DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 No. 81

About approval of Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 6 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 87 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 108:

1. Approve the enclosed Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation (further - Rules).

2. Inspection of compliance to Rules is carried out within pharmaceutical inspections according to the procedures established by the legislation of state members of the Eurasian Economic Union taking into account the recommendations containing in Sections VII and VIII of Rules.

Test laboratories of state members of the Eurasian Economic Union are also considered corresponding to Rules if as authorized body according to the legislation of state member of the Eurasian Economic Union compliance of these test laboratories to requirements of documents in the field of standardization, identical to the documents specified in Item 1 of Rules is recognized.

3. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Members of council of the Eurasian economic commission: From the Republic of Armenia

V. Gabriyelyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

A. Mamin

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 81

Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation

I. General provisions

1. These rules are applied for the purpose of carrying out preclinical (not clinical) trials of safety of the medicines and (or) substances containing in medicines. These rules are developed for the purpose of harmonization of the international treaties and acts constituting the right of the Eurasian Economic Union (further - the Union), in the field of drug circulation with the European Union law in this area taking into account requirements of the European Union and Organization for Economic Cooperation and Development (OECD). At the same time documents of OECD of the "Principles of Proper Laboratory Practice and Monitoring of Compliance" series were used: ENV/MC/CHEM(98)17 (OECD - the Principles of proper laboratory practice), OECD/GD(95)66 (Management according to procedures of monitoring of compliance to the principles of GLP), OECD/GD(95)67 (Management on conducting inspections of the test centers and audits of researches), OCDE/GD(95)115 (Use of the principles of GLP to the computerized systems), ENV/JM/MONO(99)20 (Quality assurance according to the principles of GLP), ENV/JM/MONO(99)23 (Use of the principles of GLP to short-term researches), ENV/JM/MONO(99)24 (Role and obligations of the head of researches according to the principles of GLP), ENV/MC/CHEM(98)16 (Role and the sponsor's obligations according to the principles of GLP), ENV/JM/MONO(2002)9 (The organization and management of the researches conducted on several research platforms), ENV/JM/MONO(2004)26 (Use of the principles of GLP to the researches in vitro), ENV/JM/MONO(2007)10 (The organization and control of archives).

2. These rules are accepted for the purpose of protection of health of the person, ensuring comparable quality of results of preclinical (not clinical) trials within the Union, elimination of technical barriers in mutual trade and are applied when carrying out preclinical (not clinical) trials of safety of the substances containing in medicines.

3. Examinees objects can be both the synthetic nature, and biogenic origin, and also to represent live organisms. Research purpose of these objects is data acquisition about their properties and (or) safety for health of the person and the environment.

4. Comparable quality of results of testing is basis for mutual recognition of state members of the Union by authorized bodies (further - state members) the obtained data that will allow to exclude the additional costs connected with repeated carrying out preclinical (not clinical) trials in each state member.

5. Preclinical (not clinical) trials and not clinical trials of safety for health of the person and the environment to which these rules are applied include the work which is carried out to laboratories and vivarium.

6. These rules are applied to preclinical (not clinical) trials of safety to health of the person and the environment which carrying out is necessary for registration of medicines.

II. Determinations

7. For the purposes of these rules concepts which mean the following are used:

"hardware" (hardware) - physical components of the computerized system, including the computer and its peripheral components;

"aseptic conditions" (aseptic conditions) - condition of working environment under which the possibility of microbic and (or) viral infection is minimized;

"audit of research" (study audit) - systematic, independent and documentary comparison of primary data and having information relation with the interim and final report for the purpose of determination of accuracy of provision of primary data to them, carrying out testing according to the plan of research and standard operational procedures, receipts of the additional information which is not specified in the report, and determinations of extent of influence of the methods applied in case of data acquisition, on reliability of these data at all parties involved in research;

"validation" (validation) - documentary confirmation of the fact that the process which is carried out within the set parameters can effectively be performed also with the reproduced results;

"validation of the computerized system" (validation of a computerized system) - documentary confirmation of high degree of guarantee of compliance of the computerized system to certain characteristics, and the data obtained by means of this computerized system - to the quality objective and reliability;

"the leading (responsible) researcher" (principal investigator) is person who in case of carrying out researches on several platforms (multicenter researches) acts on behalf of the head of research and bears responsibility for certain phases of research;

"vivarium" (vivarium) - the building or the certain room under the research organization which are intended for content of laboratory animals according to precepts of law of use of animals when carrying out preclinical (not clinical) trials. The vivarium can be provided with conditions and the equipment for carrying out experiments with the containing animals, and also to perform functions of nursery for their cultivation;

"gene transfection" (gene transfection) - introduction of alien, additional DNA (single or multiple genes) in cell owner;

"start date of research" (study initiation date) - signature date of the plan of research the head of research;

"start date of experiment" (experimental starting date) - the date of receipt of the first specific data of research;

"end date of research" (study completion date) - signature date of the final report the head of research;

"end date of experiment" (experimental completion date) - the last day of data acquisition in research;

"agreement" (contract) - the signed agreement (in writing with indication of signature date) between two or more parties containing the arrangements concerning distribution of amount of works, the rights, obligations, and if necessary regulating financial questions;

"preclinical (not clinical) trial" (preclinical study (trial)) - chemical, physical, biological, microbiological, pharmacological, toxicological and other pilot study or series of researches on studying of the researched substance (medicine) by use of scientific methods of estimates for the purpose of studying of specific action and (or) proofs of safety for health of the person;

"documentation" (documentation) - the records of any kind which are drawn up in accordance with the established procedure describing or registering the methods, the organization and (or) results of preclinical (not clinical) trial of medicine, factors influencing research and the taken measures;

"changes of the plan of research" (study plan amendment) - the deliberate amendments (changes) made to the plan of research after start date of research;

"inspector" (inspector) - person who is carrying out inspections of test laboratories and audits of preclinical (not clinical) trials of medicines on behalf of authorized body;

"inspection of test laboratory" (test facility inspection) - spot test by authorized bodies of procedures and practical actions of laboratory for assessment of conformity to the principles of proper laboratory practice. During such inspection the management structure and operational procedures of test laboratory are studied, the main technicians are interviewed, quality and accuracy of the data, received in laboratory are checked, and the report in conclusion prepares;

"the test platform" (test site) - the venue of any investigation phase;

"research on several platforms" (multi-site study) - research which phases are carried out more than on 1 platform. Researches on several platforms are conducted if it is necessary to use geographically remote, organizationally isolated or otherwise the separated test platforms. The department of the organization performing functions of the test platform can treat them if other department of the same organization performs functions of test laboratory;

In vitro studies - researches in which as test systems not multicellular complete organisms, but microorganisms, or the material isolated from complete organisms or their imitation are used. The majority of the researches in vitro are short-term researches. For such researches it is necessary to use as management of provision of appendix No. 1 to these rules to facilitate work of the head of research and department of quality assurance;

"the research organization (the test center)" (test facility) - laboratory (organization) having necessary material and technical resources and qualified personnel for carrying out preclinical (not clinical) trials of medicines in the respective area;

"the researched substance (medicine)" (test item) - substance (medicine) which is subject to research;

"source code" (source code) - the original computer program constituted in form, suitable for reading (in programming language) which needs to be transferred to machine-readable form before it can be performed by the computer;

"calibration" (calibration) - set of the transactions establishing ratio between the value of size received by the used device, and the value of this size determined by means of standard;

"cellular lines" (cell lines) - cells which underwent to genetic change to immortalization and which thereof are capable to breed during the prolonged periods of in vitro and can increase and be exposed to cryopreservation in bank of cells;

"the computerized system" (computerized system) - group of components of hardware and the related software, and also the laboratory instrument equipment connected or integrated with the computer, developed and collected for accomplishment of certain function or group of functions;

"computer safety" (computer security) - ensuring protection computer hardware and the software from accidental or intentional access, use, modification, destruction or disclosure. Such safety concerns also to personnel, these, communication bonds, physical and logical protection of computer installations;

"control of changes" (change control) - permanent assessment and documentation of system transactions and changes for the purpose of determination of need of carrying out process of validation after emergence in system of any changes. Control of changes concerns not only the computerized systems, but also other processes connected with the preclinical (not clinical) trial conducted according to these rules;

"confidentiality" (confidentiality (privacy)) - need of storage in secret information belonging to the sponsor and (or) test laboratory;

"short-term research" (short-term study) - the research conducted in short terms using standard widespread methods;

"acceptance criterions" (acceptance criteria) - documentary confirmed criteria which need to correspond for successful completion of investigation phase or fulfillment of requirements of delivery;

"critical phases" (critical phases) - certain procedures or types of activity within the research which exact and correct execution is necessary condition for quality, reliability and reliability of the received results of research;

"monitoring" (monitoring) - control procedure of compliance of the conducted preclinical (not clinical) trial and ensuring its carrying out, data collection and representation of results of research to the plan, standard operational procedures and requirements of these rules;

"proper laboratory practice (rule of laboratory practice)" (Good Laboratory Practice, GLP) - system of requirements to the organization, planning and carrying out preclinical (not clinical) trials of substances (medicines), to registration of results and quality control of the specified researches;

"not clinical trial of safety for health of the person and the environment" (non-clinical health and environmental safety study) - experience or series of experiences in which the researched substance undergoes testing in vitro or in the environment for the purpose of data acquisition about its properties and (or) the safety sent to authorized bodies;

"the carrier (solvent)" (vehicle) - the substance used for mixing, dispersion or dissolution of the researched substance (medicine) or model of comparison (control sample) and allowing to facilitate its introduction in test system;

"quality assurance" (quality assurance) - set of the systematic and systematic actions providing compliance of the conducted research to requirements of these rules;

"model of comparison (control sample)" (reference item (control item)) - the sample of substance (medicine) used for comparison with the researched substance (medicine) and assessment by scientific methods of safety of the researched substance (medicine) by such comparison of their physical, chemical, biological and pharmaceutical properties;

"samples (tests)" (specimen (supplements)) - the materials received from test test system for the purpose of studying, the analysis or preserving;

"the conventional technical standards" (recognized technical standards) - the standards accepted by the national or international bodies on standardization (state standard specification, interstate standards), the OECD Organisation of Economic Co-operation and Development standards (Organizations for Economic Cooperation and Development), ISO, International organization for standartization (International Organization for Standardization, ISO), IEEE, Institute of Electrical and Electronics Engineers (Institute of Electrical and Electronics Engineers), etc.);

"monitoring body of observance of these rules" (GLP monitoring authority) - the body of state member authorized on monitoring procedure of observance by test laboratories in the territory of state member of these rules in case of accomplishment of preclinical (not clinical) trials of medicines;

"the main schedule" (master schedule) - the working schedule of the generalizing level reflecting the current information on stage and condition of all researches in the test center;

"variation from the plan of research" (study plan deviation) - inadvertent departure from the plan of research after start date of research;

"patent material" (proprietary material) - the material protected by the legislation of state member (about patents, copyright or trademarks) from illegal use;

"primary data" (raw data) - initial records and documentation (their verified copies) which are result of initial observations and activities in the course of the research. Primary data can also include, for example, photos, microfilms or microfiches, machine-readable carriers, the dictated observations, the written-down data from the automated equipment or any other means of storage of information capable to provide reliable storage of information during the period of time specified in the Section VI of these rules;

"primitive cells" (primary cells) - the cells isolated from organism of animal or vegetable source and having limited life expectancy;

"cross pollution" (cross-contamination) - pollution of the researched substance or test system other researched substance or other test system which occurs inadvertently and in case of which degree of chemical purity of the researched substance is broken or is damaged test system;

"peripheral components" (peripheral components) - any equipment connected with the help of the interface or auxiliary or remote components, including printers, modems, terminals, etc.;

"the plan (the protocol, the program) of research" (study plan) (further - the plan) - the document containing the main objectives, methodology, procedures, statistical aspects, the organization and resource planning of preclinical (not clinical) trial (including its stages and parts), and also measures for safety of the systems participating in it;

"checking of measuring instrument" (verification of instrumentation) - set of the transactions which are carried out by the public metrological service or other accredited legal entities for the purpose of determination and confirmation of conformity of measuring instrument to the established metrological requirements;

"supplier" (supplier) - the legal entity who is fulfilling obligation within contracts with test laboratory on equipment, reactants, consumable materials, test systems of preclinical (not clinical) trials;

"acceptance test" (acceptance testing) - the testing of the computerized system executed in the established form in expected working environment for the purpose of determination of compliance of this system to acceptance criterions of test laboratory, and also the system acceptability for operation;

"the software - operating system" (software - operating system) - the program or set of the programs, standard (routine) programs and subprogrammes controlling operation of the computer. The operating system can provide such services as resource allocation, work planning, management of input (conclusion) and data management;

"the software - appendix" (software - application) - the program acquired or developed, adapted or adapted for requirements of test laboratory for the purpose of control of processes, collection, processing, representation and (or) archiving of data;

"backup" (back-up) - the measure undertaken for recovery of files of data and the software, renewal of data processing or use of the alternative computer equipment after system failure or accident;

"the summary (autobiography)" (curriculum vitae) - the document confirming education, professional training and experience;

"the head of research" (study director) is person responsible for general carrying out preclinical (not clinical) trial of safety for health of the person and the environment;

"management of the test site" (test site management) - persons designated responsible for control of investigation phases and carrying out research according to these rules;

"the management of the research organization (the test center)" (test facility management) is the persons having powers and bearing responsibility for the organization and functioning of test laboratory according to these rules;

"series" (batch) - certain quantity or batch of the researched substance made during predefined production cycle in such form when uniformity of content of all quantity (batch) of substance is supposed or this content shall be characterized as such;

"system of quality assurance" (quality assurance programme) - the package of measures, the these rules directed to observance by personnel intended for ensuring management of test laboratory according to these rules;

"the specification on the researched substance (medicine)" (specification on test item) - the document containing information on the researched substance (medicine);

"the specification on test systems" (specification on test-system) - the document establishing requirements to test systems;

"the sponsor (developer of medicine)" (sponsor) - physical person or legal entity which initiates provides and (or) approves carrying out preclinical (not clinical) trial of safety for health of the person and ecological safety, draws up the order and bears responsibility for the organization and financing of such research;

"standard operational procedures (SOP)" (standard operating procedures (SOPs) - documentary drawn up procedures in which the method of carrying out research or implementation of activities which is not stated in detail in the plan (the protocol, the program) or instructions for carrying out researches is described;

"test system" (test system) - the biological, chemical, physical system used in research, the analytical equipment or their combination;

"toksikogenomika" (toxicogenomics) - research of reaction of genome to stress factors of the environment or toxic substances for the purpose of determination of ratio between toxic reactions to toxic substances and changes in genetic profiles of the objects which were affected by these toxic substances;

"toksikometabonomika" (toxicometabonomics) - quantitative measurement of time-dependent multiple parameter metabolic reaction of live systems to pathophysiological incentives or genetic modification by systematic studying of composition of bioliquid with use of technology of the nuclear magnetic resonance (NMR) of recognition of set, for determination of communication of toxicity of target organ with the nuclear magnetic resonances spectral sets and determination of new substitute markers of toxicity;

"toxicity" (toxicity) - measure of harmful effects of the researched material on organism in the conditions of single or repeated introduction;

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