of April 17, 2015 No. 49
About approval of the Instruction about procedure and conditions of quality control of the medicines made in drugstores
Based on parts four and the seventh article 10 of the Law of the Republic of Belarus of July 20, 2006 "About medicines" and subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" the Ministry of Health of the Republic of Belarus DECIDES:
1. Approve the Instruction about procedure and conditions of quality control of the medicines made in drugstores it (is applied).
2. Declare invalid the resolution of the Ministry of Health of the Republic of Belarus of August 14, 2000 No. 35 "About quality control of the medicines produced in drugstores" (The national register of legal acts of the Republic of Belarus, 2000, No. 89, 8/3970).
3. This resolution becomes effective after its official publication.
First Deputy Minister
D.L.Pinevich
Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 No. 49
1. This Instruction establishes procedure and conditions of quality control of the medicines made in drugstores (further - quality control).
2. Action of this Instruction extends on legal entities of the Republic of Belarus, the individual entrepreneurs registered in the Republic of Belarus, the foreign legal entities and the foreign organizations created according to the legislation of foreign states in the presence of the representation opened in accordance with the established procedure in the territory of the Republic of Belarus, the medicines performing pharmaceutical production and quality control (further if other is not determined, - legal entities and individual entrepreneurs).
3. For the purposes of this Instruction the main terms and their determinations in the values established by the Law of the Republic of Belarus of June 18, 1993 No. 2435-XII "About health care" and the Law of the Republic of Belarus "About drug circulation are used".
4. The medicines made in drugstores according to recipes of doctors (further - the recipe) or (and) to requirements (requests) of the organizations of health care are exposed to quality control (further - the requirement).
5. For monitoring procedure of quality the methods and reactants specified in the State pharmacopeia of the Republic of Belarus are used.
6. Quality control is carried out daily by specialists pharmacists of drugstores (further – the specialist pharmacist) according to their job responsibilities, and also the test laboratories included in the list of the test laboratories exercising quality control of the medicines made in the drugstores accredited in the National accreditation system of the Republic of Belarus for testing of medicines according to appendix 1 (further – test laboratories) in the cases provided by this Instruction.
7. In case of monitoring procedure of quality its following types are applied: written, organoleptic, physical, chemical, microbiological.
8. Test laboratories quarterly carry out chemical and microbiological quality control.
At the same time test laboratories perform selection from drugstores of samples of medicines with creation of the sampling report of the medicines made in drugstore, in form according to appendix 2, drawn up in duplicate.
9. Results of the quality control which is carried out by test laboratories are drawn up by the test report of the medicine made in drugstore in form according to appendix 3, which after the end of testing goes to three-day time to the legal entity or the individual entrepreneur, and in case of medicine recognition low-quality – in public institution "The state pharmaceutical supervision in the sphere of drug circulation Gosfarmnadzor (further – GU "Gosfarmnadzor").
Results of the quality control which is carried out in drugstores are registered in accounting documents (magazines) in forms according to appendices 4-6, which are stored in drugstores at least one year.
10. The medicine made in drugstore, which is not conforming to requirements of the State pharmacopeia of the Republic of Belarus is recognized low-quality and is liable to destruction in the procedure established by the legislation.
11. In case of need carrying out additional technological transactions for the purpose of reduction of composition of medicine repeated quality control according to the procedure, established by this Instruction is carried out to compliance with the recipe or the requirement.
12. Written quality control consists in written execution of data on the medicine made in drugstore when filling the passport of written quality control of the medicines made in drugstore in form according to appendix 6 (further - the passport of written control) and check of compliance of entries in the passport of written control to the recipe or the requirement.
All medicines made in drugstores are exposed to written quality control.
13. The passport of written control is filled in with the pharmaceutical worker of drugstore who made medicine, directly after the end of its production according to the sequence of technological transactions.
14. In passports of written control of homeopathic medicines in case of use in case of their production of semifinished products, trituration, cultivations concentration and quantity (amount or weight) of semifinished products, trituration or cultivations, and also necessary mathematical formulas and calculations, coefficients are specified.
In passports of written control of medicines depending on dosage forms in addition it is specified for:
powders, suppositories, pills - the lump, quantity and mass of separate doses;
thaw eye, solutions for injections and infusions - the name and amount of the isotinting and stabilizing excipients.
Passports of written control remain in drugstore at least three months.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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