ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of October 17, 2012 No. 812

About approval of Rules of production (production) and quality control of medicines in drugstores

According to article 4 of the Law of Ukraine "About medicines", subitem 8.9 of the subitem 8 of item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467, and also for the purpose of strengthening of control of quality of medicines which are made (are produced) in drugstores, I ORDER:

1. Approve Rules of production (production) and quality control of medicines in drugstores (further - Rules) which are applied.

2. To provide to public service on medicines and control of drugs and its territorial authorities control over the implementation of requirements of the order by subjects of managing irrespective of subordination and pattern of ownership.

3. Declare invalid the order of the Ministry of Health of Ukraine of December 15, 2004 No. 626 "About approval of Rules of production (production) of medicines in the conditions of drugstore", registered in the Ministry of Justice of Ukraine on December 20, 2004 for No. 1606/10205.

4. In accordance with the established procedure to provide to the head of department of medicines and medical products submission of the order on state registration in the Ministry of Justice of Ukraine.

5. To impose control over the implementation of the order on the deputy minister - the chief of staff of Bogachyov R. M.

6. This order becomes effective from the date of its official publication.

Approved by the Order of the Ministry of Health of Ukraine of October 17, 2012 No. 812

Rules of production (production) and quality control of medicines in drugstores

І. General provisions

1.1. These Rules are developed according to article 4 of the Law of Ukraine "About medicines", and also for the purpose of strengthening of control of quality of medicines which are made (are produced) by subitem 8.9 of the subitem 8 of item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467, in drugstores.

1.2. Action of these Rules extends to all subjects of managing who perform production (production) of medicines in the conditions of drugstores.

1.3. The main terms which are used in these Rules:

active pharmaceutical ingredient (medicinal substance, active ingredient, substance) (further - AFI or active ingredient) - any substance or mix of substances which is held for use in production of medicine and during this use becomes its active ingredient. Such substances have pharmacological or other direct action on human body; as a part of ready forms of medicines they are applied to treatment, diagnostics or prevention of disease, to change of condition, structures or physiologic functions of organism, to leaving, processing and relief of symptoms;

the aseptic block - complex of production rooms which part are lock, aseptic assistant, the room for receipt of water for injections, packing, blockage and sterilization of the produced (made) medicines;

assistant - the certain, respectively equipped production room in drugstore for production (production) of medicines;

production (production) of medicines in the conditions of drugstore - personal industry (production) of medicines according to recipes of doctors, by request (requirement) of treatment-and-prophylactic institutions and production (production) of intra pharmaceutical procurement;

production rooms - rooms in drugstores in which are made (are produced), controlled, packed, medicines are marked, stored and provided. Placement of production rooms of drugstores which perform production (production) of medicines shall exclude counter production flows;

intra pharmaceutical procurement - the concentrated solutions and semifinished products which use for production (production) of ex-temporal medicines, and the ex-temporal medicines produced (made) for the future on often repeated copy-books;

intra pharmaceutical control - package of measures of precaution and types of control which approve indicators of quality and safety of medicines which is performed directly in drugstore;

The state pharmacopeia of Ukraine is legal act which contains general requirements to medicines, pharmacopoeian Articles, and also techniques of quality control of medicines (further - GFU);

source of radionuclides - any system which contains the fixed primary radionuclide of which secondary radionuclides which are extended by eluating or in a different way are formed and are used in radio pharmaceutical medicine;

active ingredients (substances) - biologically active agents which can change condition and functions of organism or have preventive, diagnostic or medical action and are used for production (production) of finished pharmaceutical products;

excipients - the additional substances necessary for production (production) of finished pharmaceutical products;

ex-temporal medicines (further - ELS) the medicines made (made) in pharmaceutical conditions on the recipe of the doctor for the specific patient or by request (requirement) of treatment-and-prophylactic institution and intra pharmaceutical procurements. Also the medicines produced (made) for the future on often repeated copy-books belong to ex-temporal medicines;

contamination - undesirable introduction of impurity of the chemical or microbiological nature or foreign substances in (on) initial raw materials, intermediate products, finished goods or AFI during engineering procedure, sampling, packaging or repacking, storage and transportation;

the concentrated solutions (concentrates) are outgoing solutions of medicinal substances in much bigger concentration, than these substances state in recipes, counting on the corresponding cultivation to the concentration specified in the recipe (further - concentrates);

dosage form - condition, provided medicine convenient to the use, in case of which the necessary medical effect is provided;

medicine - any substance or combination of substances (one or several AFI and excipients) which has properties and is intended for treatment or prevention of diseases at people, either any substance or combination of substances (one or several AFI and excipients) which can be intended for the prevention of pregnancy, recovery, correction or change of physiologic functions at the person by implementation of pharmacological, immunological or metabolic action or for establishment of the medical diagnosis;

medicine - medicine in the form of certain dosage form. It is the ready-made product which is packed up, packed, marked which has certain medical purpose and fixed term of suitability;

the medicines produced (made) for the future, the ex-temporal medicines produced (made) in advance which keep ready for the future before issue according to the recipe or the order;

methods of quality control (further - MKK) - the regulating documentation approved in accordance with the established procedure which determines techniques of quality control of medicines establishes qualitative and quantitative indices of medicine and their admissible limits, requirements to packaging, marking, storage conditions, transportations, to the suitability term which were approved in case of state registration (re-registration) of medicine;

semifinished products - intra pharmaceutical procurements of mixes of two or more substances in those ratios, as in copy-books which are most often made (are produced) in drugstores;

radionuclide precursor - any other radionuclide intended for introduction of radioactive tag in other substance before its application;

radioactive medicines - medicines which are applied in medical practice thanks to their property to ionizing radiation;

radionuclide set - any medicine which shall be connected or mixed with radionuclides in ready radio pharmaceutical medicine, as a rule, before its application;

radio pharmaceutical medicine - any medicine which contains in condition, ready for application, one or more radionuclides (radioactive isotopes) entered into it with the medical purpose;

medicine series - certain quantity of homogeneous products (medicine) made (made) in drugstore from certain amount of raw materials according to the technological instruction in single engineering procedure from one loading in unit of the capacity equipment. Sign of series is uniformity;

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