National standard. With changes and additions from the National standard of the Russian Federation gost

National (state) standard- standard adopted by the standardization body of a member state of the Eurasian Economic Union: p. 2. In a broader sense: a standard adopted by the national standardization body of any state and available to a wide range of users. In Russia, the standard adopted by the national (competent) body (organization) for standardization of another state is called the "foreign state standard".

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Standardization bodies

USA

The standard is recognized as national after approval. If the accepted standard has not been approved by ANSI, it is an industry standard with a narrower application. Such standards are also referred to in practice as "de facto standards". A voluntary standard (both national and non-national) can become a mandatory standard if decided by a designated authority either at the federal or state level. The status of a mandatory standard acquires from the moment of its publication in the Federal Register (Federal Register).

Russia

In Russia, national standards have voluntary application: Art. four . except for the application of standards for defense products and for the protection of information constituting a state secret or other information of limited access: Art. 6. It is also mandatory to apply standardization documents included in the list of standardization documents specified by the Government of the Russian Federation, the mandatory use of which ensures road safety when it is organized on the territory of the Russian Federation. The obligatory application of standardization documents is established only by the law "On Standardization in the Russian Federation": Art. 2, while the use of standardization documents for the purposes of technical regulation is established in accordance with the Law "On Technical Regulation": Art. 5 .

Standardization documents:

The developer of documents of the national standardization system, with the exception of national fundamental standards and standardization rules, can be any legal or natural person or public association: Art. 23.

Documents on the standardization of defense products: p. 6:

• interstate military standards;
• state military standards;
• industry military standards;
• interstate standards with military additions to them;
• national standards with military additions to them;
• industry standards with military additions to them;
• state military standards with additions to them for the period of martial law;
• national standards with additions to them for the period of martial law;
• branch military standards with additions to them for the period of martial law;
• industry standards with additions to them for the period of martial law;
• state military standards of martial law;
• state standards of martial law;
• industry military martial law standards;
• martial law industry standards;
• interstate and national standards with uniform requirements for defense and national economic products;
• industry standards with uniform requirements for defense and national economic products;
• interstate standards, national standards, industry standards and information and technical reference books;
• organization standards, as well as technical specifications (as a type of organization standard);
• standardization rules and recommendations for the standardization of defense products;
• classifier of standards for defense products;
• all-Russian classifiers of technical, economic and social information;
• a unified codifier of supplies for federal state needs;
• regulatory and technical documents of the system of general technical requirements for types of weapons and military equipment;
• fundamental state military standards.

With regard to standardization objects created and (or) supplied outside the state defense order, standardization documents containing information constituting a state secret and (or) related to other restricted access information protected in accordance with the legislation of the Russian Federation may be approved. Such documents are approved by the federal executive body in the field of standardization and are called "national standard of limited distribution".

Story

Republican standards for products (RST RSFSR) were approved by the State Planning Committee of the RSFSR according to the product range. For the most part, the nomenclature included household items and food. Republican product standards were mandatory for ministries and departments of the RSFSR and all enterprises, organizations and institutions located on the territory of the RSFSR, regardless of their departmental subordination.

In 1990, it was established that the state standards of the USSR and the republican standards contain mandatory and recommended requirements. Mandatory requirements include product quality requirements that ensure its safety for the life and health of the population, environmental protection, product compatibility and interchangeability.

Since 1992, the state standard of the Russian Federation has been designated GOST R.

In 1997, it was established that the state standards of the Russian Federation, in terms of the mandatory requirements established in them, refer to technical regulations.

The law “On standardization” adopted in 1993 established the name “state standard of the Russian Federation”. In 2003, when the law "On Standardization" was repealed and the law "On Technical Regulation" was adopted, the name "national standard" was established. In 2015-2016, the law "On standardization in the Russian Federation" was adopted and the scope of technical regulation and standardization was delimited. Currently, the term "national standard of the Russian Federation" is used.

In 2003, there was a transition from the state standardization system to the national one. State and interstate standards adopted by the State Standard of Russia before July 1, 2003 are recognized as national.

Use of GOST USSR

By the Decree of the Supreme Council on the enactment of the Law of the Russian Federation "On Standardization" in 1993, it was established that before decisions were made on the transfer of the existing GOST USSR into the regulatory documents for the standardization of the Russian Federation, GOST USSR are applied insofar as they do not contradict the current legislation. In 2003, the current state and interstate standards, which were put into effect before July 1, 2003 for use in the Russian Federation, were recognized (the order was canceled in 2004) as national standards.

The provisions of the 1993 Law "On Standardization" were abolished with the introduction of the Law "On Technical Regulation". The application of interstate standards in Russia is regulated by this law: Art. 26 . At the same time, on the territory of the Eurasian Economic Union, interstate standards are applied voluntarily: p. one .

Use of interstate standards

Classification of standards

This system uses standard category index- GOST; for standards accepted only in Russia, the category index of the GOST R standard is used. The code of the standard itself consists of the number and year of approval of the standard, separated by a hyphen. The number is mainly determined by the adoption sequence or, if it is a systematized family, then the number contains the family code, a period and a number within the family. For example, a standard with a number containing the prefix "2." refers to the Unified System for Design Documentation (ESKD), "4." - to the System of Product Quality Indicators (SPKP), etc.

The All-Russian Classification of Standards (OKS) was developed by the All-Russian Research Institute for Classification, Terminology and Information on Standardization and Quality. It is the complete text of the International Classification of Standards (ICS) adopted by ISO.

Decree of the Government of the Russian Federation of December 29, 2007 No. 966 amended Decree of the Government of the Russian Federation of August 15, 2003 No. 500, approved a new version of the “Regulations on the Federal Information Fund of Technical Regulations and Standards” and a unified information system for technical regulation. The publication of standards on the Internet on the websites gost.ru and protect.gost.ru was started. But at the same time, Rostekhregulirovanie approached the publication of standards on its website formally: only scanned sheets of documents are available, inconvenient page navigation, and there is no text search.

On the official website of Rosstandart, free access to standards and changes to standards was opened, however, the documents are presented in low-resolution graphic copies, with “watermarks” and copy protection.

According to the results of the first half of 2016, Standardinform entered the top five largest publishing houses in Russia along with Eksmo, AST, Enlightenment, and Azbuka-Atticus.

see also

Notes

1. Annex No. 9 to the Treaty on the Eurasian Economic Union. Protocol on technical regulation within the framework of the Eurasian Economic Union
2. GOST 1.1-2002 Interstate standardization system. Terms and definitions of clause 4.1.1.3
3. Law "On technical regulation" Article 2. Basic concepts

FEDERAL AGENCY

ON TECHNICAL REGULATION AND METROLOGY

NATIONAL

STANDARD

RUSSIAN

FEDERATION

GOST R

(draft, first edition)

Arctic operations

This draft standard is not applicable until it has been adopted.

Moscow

Standartinform

201
Foreword

The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 N 184-FZ "On Technical Regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic Provisions»
About the standard
1 DEVELOPED by Gazprom VNIIGAZ Limited Liability Company (Gazprom VNIIGAZ LLC)
2 INTRODUCED by the Technical Committee for Standardization TC 23 "Equipment and technology for the production and processing of oil and gas"
3 APPROVED AND PUT INTO EFFECT by the Order of the Federal Agency for Technical Regulation and Metrology dated "__" _____ 20__ No. __
4 INTRODUCED FOR THE FIRST TIME

Information about changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments - in the monthly published information indexes "National Standards". In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notification and texts are also posted in the public information system - on the official website of the national body of the Russian Federation for standardization on the Internet

© "Standartinform", 2013

This standard cannot be fully or partially reproduced, replicated and distributed as an official publication without the permission of the Federal Agency for Technical Regulation and Metrology
Content

1 Scope………………………………………………………………………..1

3 Terms and definitions……………………………………………………………………….5

4 Abbreviations………………………………………………………………………………….6

5 General provisions…………………………………………………………………………..6

6 Design of personnel evacuation and rescue systems……………………………...14

7 Operation of personnel evacuation and rescue systems……………………………...…18

8 Personnel evacuation methods……………………………………………………………….20

9 Methods of rescue personnel………………………………………………………………….22

10 Personnel evacuation facilities…………………………………………………………….24

11 Personnel rescue equipment…………………………………………………………………………………………37

12 Training requirements for evacuation forces …………..…………………………………….….43

Bibliography…………………………………………………………………………………50
NATIONAL STANDARD OF THE RUSSIAN FEDERATION

Oil and gas industry

Arctic operations

Evacuation and rescue of personnel

Petroleum and natural gas industries. offshore production installation. Evacuation and rescue

Date of introduction ________________

1 area of ​​use

This standard is applicable to evacuation and rescue systems for personnel on offshore platforms operating in the waters of the Arctic seas, as well as other Russian seas with a cold climate, the hydrometeorological conditions of which are similar to those in the Arctic.

This standard specifies:

The main goals and objectives of the evacuation and rescue systems for offshore platform personnel;

Basic requirements for the design of evacuation and rescue systems;

Basic requirements for the operation of evacuation and rescue systems;

Classification of means of evacuation and rescue of offshore platform personnel;

Basic requirements for methods and means of evacuation and rescue;

Basic requirements for the training of offshore platform personnel and evacuation forces.

This standard uses normative references to the following standards:

GOST 12.0.002-80 Occupational safety standards system. Terms and Definitions

GOST 12.1.004-91 Occupational safety standards system. Fire safety. General requirements

GOST 12.1.006-84 Occupational safety standards system. Electromagnetic fields of radio frequencies. Permissible levels in the workplace and requirements for monitoring

GOST 12.1.018-93 Occupational safety standards system. Fire and explosion safety of static electricity. General requirements

GOST 12.1.044-89 System of labor safety standards. Fire and explosion hazard of substances and materials. Nomenclature of indicators and methods for their determination

GOST 12.2.007.0-75 Occupational safety standards system. Electrical products. General safety requirements

GOST 22.0.05-97 Safety in emergency situations. Man-made emergencies. Terms and Definitions

GOST 22.0.09-97 Safety in emergency situations. Emergencies in the waters. Terms and Definitions

GOST 27.003-90 Reliability in engineering. Composition and general rules for setting reliability requirements

GOST 29.05.002-82 System of standards for ergonomic requirements and ergonomic support. Digital sign-synthesizing indicators. General ergonomic requirements

GOST 10264-82 Light-signal fittings. General specifications

GOST 21786-76 "Man-machine" system. Signaling devices for sound non-verbal messages. General ergonomic requirements

GOST 21829-76 "Man-machine" system. Encoding of visual information. General ergonomic requirements

GOST 27900-88 Fixtures for emergency lighting. Technical requirements

GOST 31251-2008 External walls from the outside. Fire Hazard Test Method

GOST 31471-2011 Emergency door opening devices for evacuation and emergency exits. Specifications

GOST R ISO 7731-2007 Ergonomics. Danger signals for administrative and work premises. Acoustic danger signals

GOST R ISO 15544 Oil and gas industry. Offshore production units. Emergency response. Primary requirements

GOST R ISO 19906 (draft) Oil and gas industry. Structures of the Arctic shelf

GOST 18322-78 Maintenance and repair system for equipment, terms and definitions

GOST 21452-88 Parachute systems. Terms and Definitions

GOST R 51330.0-99 Explosion-proof electrical equipment. Part 0. General requirements

GOST R 52206-2004 Rescue equipment in the water area. Terms and Definitions

GOST R 52265-2004 Rescue equipment for crews of engineering structures operated in water areas. Classification

GOST R 52638-2006 Rescue equipment for crews of engineering structures operated in water areas. General technical requirements

GOST R 52928-2010 Global satellite navigation system. Terms and Definitions

GOST R 53451-2009 Means for saving crews of engineering structures operated in water areas, collective. Technical requirements

GOST R 54596-2011 Means of rescue for crews of engineering structures operated in water areas, individual. Technical requirements

GOST R 54117-2010 Global navigation satellite systems. Marine differential subsystems. Navigation equipment for consumers. Specifications, Methods and Required Test Results

GOST R 54118-2010 Global navigation satellite systems. Radio navigation systems for determining the spatial orientation of consumers in water transport. Specifications, Methods and Required Test Results

GOST R 54119-2010 Global navigation satellite systems. Ship multisystem, multichannel consumer equipment GNSS GLONASS/GPS/GALILEO. Specifications, Methods and Required Test Results

GOST R 54483-2011 (ISO 19900:2002) Oil and gas industry. Offshore platforms for oil and gas production. General requirements

GOST R 55564-2013 Means for picking up people from the water surface when rescuing crews of engineering structures operated in water areas. General technical requirements

GOST R 55946-2014 Means for rescuing crews of engineering structures operated in water areas, individual. General specifications

GOST R 50799-95 Electromagnetic compatibility of technical means. Resistance of technical means of radio communication to electrostatic discharges, impulse noise and dynamic changes in the voltage of the power supply network. Requirements and test methods

GOST R 50932-96 Electromagnetic compatibility of technical means. Immunity of wired communication equipment to electromagnetic interference. Requirements and test methods

GOST R IEC 60945-2007 Marine navigation and radio communications equipment. General requirements. Test Methods and Required Test Results

GOST 32455-2013 Global navigation satellite system. Marine navigation equipment for consumers. receiving devices. General requirements, methods and required test results

GOST R XXXXXXXXX Oil and gas industry. Arctic operations. Maintenance of objects

GOST R XXXXXXXXX Oil and gas industry. Arctic operations. Working environment

GOST R XXXXXXXXX Oil and gas industry. Arctic operations. Topsides of offshore platforms

GOST R XXXXXXXXX Oil and gas industry. Evacuation and rescue from offshore production installations. Terms and Definitions

GOST R XXXXXXXXX Oil and gas industry. Offshore production units. Escape routes and temporary shelters. Primary requirements

Note - When using this standard, it is advisable to check the operation of reference standards and classifiers in the public information system - on the official website of the national body of the Russian Federation for standardization on the Internet or according to the annually published information index "National Standards" , which is published as of January 1 of the current year, and according to the corresponding monthly published information indexes published in the current year. If the reference document is replaced (modified), then when using this standard, you should be guided by the replaced (modified) document. If the referenced document is canceled without replacement, the provision in which the link to it is given applies to the extent that this link is not affected.

3 Terms and definitions

This standard uses the terms established in accordance with GOST 12.0.002, GOST R 52206, GOST 22.0.05, GOST 22.0.09, GOST 21452, GOST R XXXX, GOST R ISO 15544 and GOST R 55311, as well as the following terms with the corresponding definitions:

3.1 evacuation life support system: A set of means and measures that ensure the maintenance of the energy and mass exchange of the human body with the environment in the habitable compartment of the means of evacuation at the level necessary to maintain its health and performance;

3.2 habitable evacuation compartment: Compartment of the means of evacuation, designed to ensure the conditions of human life;

3.3living conditions in the means of evacuation: The set of environmental parameters in the means of evacuation, the maintenance of which ensures the preservation of human health and the maintenance of its performance at the level necessary to perform the tasks of evacuation and rescue;

3.4 navigation support for evacuation/rescue: A set of measures carried out in order to create and maintain favorable conditions for the navigation of evacuation/rescue means;

3.5 air rescue landing pad: A piece of land, water or other surface suitable for the takeoff and landing of an air rescue device;

3.6special training for the evacuation vehicle crew: A system of measures for the preparation of crews of evacuation vehicles for the performance of special tasks for the evacuation of offshore platform personnel using special equipment installed on the evacuation vehicle;

3.7prevention of icing of means of evacuation/rescue: Measures to protect surfaces of means of evacuation/rescue for a limited period of time from ice formation and snow accumulation;

3.8removal of icing of means of evacuation/rescue: The procedure for removing ice, snow or ice deposits from the surfaces of means of evacuation/rescue. This procedure can be performed mechanically, pneumatically, or with heated fluids;

3.9 anti-icing protection of means of evacuation/rescue: A set of measures, including the processes of removal and prevention of icing;

3.10 medical support for evacuation: a set of measures aimed at protecting the health of offshore platform personnel and providing medical assistance to victims during the evacuation of personnel from the offshore platform;

3.11 rescue medical support: a set of measures aimed at protecting the health of offshore platform personnel and providing medical assistance to those injured during the rescue of offshore platform personnel.

4 Abbreviations

The following abbreviations are used in this standard:

VU - temporary shelter;

GG - combustible gas;

GZH - combustible liquid;

POL - fuels and lubricants;

GLONASS - global navigation satellite system;

GMDSS - Global Maritime Distress Communication System;

Flammable liquid - flammable liquid;

MP - offshore platform;

MDU - offshore production unit;

HVAC - heating, ventilation and air conditioning;

Software - software;

PBU - floating drilling rig;

RS - Russian Maritime Register of Shipping;

RLE flight manual;

VTS traffic management service;

AARB aviation emergency radio beacon-location indicator;

EPIRB maritime emergency position indicator beacon;

RLO radar search and rescue transponder;

SOLAS International Convention for the Safety of Life at Sea.

5 General provisions

5.1 The main objectives of the evacuation system and the rescue system for the MP personnel are:

Preservation of life and health of MP personnel in case of incidents, accidents and emergency situations;

Prevention of environmental pollution as a result of accidents at MPs;

Minimization of damage caused by accidents at MPs and reduction of the time for liquidation of their consequences.

5.2 The main tasks of the MP personnel evacuation system are:

Planning activities for the evacuation of MP personnel;

Managing the evacuation of MP personnel;

Ensuring the readiness of forces and means of evacuation of the MP;

Ensuring the readiness of evacuation routes and VU MP;

Ensuring readiness of MP personnel for actions during evacuation;

Material support for the evacuation of MP personnel;

Transfer of victims of an accident at the MP to the means of evacuation;

Navigation support for evacuation;

Medical support for evacuation;

Interaction with the coastal headquarters to provide assistance to the MP in an emergency;

Interaction with the marine rescue coordination center, as well as other organizations providing assistance from the shore.

5.3 Planning of measures for the evacuation of MP personnel

5.3.1 Planning of measures for the evacuation of the personnel of the Marine should provide for:

Development of evacuation plans for MP personnel;

Regular updating and adjustment of the evacuation plans for the personnel of the Marine Corps, taking into account the practical experience of carrying out activities for the evacuation of the personnel of the Marine Corps in similar conditions, as well as the experience of conducting exercises at the Marine Corps.

5.3.2 Planning of measures for the evacuation of the personnel of the Marine should be aimed at ensuring the most efficient and coordinated use of forces and means of evacuation.

5.3.3 The development of a plan for the evacuation of the personnel of the MP should include the following steps:

Assessment of possible evacuation conditions;

Choice of evacuation methods;

Choice of means of evacuation;

Planning of evacuation measures;

Estimated estimated time required for evacuation.

5.3.4 The evacuation plans for the personnel of the Marine should:

Satisfy the requirements of international and national documents regulating the protection of human life at sea;

Cover all stages of evacuation;

Take into account the characteristics of the means of evacuation;

Be consistent with the current documents developed for the purpose of rescuing MP personnel;

Take into account the hydrometeorological conditions in the area where the MP is located and the possible state of the MP evacuation routes for the period of the evacuation;

Presented in a form that provides ease of use and control.

5.3.5 The SP personnel evacuation plan must contain the following information:

Distribution of organizational functions and responsibilities between the participants in the evacuation of MP personnel;

Description of the main types of interaction between evacuation forces and methods of communication between them;

Description of evacuation methods;

List and characteristics of the means of evacuation used;

Locations of means of evacuation;

Characteristics of the VU and their location on the MP;

Location and characteristics of escape routes.

5.4 Ensure the readiness of the evacuation forces

5.4.1 Ensuring the readiness of the evacuation forces should include:

Creation of a training system for emergency rescue units and crews of MT evacuation equipment aimed at mastering technologies, techniques and methods of evacuation from MT;

Creation of a system for training MP personnel for actions during evacuation;

Equipping rescue teams with the necessary property and means of communication;

Checking the readiness of the evacuation forces through systematic drills and exercises.

5.4.2 The elements of the training system for emergency rescue teams are:

Professional selection;

Education;

Workout;

Exchange of experience between participants in the evacuation of MP personnel in Arctic conditions;

Formation of a team (teams, parties) for their joint activities.

5.4.3 General requirements for professional selection in accordance with GOST R XXX ... Working environment.

5.5 Ensuring the readiness of means of evacuation should include:

Maintenance of means of evacuation;

Regular health checks;

Timely repair/replacement of faulty units and mechanisms;

Control of the technical condition of the means of evacuation by the relevant state control body;

Preparation of means of evacuation for use;

Filling with fuel, oil, liquids and gases;

Protection of means of evacuation from the damaging factors of an accident at the MP.

5.6 General requirements for the training of crews of means of evacuation are set out in Section 12.

5.7 Ensuring the readiness of the MP personnel for actions during evacuation should include:

Establishment of an effective system for training MP personnel;

Equipping MP personnel with personal protective equipment and means of communication;

Checking the readiness of MP personnel through systematic training and exercises.

5.7.1 The elements of the system for training the personnel of the Marine for actions during evacuation are:

Professional selection;

Education;

Workout;

5.7.2 General requirements for professional selection in accordance with GOST R XXX ... Working environment.

5.7.3 General requirements for the training of MP personnel for evacuation actions are set out in Section 12.

5.8 The material support for the evacuation of the SP personnel should include:

Forecasting and determining the need for material resources;

Organization of the issuance of material resources to direct consumers;

Providing personnel with an emergency supply of food and water in accordance with physiological norms, taking into account the volume and intensity of work performed during evacuation and rescue, as well as Arctic climatic conditions;

Additional provision of evacuated personnel with means to prevent hypothermia.

5.9 The transfer of victims of an accident at the MP to the means of evacuation should be ensured by the following measures:

Providing means of transportation for victims;

Preparing victims for transportation;

Ensuring the protection of those affected by the action of the damaging factors of the accident at the MP;

Ensuring the protection of victims from negative environmental factors;

Loading victims into evacuation vehicles.

5.10 Navigation support for evacuation should include:

Equipping the MP with navigation aids;

Operational maintenance of navigation aids;

Ensuring the stable operation of navigation aids in an emergency at the MP.

5.11 Medical support for evacuation

5.11.1 Medical support for evacuation should include the following measures:

Preparation of places for placement and provision of emergency medical care (first aid) to victims of an accident at the MP in the VU and means of evacuation;

Creation of stocks of emergency medical aid (first aid) and medicines in accordance with established standards in the places of accommodation of victims;

Storage, accounting and quality control of emergency medical aid (first aid) and medicines;

Determination of persons responsible for providing first aid in emergency situations and the transfer of information about the medical care already provided before further transportation of the victims;

Storage, accounting and control of the use of potent and psychotropic medicines, indicating the responsible persons who have the right to use them to provide first aid to victims;

Sorting of victims of the accident at the MP;

Providing emergency medical care (first aid) to the victims;

Registration of victims;

Preparation of victims for transportation to medical organizations for the provision of specialized medical care.

5.11.2 Preparation of places for placement and provision of emergency medical care (first aid) to victims of an accident at the MP in the VU should provide for the creation of appropriately equipped zones:

Collection areas for casualties;

triage areas;

Areas for the provision of emergency medical care (first aid);

Areas for the preparation of victims for transportation.

5.12 The main tasks of the MP personnel rescue system are:

Reception, confirmation and relaying of emergency notifications (accident signal) from MP;

Notification of authorized state bodies about the accident at the MP;

Planning of work to rescue the MP personnel;

Management of work on rescue of MP personnel;

Ensuring interaction with public authorities;

Ensuring the readiness of forces and means of rescue;

Ensuring the preparedness of the MP personnel for rescue operations;

Ensuring readiness of MP personnel for actions after evacuation and for survival in conditions of autonomous existence;

Material support for rescue;

Ensuring the supply of life-saving equipment and life support for the personnel of the Marine after evacuation to the ice/shore;

Transfer of victims of an accident at the MP to medical institutions;

Information support of rescue;

Navigation support for rescue;

Medical support of rescue;

Informing the public and the media about the progress of work to rescue the MP personnel;

Improvement of methods and means of rescue.

5.13 The body that manages the evacuation and rescue of MP personnel must:

Register operational information;

Provide operational information to crews of rescue equipment and members of emergency rescue teams;

Maintain a chronological record of all actions taken;

Determine the priority of tasks;

Notify authorized state bodies;

Conduct interaction with public authorities;

Correct the plan of rescue operations taking into account the conditions of the external environment and constantly inform the emergency rescue teams about adjustments to the plan for the rescue operations;

Plan routes for the movement of rescue equipment;

Monitor the state of the communication system;

Analyze the hydrometeorological situation in the area of ​​work to rescue the personnel of the Marine, in the places where the rescue equipment is based and on the routes of the rescue equipment, inform the crews of the rescue equipment about its changes;

Control the location and degree of readiness of rescue forces and equipment on duty;

Decide on the involvement of additional forces and means of third-party organizations located in the emergency area or in close proximity to it.

5.14 Planning for the rescue of MP personnel

5.14.1 Planning of rescue operations by the MF personnel should provide for:

Development of a rescue plan;

Regular updating and adjustment of plans for rescue operations, taking into account the practical experience of conducting rescue operations in similar conditions, as well as the experience of conducting exercises on the MP.

5.14.2 Development of a rescue plan should include the following steps:

Assessment of possible rescue conditions;

Choice of rescue methods;

Choice of means of rescue;

The division of the area of ​​work to rescue the personnel of the MP into sub-areas, and the distribution of the forces and means of rescue by sub-areas;

Planning of actions in the area (sub-area) of work to rescue the MP personnel;

Assessing the risks of environmental pollution in various accident scenarios, developing measures to reduce them and ensure minimization of the consequences of possible pollution.

5.14.3 The rescue plan should:

Satisfy the requirements of international documents regulating the protection of human life at sea;

Cover the entire period of work to rescue the personnel of the MP;

Take into account all scenarios of emergency situations at the MP;

Take into account the characteristics of the current system of evacuation of personnel from the MP;

Be consistent with the current plan for the evacuation of personnel from the MP;

Presented in a form that provides ease of use.

5.14.4 In general, the rescue plan should contain the following information:

Distribution of organizational functions and responsibilities between the participants in the rescue of MP personnel;

The rights of participants in the rescue of MP personnel;

Description of the methods of carrying out work to rescue the MP personnel;

Attracted means of rescue and their location;

Routes for the movement of rescue equipment to the area of ​​work to rescue the MP personnel;

Possible redeployment of rescue equipment caused by changes in meteorological or ice conditions;

List of rescue equipment used, its location and application procedure;

Methods of delivery of rescue equipment to the area of ​​work on rescue MP personnel;

Methods of emergency notification of ships and aircraft located or following in the area of ​​work to rescue the personnel of the MP;

Possible locations of the MP personnel after the accident;

The procedure for obtaining weather reports and weather forecasts;

guidance methods for aviation rescue equipment;

Measures for interaction with interested departments, air and sea traffic management, navigation support, pilotage, VTS and port services;

Other required information.

5.15 Ensuring readiness of the MP personnel for actions after evacuation and for survival in conditions of autonomous existence

5.15.1 Ensuring the readiness of the MP personnel for actions after evacuation and for survival in conditions of autonomous existence should include:

Creation of an effective system for training personnel for actions after evacuation and for survival in conditions of autonomous existence;

Equipping with means of life support in conditions of autonomous existence.

5.15.2 The elements of the system for training the personnel of the Marine for survival in conditions of autonomous existence after evacuation are:

Professional selection;

Education.

5.15.3 General requirements for professional selection in accordance with GOST R XXX ... Working environment

5.15.4 The general requirements for training the personnel of the Marine to survive in conditions of autonomous existence after evacuation are set out in Section 12.

5.16 Material support for rescue should include:

Forecasting and determination of the need for material resources in the course of work to rescue the MP personnel;

Creation of stocks of material resources, in accordance with established standards;

Storage, accounting and quality control of material assets;

Organization of the issuance of material resources to direct consumers;

Organization of the delivery of material support to the area of ​​work to rescue the MP personnel.

5.17 Provision of life-saving equipment and life-sustaining equipment for the SP personnel after evacuation to the ice/shore should provide for:

A set of measures for the preparation of rescue equipment and life support means for transportation to the area of ​​work to rescue the MP personnel;

Ensuring the readiness of vehicles for the delivery of rescue equipment and life support equipment;

Delivery of life-saving equipment and life support means to the area of ​​operations to rescue MP personnel.

5.18 Medical support for rescue

5.18.1 Medical support for rescue should include the following measures:

Preparation of places for placement and provision of emergency medical care (first aid);

Creation of stocks of emergency medical aid (first aid) and medicines in accordance with established standards in the places of accommodation of victims;

Organization of remote consultations using IT technologies (if necessary);

Organization of accounting and storage of emergency medical aid (first aid) and medicines;

Providing emergency medical care (first aid);

Preparation of the victim for transportation to medical organizations for the provision of specialized medical care;

Transportation of victims to medical organizations for the provision of specialized medical care.

5.18.2 Transportation of victims of an accident at the MP to medical organizations should include:

Loading and placement of victims in rescue equipment;

Monitoring the condition of victims during transportation in rescue equipment;

Providing emergency medical care (first aid) during transportation in rescue equipment.

5.19 Information support for rescue should include:

Provision of climatic data with statistically processed and systematized over a number of years information about the hydrometeorological regime in the area of ​​rescue operations for the MP personnel and on the routes of rescue equipment;

Provision of weather data with information about the actual hydrometeorological situation in the area of ​​work to rescue the personnel of the Marine and on the routes of movement of rescue equipment, as well as a forecast of changes in the hydrometeorological situation for a period of time during which work is carried out to rescue the personnel of the Marine;

Provision of navigational recommendations, warnings about adverse and dangerous hydrometeorological phenomena, the impact of which can lead to death of people, damage to rescue equipment and a significant decrease in the efficiency of work to rescue the MP personnel.

Approved and put into effect by order of the Federal Agency for Technical Regulation and Metrology dated August 17, 2017 N 920-st

National standard of the Russian Federation GOST R 1.17-2017

"STANDARDIZATION IN THE RUSSIAN FEDERATION. EXPERT ON STANDARDIZATION. GENERAL REQUIREMENTS"

Standardization in the Russian Federation. Expert for standardization. General requirements

Instead of GOST R 1.17-2015

Foreword

1 Developed by the Federal State Unitary Enterprise "All-Russian Research Institute for Standardization and Certification in Mechanical Engineering" (VNIINMASH)

2 Introduced by the Technical Committee for Standardization TC 12 "Standardization Methodology"

3 Approved and put into effect by the Order of the Federal Agency for Technical Regulation and Metrology dated August 17, 2017 N 920-st

4 Instead of GOST R 1.17-2015

1 area of ​​use

This standard establishes general requirements for the work of a standardization expert, including his functions, as well as requirements for a candidate for experts, for the competence of an expert and for his professional skills.

This standard is used in preparation for the certification of personnel for compliance with the requirements for standardization experts, and in carrying out this certification.

2 Normative references

This standard uses normative references to the following standards and classifier:

GOST 1.1 Interstate standardization system. Terms and Definitions

GOST 1.3 Interstate standardization system. Interstate standards. Development rules based on international and regional standards

GOST 1.5 Interstate standardization system. Interstate standards, rules and recommendations for interstate standardization. General requirements for construction, presentation, design, content and designation

GOST 8.417 State system for ensuring the uniformity of measurements. Units

GOST R 1.2 Standardization in the Russian Federation. National standards of the Russian Federation. Rules for Development, Approval, Update, Amendment, Suspension and Cancellation

GOST R 1.5 Standardization in the Russian Federation. national standards. Rules for construction, presentation, design and designation

GOST R 1.6 Standardization in the Russian Federation. Draft standards. Rules for organizing and conducting an examination

GOST R 1.7 Standardization in the Russian Federation. national standards. Rules for design and designation in the development based on the application of international standards

GOST R 1.8 Standardization in the Russian Federation. Interstate standards. Rules for conducting work in the Russian Federation on the development, application, updating and termination of application

GOST R 1.16 Standardization in the Russian Federation. National preliminary standards. Rules for the development, approval, application and cancellation

OK (MK (ISO / INFCO MKS) 001-96) 001 All-Russian classifier of standards

Note - When using this standard, it is advisable to check the validity of reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or according to the annual information index "National Standards", which was published as of January 1 of the current year, and on issues of the monthly information index "National Standards" for the current year. If an undated referenced reference standard has been replaced, it is recommended that the current version of that standard be used, taking into account any changes made to that version. If the reference standard to which the dated reference is given is replaced, then it is recommended to use the version of this standard with the year of approval (acceptance) indicated above. If, after the adoption of this standard, a change is made to the referenced standard to which a dated reference is given, affecting the provision to which the reference is given, then this provision is recommended to be applied without taking into account this change. If the reference standard is canceled without replacement, then the provision in which the reference to it is given is recommended to be applied in the part that does not affect this reference.

3 Terms and definitions

This standard uses the terms according to GOST 1.1, as well as the following term with the appropriate definition:

3.1 standardization expert: A person who has the knowledge and experience to carry out standardization work and whose qualifications are confirmed within the framework of voluntary certification systems.

4 Functions of a standardization expert

4.1 The main activities of a standardization expert are:

Examination of draft standards of all levels* and amendments to them;

Examination of draft specifications and amendments to them;

Normative control of draft national and interstate standards and amendments to them;

Participation in the development, modification, cancellation, preparation for approval, application of standards and specifications;

Participation in the work of the interstate and (or) national technical committee for standardization or project technical committee for standardization;

Carrying out consultations and other explanatory work on the application and content of standardization documents.

4.2 Additional activities that a standardization expert may carry out include:

Examination of draft sets of rules, information and technical reference books, all-Russian classifiers of technical, economic and social information, standardization rules and recommendations for standardization and amendments to them, as well as draft technical regulations;

Participation in the formation of lists of documents in the field of standardization, as a result of which, on a voluntary basis, compliance with the requirements of technical regulations is ensured, and lists of documents in the field of standardization, which contain the rules and methods of research (testing) and measurements necessary for the application and execution of technical regulations and the implementation conformity assessment;

Standard control of technical documentation;

Conducting lectures or teaching work on issues related to standardization;

Preparation of articles, monographs and reports, the content of which relates to various aspects of standardization.

5 Requirements for a candidate for standardization expert

5.1 A candidate expert must have the necessary competence to perform the functions specified in Section 4 and have a higher professional education, confirmed by a state document.

5.2 A candidate expert must have a previous practical experience in the field of standardization for at least three years.

5.3 A candidate expert should receive specific training in the field of standardization.

5.4 A candidate for standardization expert should have the following personal qualities:

Have a broad outlook and know the rules of business etiquette;

Be objective and impartial;

Have a sense of responsibility for the work being done;

Be able to clearly and freely express their thoughts both in writing and orally.

Note - The personal qualities of a candidate for standardization experts are reflected in the description from the main place of his work.

6 Requirements for the competence of a standardization expert

6.1 The standardization expert should know:

The laws of the Russian Federation relating to the methodology of standardization and metrology, regulatory legal acts of the Government of the Russian Federation, the federal executive body responsible for developing state policy and legal regulation in the field of standardization, and the federal executive body in the field of standardization, as well as the laws of the Russian Federation, regulatory legal acts of the Government of the Russian Federation, other federal executive bodies that relate to the area of ​​activity of an expert at his main place of work;

Fundamental national standards of the Russian Federation and national standards included in the "Standardization in the Russian Federation" complex;

Interstate standards included in the complex "Interstate standardization system";

General technical systems of standards that establish the rules for the development and production of products for production, labor protection and the environment in relation to their field of activity;

Directions and basic principles of international cooperation in the field of standardization;

Rules for carrying out work on international and regional standardization, including general rules for the development and application of international and European standards in the Russian Federation;

Features of carrying out work on standardization in their field of activity.

6.2 The standardization expert must constantly keep his knowledge up to date in the process of participating in standardization work, as well as by:

Training in specialized advanced training courses;

Participation in thematic seminars, conferences, etc.;

Self-raising the level of knowledge in the field of standardization methodology, including by reviewing periodicals published in the field of standardization.

7 Skills requirements for a standardization expert

The standardization expert should be able to:

To conduct an examination of draft standards of all levels and technical specifications for the profile of the expert in the scope established in GOST R 1.6;

Check compliance with the principle of inadmissibility of developing national standards of the Russian Federation for objects and aspects of standardization that are already standardized or can be standardized at the interstate level;

To check compliance with the requirements of GOST R 1.5 and (or) GOST 1.5 to the structure, presentation, design and content of the developed standard;

To check compliance with the development of a national or interstate standard based on the application of an international, regional, foreign national standard or other document of the rules established in GOST R 1.7 or GOST 1.3;

Check compliance with the rules for developing standards of the appropriate level, established in GOST R 1.2, GOST R 1.8, GOST R 1.16;

Identify contradictions between the developed standard and the requirements of the current national standards of the Russian Federation and other regulatory documents in force at the federal level;

Identify duplication with the current national standards of the Russian Federation and interstate standards acting in this capacity, as well as with sets of rules, and prepare proposals for replacing duplicated provisions with references to these standards (sets of rules);

Reveal the relationship of the developed standard with other simultaneously developed and existing national and interstate standards and codes of practice;

Verify the use of standardized materials and products, test methods, packaging, marking, technological methods and documentation forms in the standard being developed;

Check compliance with the use in the draft standard of terms standardized at the national level *, as well as the absence of contradictions between the standardized terms and the terms that are defined and (or) used in the developed standard;

Check the application of the names and designations of units of measurement, which are established in GOST 8.417 and in the regulation approved by the Government of the Russian Federation on units of quantities allowed for use in the Russian Federation;

Control the compliance of the sign and linguistic means used in the standard with the norms and rules of the Russian language (spelling, lexical, derivational, syntactic and stylistic);

Prepare draft national and interstate standards;

Apply OK (MK (ISO/INFCO ISS) 001-96) 001 in your work.

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* A term standardized at the national level is considered to be a term established in the national standard of the Russian Federation for terms and definitions or in the interstate standard for terms and definitions acting in this capacity.

Bibliography

Decree of the Government of the Russian Federation of October 31, 2009 N 879 "On approval of the Regulations on units of quantities allowed for use in the Russian Federation"

GOST R 53434-2009

Group T58
T51

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

PRINCIPLES OF GOOD LABORATORY PRACTICE

Principles of good laboratory practice

Introduction date 2010-03-01

Foreword

The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 N 184-FZ "On Technical Regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic Provisions".

About the standard

1. Prepared by the Scientific Institution "Research Center for Standardization, Information and Certification of Raw Materials, Materials and Substances" based on its own authentic translation into Russian of the guidance document specified in paragraph 4.

2. Introduced by the Technical Committee for Standardization TC 100 "Strategic and innovative management".

3. Approved and put into effect by Order of the Federal Agency for Technical Regulation and Metrology dated December 2, 2009 N 544-st.

4. This standard is identical to the guidance document of the Organization for Economic Co-operation and Development (OECD) "Principles of Good Laboratory Practice" ("OECD. PRINCIPLES OF GOOD LABORATORY PRACTICE").

5. Introduced for the first time.

Information about changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments - in the monthly published information indexes "National Standards". In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notification and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet.

Introduction

This standard "Principles of Good Laboratory Practice" was prepared in order to harmonize domestic norms and rules with international documents and, first of all, with the document of the Organization for Economic Cooperation and Development (OECD) "Principles of Good Laboratory Practice (GLP)".

The dissatisfaction of governments and industry representatives of different countries with the quality of non-clinical studies, on the results of which the assessment of the level of danger to human health and the environment is based, was the reason for the establishment of criteria by OECD member states for conducting such studies.

In order to avoid the use of different schemes for the implementation of such studies, which could interfere with the international trade in chemicals, the OECD member states have set the goal of international harmonization of test methods and good laboratory practice. In 1979 - 1980. An international panel of experts established under the Special Program on Chemicals Control developed the OECD Good Laboratory Practice (GLP) document, using organizational and scientific methods and experience gained from various national and international sources. These "GLP Principles" were adopted by the OECD Council in 1981 as an addendum to the OECD Council decision on mutual acceptance of data in the evaluation of chemicals.

In 1995 - 1996 a new expert group was formed to revise the Good Laboratory Practice (GLP) Principles. An updated version of the document has been developed based on the consensus reached by this group of experts. This document cancels and replaces the original Good Laboratory Practice (GLP) document, adopted in 1981.

The purpose of the Principles of Good Laboratory Practice (GLP) is to promote the application of the principle of evaluating the quality of test data. The comparability of the level of quality of the data obtained as a result of the tests forms the basis for the mutual acceptance of data in different countries. If individual countries can confidently rely on test data from other countries, duplicate testing can be avoided, saving time and resources. The application of the "Good Laboratory Practice Principles (GLP)" will avoid the creation of technical barriers to trading activities and will contribute to the protection of human health and the environment.

1 area of ​​use

This International Standard establishes the principles of good laboratory practice for use in non-clinical testing of items contained in drugs, pesticides, cosmetics, veterinary drugs, food and feed additives, and industrial chemicals. The test objects can be both of a synthetic nature and of a biogenic origin, and also represent living organisms. The purpose of testing is to obtain data on the properties of the test objects and/or their safety for human health and/or the environment.

Non-clinical trials in the field of medical and environmental safety, covered by the principles of good laboratory practice, include studies conducted in laboratory, greenhouse and field conditions. The principles of good laboratory practice apply to all health and environmental testing conducted for the purposes of registration and licensing of medicines, pesticides, food and feed additives, cosmetics, veterinary drugs and other similar products, and industrial chemicals, with the exception of cases expressly provided for under national law.

2. Terms and definitions

In this standard, the following terms are used with their respective definitions:

2.1. Principles of Good Laboratory Practice

2.1.1. Principles of good laboratory practice (Good Laboratory Practice (GLP): quality assurance system related to the processes of organizing, planning, conducting and controlling tests in the field of human health and environmental safety, as well as registration, archiving and presentation of the results of these tests.

2.2. Organization of test centers

2.2.1. The actual location of non-clinical trials, where the team of specialists, premises and equipment necessary for their implementation should be located. If a test is carried out at several test sites, and not at one place, then the term "test center" means the center where the test director and all test sites, individually and collectively considered as test centers, should be located. Testing center (An organization that has the necessary material and technical base and qualified personnel to conduct preclinical (non-clinical) studies in the relevant field. test facility): the actual location of non-clinical trials, where the team of specialists, premises and equipment necessary for their implementation should be located. If a test is carried out at several test sites and not at one location, then the term "test center" means the center where the test director and all test sites, individually and collectively considered as test centers, should be located.

2.2.2. test site (Location of any research. test site): the location of any stage of the study.

2.2.3. The person or persons formally in charge of a test facility and responsible for organizing and maintaining good laboratory practice within it. Test center administration (The person(s) who has the authority and formal responsibility for the organization and operation of the laboratory in accordance with the specified rules of Good Laboratory Practice. test facility management): the person or persons formally in charge of the test facility and responsible for organizing and maintaining good laboratory practice within it.

2.2.4. The person or persons formally in charge of the test site and responsible for the conduct of the relevant phases of the test site in accordance with the principles of Good Laboratory Practice. Test Site Administration ((If designated) is the person(s) responsible for overseeing the study step(s) for which they are responsible and conducting the study in accordance with good laboratory practice. test site management): the person or persons officially in charge of the test site and responsible for conducting the relevant stages of research on it in accordance with the principles of good laboratory practice.

2.2.5. Sponsor ( An entity that commissions, provides financial support for, and/or requests a pre-clinical, non-clinical safety study for human health and the environment. sponsor): the natural or legal person who initiates research, orders, supports and/or approves the conduct of non-clinical research and is responsible for its organization and financing.

2.2.6. Study leader (The person responsible for conducting a non-clinical health and environmental safety study from start to finish. study director): a person responsible for conducting a non-clinical study in the field of health and environmental safety from start to finish.

2.2.7. Responsible Researcher (The person who, in the case of multi-site studies, acts on behalf of the Study Director and is responsible for the assigned study phases. [NOTE - The responsible investigator(s) cannot be fully delegated the responsibility of the principal investigator for conducting the study, as this includes approving the study plan and amendments to that plan, approving the final report, and ensuring that all studies comply with the principles of good laboratory practice.] principal investigator): the person who, in the case of multi-site studies, acts on behalf of the study director and is responsible for the phases of the study delegated to him.

Note 1 to entry: The responsible investigator(s) cannot be fully delegated the responsibility of the study director for conducting the study, as this includes approving the study plan and amendments to that plan, approving the final report, and ensuring that all studies comply with the principles of good laboratory practice.

2.2.8. Quality Assurance Program ( A set of measures aimed at compliance with these rules by staff and is intended to ensure the management of the laboratory in accordance with the rules of good laboratory practice. quality assurance program): a program of work carried out by personnel independent of research and aimed at ensuring that the administration of the test center adheres to the principles of good laboratory practice.

2.2.9. standard operating procedures; SOP ( Detailed written instructions describing test procedures or other activities, usually not detailed in study plans or testing manuals, and intended to achieve uniformity in the performance of certain activities. standard operating procedures; SOPs): Detailed written instructions describing test procedures or other activities, usually not presented in detail in study plans or test manuals, and intended to achieve uniformity in the implementation of certain activities.

2.2.10. Master Schedule (The work schedule of the generalizing level, which includes enlarged stages and key events, i.e. a summary of information that allows an estimate of the workload and is used to control the conduct of studies in the test center. master schedule): work schedule of a generalizing level, which includes enlarged stages and key events, i.e. a summary of information that allows an estimate of the workload and is used to control the conduct of studies in the test center.

2.3. Non-clinical study of medical and environmental safety

2.3.1. An experiment or series of experiments in which a test item is subjected to laboratory, greenhouse or field testing in order to obtain data on the properties of the item and/or its safety and submit it to regulatory authorities. Non-clinical study of medical and environmental safety; study(non-clinical health and environmental safety study): An experiment or series of experiments in which a test item is subjected to research in a laboratory, greenhouse or field to obtain data on the properties of the item and / or its safety and submit them to regulatory authorities.

2.3.2. Short term study (Research conducted by widely used standard methods for a short time. short term study): research carried out by widely used standard methods for a short time.

2.3.3. Study plan (A document describing the purpose and methodology of the experiment for conducting the study, and including any amendments made to it. study plan): A document describing the purpose and methodology of an experiment for conducting a study and including any amendments made to it.

2.3.4. Study Plan Amendment (A purposeful change to the design of a study made after the start of the study. study plan amendment): A purposeful change in the design of a study made after the start of the study.

2.3.5. Unintentional deviation from the study plan after the start of the study. Deviation from the study plan(study plan deviation): an unintentional deviation from the study plan after the start of the study.

2.3.6. Test system (A biological, chemical, or physical system, alone or in combination, used in research. test system): a biological, chemical, or physical system, alone or in combination, used in research.

2.3.7. Primary research data (Original records and documents of the test center or certified copies thereof, reflecting the results of observations and procedures carried out during the study. [Note - Primary research data can be: photographs, microfilms, microfilms, their copies, diskettes and CDs, work records, including records of automated instrument readings, and other data carriers that provide secure storage of information for a certain period of time.] raw data): original records and documents of the testing center or their certified copies, reflecting the results of observations and procedures carried out during the study.

Note - The primary research data can be: photographs, microfilms, microfilms, their copies, diskettes and CDs, work records, including records of automated instrument readings, and other data carriers that ensure the safe storage of information for a certain period of time (see. 2.3.10).

2.3.8. Specimen: Any material taken from a test system for examination, analysis, or storage.

2.3.9. Experiment start date (Date of receipt of the first experimental data. experimental starting date): date of receipt of the first experimental data.

2.3.10. Experimental completion date: The date when the last experimental data was received.

2.3.11. Study start date (The date the study director signed the study plan. study initiation date): the date the study director signed the study plan.

2.3.12. Study end date (The date the Study Director signed the Final Report. study completion date): date of signing of the final report by the Study Director.

2.4. Test object (subject or object under test)

2.4.1. Object under test ( An object that is the subject of research. test item): an object that is the subject of research.

2.4.2. Standard object (sample), "control" object (sample) (reference item, "control item"): an object (sample) used for comparison with the test object, having an officially (legally) certified composition.

2.4.3. Party, series (A specified quantity of a test or reference item obtained during a specified production run in such a way that the item is of a uniform nature. batch, lot): a specified quantity of a test or reference item obtained during a specified production run in such a way that the item has a uniform character.

2.4.4. Carrier (A substance used to mix, disperse, or dissolve a test or reference item and to facilitate its introduction into a test system. vehicle): a substance used to mix, disperse or dissolve a test or reference object and to facilitate its introduction into a test system.

3. Purpose and application

3.1. The principles of good laboratory practice, which are a system of norms, rules and guidelines, are designed to ensure the consistency and reliability of the results of non-clinical (preclinical, laboratory, experimental) studies.

3.2. The principles of good laboratory practice are defined as a quality assurance system relating to the organization of the testing process and the conditions in which non-clinical health and environmental safety studies should be planned, performed, controlled and recorded.

3.3. The principles of good laboratory practice apply to the work of pharmacological, toxicological and other biological laboratories, as well as to research in the field of industrial toxicology, namely the study of the properties of chemical compounds used in the production of consumer (non-drug) products in order to assess their potential hazard to human health and the state of the environment.

3.4. The principles of good laboratory practice are aimed at ensuring the acceptability of research results at the stage of experimental study of new drugs. Acceptability in this case means, on the one hand, evidence and reliability of the data, on the other hand, compliance with the principles of humane treatment of laboratory animals.

3.5. An organization dealing with the study of chemical and biological safety of both classical chemicals and biotechnological, genetically modified and nanotechnological products should have a quality assurance service in order to provide assurance that premises, equipment, personnel, methods and Records in any form describing or registering the methods, organization and / or results of a preclinical (non-clinical) study, factors influencing the study and measures taken, drawn up in the prescribed manner. documentation comply with regulatory requirements.

3.6. The quality assurance service should be independent of the personnel involved in the research, but the staff of this service should be familiar with the procedures for conducting research and report directly to the management of the test center.

4. Principles of Good Laboratory Practice

4.1. Organization and personnel of the test center

4.1.1. Responsibilities of the Test Center Administration

4.1.1.1. The test facility management must ensure that the principles of good laboratory practice are fully observed.

4.1.1.2. In particular, the administration should:

a) approve provisions that identify the person(s) with overall responsibility for managing research in accordance with the principles of good laboratory practice;

b) ensure that sufficient competent personnel, facilities, equipment and materials are available for the timely and proper conduct of the study;

c) ensure the availability of documentation of the qualifications, education, work experience and job responsibilities of specialists and technical personnel;

d) ensure that all employees clearly understand their responsibilities and, where necessary, provide them with appropriate education and training;

e) be responsible for carrying out research activities in accordance with applicable standard operating procedures; approve standard operating procedures and their amendments;

f) be responsible for organizing and implementing the quality assurance program in accordance with the principles of good laboratory practice;

g) designate, prior to the commencement of the study, an individual with appropriate education, qualifications and work experience as the Study Director. The replacement of the Study Director should be carried out in accordance with established procedures and should be documented;

h) designate, as appropriate, for a multi-site study, a responsible investigator who has the appropriate education, qualifications and experience to oversee the conduct of that phase(s) of the investigation. The replacement of the principal investigator must be carried out in accordance with established procedures and must be documented;

i) ensure that the study plan is documented by the Study Director;

j) ensure that the study director provides quality assurance personnel with access to the approved study plan;

k) maintain historical files of all standard operating procedures;

l) designate a person responsible for the management of the archive(s);

m) ensure the implementation of the main schedule;

n) ensure that test facility resources meet the requirements for their use in research;

o) when conducting studies at multiple sites, ensure that there is ongoing communication between the study director, responsible investigators, quality assurance personnel and those performing the study;

p) ensure that test items and reference items are described appropriately;

q) establish procedures to verify that computerized systems are appropriate for solving research problems and are validated, managed and maintained in accordance with the principles of good laboratory practice.

4.1.1.3. When performing any phase of a study at a given test site, the test site administration (if specified in advance) is responsible for all of the above responsibilities except 4.1.1.2 g), i), j) and o).

4.1.2. Responsibilities of the Study Director

4.1.2.1. The Study Director is responsible for the overall management of the study and is responsible for preparing the final report on the results obtained.

4.1.2.2. The responsibilities of the Study Director include, but are not limited to, the following functions.

The Study Director must:

a) approve the study plan and amendments to it, certifying with a dated signature;

b) ensure that quality assurance personnel have copies of the study plan and amendments received in a timely manner and are in constant contact with staff throughout the study;

c) ensure that the study plan and amendments thereto are available to those performing the study;

d) ensure that the study plan and the final report on the results of a study performed at multiple test sites define the role of each responsible person(s) and each of the test centers and test sites involved in the conduct of the study;

e) ensure that when performing work in accordance with the study plan, the impact of any deviations from the study plan on the quality and integrity of the study is assessed and documented and corrective actions are taken, if necessary, and also recognize (or not recognize) the acceptability of deviations from the standard operating procedures;

f) ensure that all primary data are recorded in full;

g) ensure that the computerized systems used in the study are validated;

h) sign and date the final report, thereby accepting responsibility for the accuracy of the information and for performing the study in accordance with the principles of good laboratory practice;

i) ensure that the study plan, final report, primary data and supporting materials are archived after completion of the study.

4.1.3. Responsibilities of the Responsible Investigator

The responsible investigator is responsible for carrying out the research steps assigned to him in accordance with the principles of good laboratory practice.

4.1.4. Responsibilities of Research Personnel

4.1.4.1. All personnel involved in the conduct of a study should be familiar with the principles of good laboratory practice as they relate to the study they are performing.

4.1.4.2. Research personnel should have access to the study plan and the relevant standard operating procedures. It is his responsibility to follow the instructions contained in these documents. Any deviation from these instructions must be recorded; such deviation must be reported directly to the study director and/or the responsible investigator(s).

4.1.4.3. Personnel performing research in accordance with these principles of good laboratory practice are obliged to keep records of primary data in a timely and accurate manner and be responsible for the accuracy of the information provided to them.

4.1.4.4. Examination personnel must take precautions to reduce the risk to their own health and to ensure that the examination is complete. All cases of illness or illness should be reported to management immediately so that the absence of the sick person cannot affect the conduct of the study.

4.2. Quality Assurance Program

4.2.1. General provisions

4.2.1.1. The testing facility should have a documented quality assurance program to ensure that the studies carried out in it comply with the principles of good laboratory practice.

4.2.1.2. The implementation of the quality assurance program is the responsibility of authorized persons appointed by the management of the test facility, reporting directly to him and familiar with the methods of research.

4.2.1.3. Persons responsible for A set of systematic and planned actions to ensure that the conduct of a study is in accordance with good laboratory practice. quality assurance should not be involved in the conduct of the study.

4.2.2. Responsibilities of Quality Assurance Personnel

4.2.2.1. Quality assurance personnel are required to perform, but are not limited to, the following functions. Quality assurance personnel should:

a) have copies of all approved study plans and standard operating procedures in use at the test facility and have access to a current version of the master schedule;

b) verify that the study plan contains the information necessary to comply with the principles of good laboratory practice. This check should be documented;

c) exercise systematic control over the conduct of all studies in accordance with these principles of good laboratory practice and the availability of study plans and standard operating procedures to personnel involved in the conduct of the study.

There are three types of inspections in accordance with the standard operating procedures defined in the quality assurance program:

Checks of individual studies,

Test site inspections

Checks of individual processes.

Protocols (reports) of such inspection checks are not subject to destruction;

d) review final reports; confirm that the methods, procedures, observations and results are set out accurately and completely and fully reflect the primary research data;

e) present the results of inspections in writing in a timely manner to the management of the test facility, the study director, the responsible investigators and, if necessary, other senior officials;

f) include in the final report a prepared and signed conclusion on the types of inspections and the dates of their conduct, with information on the stage (stages) of the study being checked and the date of transmission of the inspection results to the management of the test center, the head of the study and the responsible investigator. This conclusion should also contain information that the primary data of the study are reflected in the final report reliably.

4.3. Premises

4.3.1. General provisions

4.3.1.1. The dimensions, arrangement and location of the premises for conducting research should meet the objectives of the research. The rooms should be arranged in such a way as to have a minimal impact on the course of research.

4.3.1.2. The premises should be planned in such a way as to ensure the most isolated conduct of studies of various types (types).

4.3.2. Research facilities

4.3.2.1. The test facility shall have sufficient rooms and areas to provide isolation of test systems and individual research projects known to involve the use of substances or organisms classified as biologically hazardous.

4.3.2.2. Appropriate facilities and areas should be allocated for the diagnosis, treatment and control of diseases to ensure the stability and safety of the test systems.

4.3.2.3. The test center must have facilities, including storage for resources and equipment. These rooms should be isolated from the rooms or areas containing the test systems in order to provide them with adequate protection from infestation, contamination and/or contamination.

4.3.3. Premises for processing test and standard (control) objects

4.3.3.1. To prevent contamination, the test center should have separate rooms or areas for receiving and storing test and standard (control) objects and mixing test objects with carriers (solvents).

4.3.3.2. Stores for test items should be isolated from rooms or areas containing test systems and should meet the requirements for identity, concentration, purity and stability, as well as the safe storage of hazardous substances.

4.3.4. Premises for archives

Archives should be provided for the safe storage and retrieval of study plans, primary data, final reports and samples. In these premises, conditions must be created to ensure long-term storage of archival materials.

4.3.5. Waste removal

The treatment and disposal of waste must be carried out in such a way as not to jeopardize the conduct of research and not to distort its results. This requires providing appropriate conditions for the collection, storage and disposal of waste, as well as procedures for their decontamination and subsequent transportation.

4.4. Equipment, materials and reagents

4.4.1. Equipment, including validated computer systems used to create, store and retrieve data, as well as to control environmental parameters, should be appropriate in characteristics and location for the goals and objectives of the study.

4.4.2. Provision should be made for periodic maintenance of the equipment used in the study, including regular preventive inspection, care, calibration in accordance with standard operating procedures. These works must be accompanied by appropriate records. Calibration should be carried out in accordance with national or international measurement standards.

4.4.3. The equipment and materials used in the study should not affect the condition of the test systems.

4.4.4. Chemicals, reagents and solutions must be labeled with information about the name of the substance, concentration, expiration date and storage instructions. Information regarding place of manufacture, date of manufacture and stability should be available. The retention period may be extended based on the results of a documented review or analysis.

4.5. Test systems