ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of August 25, 2015 No. 680

About approval of Rules of production and quality control, and also carrying out testing of stability and establishment of storage duration and repeated control of medicines and medical products

According to Item 3 of article 67 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 production and quality control, and also carrying out testing of stability and establishment of storage duration and repeated control of medicines and medical products.

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 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.B.

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 August 25, 2015 No. 680

Rules of production and quality control, and also carrying out testing of stability and establishment of storage duration and repeated control of medicines and medical products

Chapter 1. General provisions

1. These rules of production and quality control, and also carrying out testing of stability and establishment of storage duration and repeated control of medicines and medical products (further - Rules) are developed according to Item 3 of article 67 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" and determine procedure for production and quality control, and also carrying out testing of stability and establishment of storage duration and repeated control of medicines and medical products.

2. In these rules the following basic concepts are used:

1) cross contamination - pollution of substance, materials or products other substances, materials or products;

2) intermediate products - partially processed raw materials which shall pass further stages of production process before it becomes ready-made product;

3) initial materials - any substance (raw materials, intermediate product or medicinal substance), except packaging materials, used for production of medicines and medical products;

4) finished goods - the pharmaceutical products which passed all stages of engineering procedure including final packaging;

5) quality of medicine and medical product - set of the properties and characteristics of medicine and medical product influencing their capability to be effective to destination;

6) the manufacturing organization of medicine - the legal entity performing production;

7) production of medicines and medical products - the pharmaceutical activities including set of all works necessary for serial release of the medicines and medical products connected with acquisition of raw materials, materials and semifinished products, engineering procedure, including with implementation of one of its stages, storage, realization of the made products, and also all types of the control accompanying them;

8) considerable changes - changes of indicators of quality of medicines in case of the accelerated stability testing;

9) semi-product - products which passed one or several stages of processing and are used further for receipt of finished goods;

10) expiration date - date after which expiration medicine and medical product is not subject to application;

11) quarantine - the status of initial or packaging materials, the intermediate, bulk or ready-made products isolated physically or otherwise before decision about their release in realization, rejection or conversion;

12) contamination - undesirable entering of impurity of chemical or microbiological origin or foreign material into initial material, intermediate product or medicinal substance in course of production, sampling, packaging or repacking, storage or transportation;

13) calibration - set of the transactions establishing ratio between the value of size received by means of this gage and the corresponding value of size determined by means of standard for the purpose of determination of the valid values of metrological characteristics of measuring instrument and (or) suitability to use of the measuring instrument which is not subject to the state metrological supervision;

14) climatic zone - zone with prevalence of certain climatic conditions within year;

15) packaging material - the material intended for production of container, packaging and supportive packaging applications. Packaging materials subdivide on primary or secondary depending on whether there are they in direct contact with medicine or not;

16) the period of repeated control - period of time before date of the following control during which steady medicinal substance under proper storage conditions conforms to requirements of the normative and technical document for control of quality and safety of medicine;

17) the application period - period of time during which the medicine prepared by dissolution or which is in multidose container after the first opening can be used by the patient;

18) average kinetic temperature - the settlement annual average temperature of storage of medicine influencing kinetics of its decomposition in case of this ratio of temperature and time of testing;

19) control in production process (production supervision) - the check performed during engineering procedure for the purpose of control and in need of process regulation to provide products compliance to specifications;

20) checking of measuring instruments - set of the transactions which are carried out by the public metrological service or other accredited legal entities for the purpose of determination and confirmation of conformity of measuring instrument to the established technical and metrological requirements;

21) the production instruction - the internal document of the producer regulating certain part of production process;

22) production sanitation - system of the organizational actions and technical means preventing or reducing impact of dangerous production factors on working;

23) production rooms - the rooms located in specially intended buildings where production process, quality control is exercised;

24) production schedules of production - the regulating document establishing production methods, technological standard rates, technical means, conditions and procedure for carrying out engineering procedures in production of medicines and medical products;

25) sampling - actions for withdrawal of samples (tests) of raw materials, intermediate and finished goods for determination of their quality;

26) control service of quality - structural unit (department, test laboratory) of the producer which bears responsibility for quality assurance and control of quality;

27) storage duration - period of time during which medicine and medical product under proper storage conditions conforms to requirements to regulating documents on control of quality and safety of medicine and medical products;

28) standard working operational technique - the approved written technique stating instructions for implementation of works, not necessarily specific to this medicine or substance, and having general nature on accomplishment of separate transaction types: on cleaning, disguise, control of the environment, sampling, carrying out testing, operation of the equipment;

29) corrective actions - actions taken for elimination of the existing discrepancies, defects or the undesirable situation influencing engineering procedure;

30) technological instructions - type of production instructions which contain data on procedure for conducting engineering procedure;

31) specifications - the regulating document on standardization establishing technical requirements, including acceptance procedures and control methods, to specific type, brand, model, type of the made and implementable medical products, approved as the producer;

32) engineering procedure - the transactions connected with production of medicines and medical products, including, receipt of raw materials, processing, packaging and receipt of finished goods;

33) testing of stability in real time (long-term testing of stability) - the testing which are carried out for the purpose of establishment of storage duration, confirmation of probation of storage and development of recommendations under the terms of medicine storage;

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