of April 17, 2015 No. 51
About procedure and conditions of conducting inspection (pharmaceutical inspection) of pharmaceutical production of the revealed low-quality medicine
Based on part eight of article 12 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation", the paragraph of the eighth subitem 8.17 of Item 8, of 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, the Ministry of Health of the Republic of Belarus DECIDES:
2. 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. 51
1. This Instruction determines procedure and conditions of conducting inspection (pharmaceutical inspection) of pharmaceutical production of the revealed low-quality medicine regarding compliance to requirements of Proper pharmaceutical practice and pharmacopoeian Articles of the State pharmacopeia of the Republic of Belarus (further, unless otherwise specified, – inspection) and extends on legal entities and the individual entrepreneurs performing pharmaceutical activities regarding pharmaceutical production of medicines.
2. For the purposes of this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus "About drug circulation" are used.
3. Conducting inspection is performed in the following cases:
the medicine made in drugstore according to the recipe of the doctor, acknowledged test laboratory accredited in the National accreditation system of the Republic of Belarus for testing of medicines (further – test laboratory), low-quality can also pose itself hazard to life and (or) health of the person;
the medicine made in drugstore according to requirements (requests) of the organizations of health care or medicine in the form of intra pharmaceutical procurement and packing either the waters purified or the water for injections made in drugstore which are medicines are acknowledged as test laboratory low-quality.
4. The decision on conducting inspection is made by public institution "The state pharmaceutical supervision in the field of drug circulation Gosfarmnadzor (further – GU "Gosfarmnadzor") based on the test report of the medicine received from test laboratory, in time, not exceeding 5 working days from the moment of its obtaining, and drawn up by the order.
The order on conducting inspection shall contain:
purpose of conducting inspection;
basis for conducting inspection;
the name and the address of drugstore in which low-quality medicine was revealed;
full name of the legal entity (surname, own name, middle name (if that is available) the individual entrepreneur who possesses drugstore on the property right or other legal cause (further – the legal entity or the individual entrepreneur), its location (the residence of the individual entrepreneur);
structure of inspection team;
period of conducting inspection.
5. Conducting inspection is performed by inspection team of GU "Gosfarmnadzor" headed by the leading inspector.
The leading inspector constitutes the program of inspection for form according to appendix 1 and sends to her legal entity or the individual entrepreneur no later than 3 working days prior to inspection.
6. Inspection is carried out according to the program of inspection which accomplishment is provided by the leading inspector, and includes:
visit of drugstore in which low-quality medicine is revealed;
carrying out before inspection of introductory meeting on which the leading inspector represents members of inspection team, discloses the purposes and area of inspection, specifies the program of inspection and the schedule of its carrying out, declares nondisclosure of information obtained during inspection and answers questions of representatives of drugstore;
survey of the rooms and the equipment relating to pharmaceutical production of medicine;
studying of documents of the quality system (standard operational procedures, technological instructions, records, reports, test reports);
receipt of copies of documents, written and oral explanations from representatives of drugstore;
observation of activities of workers of drugstore on workplaces, poll of workers of drugstore;
sampling of the medicines made in drugstore for monitoring procedure of their quality (if necessary);
acquaintance of responsible persons of drugstore with preliminary results of inspection at the end of each working day of inspection, and also at final meeting after its completion, discussion of preliminary observations with representatives of drugstore;
creation of the report on inspection and its direction to the legal entity or individual entrepreneur;
assessment of the plan of the adjusting and warning actions, the report on its accomplishment and the documents testimonial of elimination of the revealed discrepancies or on the taken measures directed to elimination of such discrepancies.
7. Within conducting inspection members of inspection team:
have access to rooms of drugstore in case of presentation of the official ID and decision on conducting inspection;
use with the consent of the representative of drugstore technical means, including the equipment performing zvuko-, video, photographing (if necessary).
8. Sampling of the medicines made in drugstore is performed according to requirements of the State pharmacopeia of the Republic of Belarus in cases:
establishments when conducting inspection of violations of temperature condition and humidity in case of storage of medicines in the rooms intended for their storage, including calling into question quality of the medicine made in drugstore;
emergence of reasonable doubts in authenticity of the documents specified to reliability in them the data.
Sealed packaging with the selected samples of the medicine made in drugstore, and the sampling report go the leading inspector or the representative of drugstore to test laboratory.
9. During inspection can be revealed:
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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