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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 20, 2020 No. KR DSM-287/2020

About approval of rules of carrying out intra pharmaceutical control of the made medicines

According to article 232 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve the enclosed rules of carrying out intra pharmaceutical control of the made medicines.

2. Recognize invalid:

1) the order of the Minister of health and social development of the Republic of Kazakhstan of May 28, 2015 No. 405 "About approval of Rules of carrying out intra pharmaceutical control of the made medicines" (it is registered in the Register of state registration of regulatory legal acts at No. 11480, it is published on July 23, 2015 in information system of law of Ad_let);

2) the order of the Minister of Health of the Republic of Kazakhstan of February 7, 2017 No. 10 "About modification and amendments in the order of the Minister of health and social development of the Republic of Kazakhstan of May 28, 2015 No. 405 "About approval of Rules of carrying out intra pharmaceutical control of the made medicines" (it is registered in the Register of state registration of regulatory legal acts at No. 14879, it is published on April 24, 2017 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan).

3. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

5. This order becomes effective after ten calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Tsoi

No. KR DSM-287/2020 are approved by the Order Minister of Health of the Republic of Kazakhstan of December 20, 2020

Rules of carrying out intra pharmaceutical control of the made medicines

Chapter 1. General provisions

1. These rules of carrying out intra pharmaceutical control of the made medicines (further – Rules) determine procedure for carrying out intra pharmaceutical control of the made medicines.

2. The head of drugstore appoints the pharmacist-analyst responsible for the organization and monitoring procedure of quality of the produced medicines in drugstore.

3. The head of drugstore provides workplace of the pharmacist-analyst with the standard set of measuring instruments, the test equipment, laboratory glassware, auxiliary materials applied when carrying out analytical works in drugstores according to the list of standard sets of measuring instruments, the test equipment, laboratory glassware, the auxiliary materials applied when carrying out analytical works in drugstores according to appendix 1 to these rules, and also regulatory legal acts of the Republic of Kazakhstan in the sphere of drug circulation and medical products.

4. The medicines made in drugstore including intra pharmaceutical procurement, the packed-up products, concentrates and semifinished products are exposed to intra pharmaceutical control.

5. Intra pharmaceutical control is carried out by carrying out:

1) preventive (precautionary) actions;

2) acceptance review of the initial materials (medicinal substance, excipient) used for production of medicines;

3) written control;

4) selective polling control;

5) organoleptic control;

6) selective physical control;

7) chemical control;

8) control in case of leave.

6. Results of organoleptic, selective physical control, chemical control of medicines are registered in the Magazine of registration of results of organoleptic, selective physical control, chemical control of intra pharmaceutical procurement, the medicines made according to recipes (requirements of the medical organizations), concentrates, semifinished products, trituration, alcohol ethyl and packing in form according to appendix 2 to these rules. Pages of the Magazine are numbered, stitched and certified by the signature of the head of drugstore.

7. Quality control of the medicine made in drugstore is carried out on compliance to indicators, methods and techniques according to Item 1 of article 240 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further – the Code).

Chapter 2. The preventive (precautionary) actions directed to decrease in risk of emergence of mistakes and to quality assurance of the produced medicines

8. Preventive (precautionary) actions consist:

1) in observance of conditions of aseptic production of medicines;

2) in ensuring serviceability and accuracy of weight measuring devices, carrying out their annual checking;

3) in observance of conditions for obtaining, collection, storage of the water purified waters for injections, correctness of marking of reservoir in the form of specifying on label of the date of receipt, number of the analysis and signature of person making the analysis;

4) in adherence to deadlines, storage conditions of reactants, reference and titrovanny solutions and their correct registration (on labels except the name concentration, molyarnost, the date of receipt, end date of expiration date, the storage condition by whom it is made are specified);

5) in determination of variations in the checked medicines use of measuring means of the same type (with identical metrological characteristics), as in case of their production in drugstores;

6) in processing, filling, registration of byuretochny installation and shtanglas.

9. Shtanglasa (pharmaceutical container) draw up as follows:

1) on shtanglasa with medicinal substances and excipients which contain in rooms of storage also the manufacturing plant, number of series of the manufacturing plant, number and effective period of the certificate of conformity of products, expiration date of medicinal substance, date of filling, the signature of the medicinal substance which filled shtanglas and verified authenticity specify the name, the country;

2) on shtanglasa with medicinal substances and excipients which contain in the assistant room fillings of the shtanglas, the signature which filled shtanglas and verified authenticity of medicinal substance and excipient specify date;

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