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

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" PRIKAZYVAYU:

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

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

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

2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan;

4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of health and social development of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), and 3) of this Item.

3. To impose control of execution of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

4. This order becomes effective after day of its first official publication.

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of May 28, 2015 No. 405

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.

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 drugstore according to appendix 1 to these rules, and also regulatory legal acts of the Republic of Kazakhstan in the sphere of drug circulation, products of medical appointment and medical equipment, reference books.

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, certified by the signature of the head of drugstore and drugstores are sealed (in the presence).

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 66-1 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" in compliance.

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;

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