ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of October 28, 2020 No. KR DSM-165/2020

About approval of Rules of carrying out medicine of research of stability by the producer, establishments of storage duration and repeated control of medicines

According to Item 3 of article 231 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve Rules of carrying out medicine of research of stability by the producer, establishments of storage duration and repeated control of medicines.

2. Recognize invalid:

1) the 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, products of medical appointment and medical equipment" (it is registered in the Register of state registration of regulatory legal acts at No. 12133, it is published on November 10, 2015 in information system of law of Ad_let);

2) the order of the Minister of Health of the Republic of Kazakhstan of April 22, 2019 No. KR DSM-44 "About introduction of amendments to some orders of the Ministry of Health of the Republic of Kazakhstan and the Ministry of health and social development of the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts at No. 18582, it is published on May 2, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan in electronic form).

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 representation in 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.

No. KR DSM-165/2020 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of October 28, 2020

Rules of carrying out medicine of research of stability by the producer, establishments of storage duration and repeated control of medicines

Chapter 1. General provisions

1. These rules of carrying out medicine of research of stability by the producer, establishments of storage duration and repeated control of medicines (further - Rules) are developed according to Item 3 of article 231 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" and determine requirements to carrying out researches of stability, establishment of storage duration and repeated control of medicines.

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

1) validation - confirmation on the basis of submission of objective certificates of the fact that the requirements intended for specific use or application are executed;

2) medicine expiration date - date after which expiration medicine is not subject to application;

3) quality of medicine - the set of properties and characteristics of pharmaceutical substance (active pharmaceutical substance) and medicine providing their compliance to purpose;

4) considerable changes - changes of indicators of quality of medicines in case of the accelerated stability researches;

5) 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;

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

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

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

9) 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;

10) 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;

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

12) stability - capability of medicine to keep properties in the limits set by the regulating document on control of quality and safety of medicine during the storage duration (period) of repeated control under proper storage conditions;

13) the accelerated stability researches - the researches which are conducted for the purpose of assessment of the remote effects of long-term researches of medicines and influence of short-term variations from the regulated storage conditions;

14) stability researches in stress conditions (stressful researches of stability) - the testing which are carried out with research purpose of forced process of decomposition of new pharmaceutical substances and made of them, medicines;

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

16) the specification of stability - the list of requirements to which there corresponds quality of medicine till the expiry date or date of repeated control;

17) protocols - the documents reflecting course of production of each product series including realization, and also all factors concerning quality of finished goods;

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