of products of medical appointment - the pharmaceutical activities connected with production of products of medical appointment in drugstores, shops of medical equipment and products of medical appointment and shops of optics;

3) proper production practice - the national standard in the field of drug circulation, products of medical appointment and medical equipment establishing requirements to production organization, production process and monitoring procedure in case of production of medicines, products of medical appointment and medical equipment;

4) sterile medicines - the medicines in certain dosage form which underwent process of sterilization on lack of live organisms.

4. Production of medicines and products of medical appointment is performed on the basis of the medicines registered in the Republic of Kazakhstan, except for medicinal substances, made in the conditions of the Proper production practice.

5. Manufacturing techniques of the medicines and products of medical appointment made in the conditions of drugstore of shop of medical equipment and products of medical appointment and shop of optics are performed according to requirements of general clauses of the State pharmacopeia of the Republic of Kazakhstan, individual pharmacopoeian clauses, foreign pharmacopeias, acknowledged acting in the territory of the Republic of Kazakhstan, the regulating documents approved by authorized body in the field of health care.

6. In the medical organizations which do not have as a part of drugstore with the right of production of medicines production and (or) packing of medicines, restacking of medicines from one packaging in another, replacement of labels is not allowed.

2. Procedure for production of medicines

7. Medicines are made taking into account the following conditions:

1) observance of rules of writing out of recipes, compliance of the registered doses to age of the patient, regulations of one-time leave, compatibility of the ingredients which are part of medicine;

2) observance of manufacturing techniques of medicines;

3) providing medicine with the corresponding marking and packaging;

4) ensuring proper leave of medicine with provision to the patient of the objective information about medicines available concepts and councils on their application and storage.

8. Production of medicines is performed:

1) according to recipes of doctors;

2) according to requirements of the medical organizations;

3) in the form of intra pharmaceutical procurement;

4) packings of medicines and medicinal vegetable raw materials.

9. In case of production of medicines variations, within regulations, admissible are allowed in case of production of medicines (including homeopathic) in drugstore, admissible when packing industrial output in drugstore, admissible error in case of measurement of size of acid-base balance according to appendices 1, of 2, 3 to these rules.

10. Conditions of sterilization, storage and expiration dates of the medicines made in drugstore are established according to appendix 4 to these rules.

11. In the medical organizations medicines from drugstore shall be released only to authorized medical personnel by proxy, drawn up according to the procedure established by the legislation of the Republic of Kazakhstan.

2.1. Procedure for production of sterile medicines

12. In aseptic conditions make:

1) medicines for newborns;

2) solutions for injections and infusions;

3) the irrigational solutions entered into the cavities which are not containing microorganisms;

4) liquid medicines for newborns and children up to one year;

5) the medicines in the form of liquid dosage form containing antibiotics and other antimicrobic substances, and also intended for drawing on wounds and burn surfaces;

6) drops eye, ophthalmologic solutions for irrigations and lotion;

7) the concentrated solutions (including homeopathic cultivations);

8) liquid medicines in the form of intra pharmaceutical procurement.

13. Are not allowed:

1) production of sterile medicines in the absence of data on chemical compatibility of the medicinal substances entering them, technology and the mode of sterilization;

2) simultaneous production on one workplace of several sterile solutions containing medicinal substances with different names or one name, but in different concentration.

14. Results of control of separate stages of production of solutions for injections and infusions are registered in the magazine of registration of results of control of separate stages of production of solutions for injections and infusions in the enclosed form according to appendix 5 to these rules. The magazine shall be numbered, strung together, certified by the signature of the head of drugstore and is under seal drugstores.

15. Control of sterile solutions on lack of mechanical inclusions is carried out before sterilization.

It is necessary to check amount of solutions in bottles (bottles) and quality of their packing (the metal cap "under running in" shall not be scrolled when checking manually, solution shall not pour out when capsizing bottle (bottle).

16. Bottles with solutions after packing are marked by text, stamping on cover or with use of metal counters with indication of the name and concentration.

17. Sterilization of solutions shall be carried out no later than three hours from the beginning of production, under control of the specialist (the druggist or the pharmacist).

Repeated sterilization of solutions is not allowed.

Registration of parameters of sterilization is made in the magazine of registration of the mode of sterilization of initial medicinal substances, the made medicines, auxiliary materials, ware in form according to appendix 6 to these rules. The magazine shall be numbered, strung together, certified by the signature of the head of drugstore and is under seal drugstores.

18. The nomenclature of concentrates, semifinished products and intra pharmaceutical procurement of the medicines produced in drugstore annually affirms accredited test laboratory with which the agreement on control and analytical servicing is signed. Include the medicines containing compatible active and excipients on which there are analysis techniques for complete chemical control with fixed terms of the validity in this list.

3. Procedure for production of products of medical appointment

19. Products of medical appointment are made taking into account the following conditions:

1) in case of their use to destination (in case of operation) according to the instructions and information represented by the manufacturer of products they ensured safety and did not put at risk the state of health of patients, users or other persons;

2) preserving their characteristics in case of storage and transportation;

To exclude 3) or as much as possible to reduce risk of infection of patients, users and other persons, and also contaminations of products.

20. Technical characteristics and functional properties of products of medical appointment shall not worsen during service life of product of the medical appointment specified by the manufacturer under the influence of external factors and subject to threat health and safety of patients, users in case of normal operation of products in the conditions corresponding to maintenance instructions of the manufacturer.

21. If products of medical appointment are intended for introduction of medicines, they shall be compatible to these medicines taking into account functional properties of products of medical appointment according to appointment, conditions of application and storage of these medicines.

22. Production of medical optics is made on the machines which are specially intended for processing of optical lenses according to the recipe which is written out to the specific patient.

23. Accuracy of the made points on the special equipment (диоптриметр) in the presence of the client, on compliance with data of the recipe is without fail performed.

Appendix 1

to Rules of production of medicines and products of medical appointment

Regulations of variations, admissible in case of production of medicines (including homeopathic) in drugstore

 

1. Variations, admissible in the mass of separate doses when packing powders, including powder dosers, are determined on the registered dose of one powder.

Variations, admissible in the lump of homeopathic trituration, are determined on the registered mass of trituration.

 

The registered weight,	% variations
1	2
To 0,1	±15
Over 0,1 to 0,3	±10
Up to 1 0,3 from above	±5
Over 1 to 10	±3
Over 10 to 100	±3
Over 100 to 250	±2
Over 250	±0,3

 

2. Variations, admissible in the lump of granules homeopathic (including when packing) for one packaging:

 

The registered weight,	% variations
1	2
To 1	±5
Over 1 to 100	±3

 

3. Variations, admissible in the mass of separate doses of suppositories and pills:

1) at least 10 suppositories or pills determine average weight weighing (to within 0,). In case of production less than 10 pieces weigh all suppositories;

2) variations in the mass of suppositories and pills from average weight determine weighing of each suppository or pill with the minimum selection 5 pieces;

Acceptable deviations from average weight shall not exceed 3):

for suppositories of ±5%;

for pills with weight to 0,3 of ± 10%;

for pills weight over 0,3 of ± 5%.

4. Variations, admissible in the mass of the registered doses of separate medicinal substances in powders, pills and suppositories (in case of production by method of rolling-out or pouring out) are determined on dose of each substance entering these medicines:

 

The registered weight,	% variations
1	2
To 0,02	±20
Over 0,02 to 0,05	±15
Over 0,05 to 0,2	±10
Over 0,2 to 0,3	±8
Over 0,3 to 0,5	±6
Up to 1 0,5 from above	±5
Over 1 to 2	±4
Over 2 to 5	±3
Over 5 to 10	±2
Over 10	±1

 

5. Variations, admissible in total amount of liquid medicines in case of production by masso-volume method, and also in subitems 7, 9 it must be kept in mind that variations are provided for liquid medicines in case of production with use both concentrates, and solids:

 

The registered amount, ml	Variations, %
1	2
To 10	±10

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