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ORDER OF THE MINISTER OF AGRICULTURE OF THE REPUBLIC OF KAZAKHSTAN

of September 23, 2015 No. 7-1/848

About approval of veterinary (veterinary and sanitary) requirements to the organizations for production, storage and realization of veterinary medicines, forages and feed additives

(as amended on 24-01-2019)

According to subitem 46-3) of article 8 of the Law of the Republic of Kazakhstan of July 10, 2002 "About veterinary science", PRIKAZYVAYU:

1. Approve the enclosed veterinary (veterinary and sanitary) requirements to the organizations for production, storage and realization of veterinary medicines, forages and feed additives.

2. To provide to department of veterinary and food safety of the Ministry of Agriculture of the Republic of Kazakhstan in the procedure established by the legislation:

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

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

3) placement of this order on Internet resource of the Ministry of Agriculture of the Republic of Kazakhstan and the intranet portal of state bodies.

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

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

Minister of Agriculture of the Republic of Kazakhstan

A. Mamytbekov

It is approved

Minister of investments and development of the Republic of Kazakhstan

September 30, 2015

 

___________________ A. Isekeshev

It is approved

Minister of national economy of the Republic of Kazakhstan

September 28, 2015

 

___________________ E.Dosayev

It is approved

Minister of Internal Affairs of the Republic of Kazakhstan

May 24, 2015

 

___________________ K. Kasymov

Approved by the Order of the Minister of Agriculture of the Republic of Kazakhstan of September 23, 2015 No. 7-1/848

Veterinary (veterinary and sanitary) requirements to the organizations for production, storage and realization of veterinary medicines, forages and feed additives

Chapter 1. General provisions

1. These veterinary (veterinary and sanitary) requirements to the organizations for production, storage and realization of veterinary medicines, forages and feed additives (further – requirements) are developed according to subitem 46-3) of article 8 of the Law of the Republic of Kazakhstan of July 10, 2002 "About veterinary science" (further – the Law) and determine veterinary (veterinary and sanitary) requirements to the organizations for production, storage and realization of veterinary medicines, forages and feed additives.

2. Veterinary health requirements extend on the physical persons and legal entity which are engaged in production, storage and realization of veterinary medicines, forages and feed additives in the territory of the Republic of Kazakhstan.

3. In veterinary (veterinary and sanitary) requirements the following concepts are used:

1) autoclave – the special room equipped with autoclaves, consisting of the isolated departments for sterilization of laboratory glassware, substrates, tools and disinfecting (neutralization) of microorganisms infected material and other biological waste;

2) air lock – the limited space with two and more doors located between two or more rooms, for example, with different classes of purity, intended for control of flow of air between rooms in case of entrance to them is also used for movement of people and materials;

3) control (reference) strains (further – control strains) – the museum examples of the weakened (attenuirovanny) and virulent cultures of production strains of microorganism used with anti-serum to them in the help purposes for identification of again received strains isolates;

4) validation – documentary confirmation of conformity of the equipment, conditions of production, engineering procedure, quality of semi-product and finished goods to existing regulations and/or requirements of the specifications and technical documentation;

5) the organizations for production and realization of veterinary medicines – activities of the physical persons and legal entities performing production (further – the producer) and realization of veterinary medicines, in the special production rooms meeting these veterinary (veterinary and sanitary) requirements;

6) production of veterinary medicine – the organized engineering procedure including complete cycle of production (synthesis, biosynthesis, extraction, cleaning, processing, production, packing, packaging, marking, labeling) or separate stages of use of substances for receipt of ready veterinary medicine;

7) series (batch) of veterinary medicines – the certain amount of veterinary medicine received and which is packed up for one production cycle under permanent conditions, got the number of series, number of production supervision and drawn up by one document, the established form;

8) vivarium – the isolated room intended for content of experimental laboratory animals;

9) the specification – the specifications and technical documentation which is in detail describing the list of testing, references to analytical techniques and the corresponding eligibility criterions establishing numerical borders, the ranges or criteria to which there shall correspond products used or received in production process, raw materials and materials;

10) the insulator – the isolated room intended for content of the infected experimental laboratory animals;

11) contamination – in biology process of pollution as a result of contact, mixing, pollution of one substrate or biological material by another;

12) microorganisms – bacteria, viruses, rickettsiae, mycoplasmas, shiver, actinomycetes, mold fungi, seaweed and other protozoa;

13) matriksny series (batches) of control (reference) and production (vaccinal) strains of microorganisms – initial series (batches) of strains of cultures of the weakened (attenuirovanny) and virulent microorganisms received in identical conditions and used as an example for production and control of certain type of veterinary medicines;

14) intra production supervision (technology, interoperational), the checks which are carried out in course of production for the purpose of control and, in case of need, adjustments of parameters of engineering procedure in order that products conformed to requirements of the specification. Control of state of environment or the equipment is also considered as element of interoperational control;

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