STANDARDIZATION (English standart norm, a sample, a criterion) — process of establishment and use of standards, i.e. sets of the normative and technical documents regulating a complex of norms, rules, the requirements to object of standardization approved by competent authority. The page is carried out in the relation as material objects (industrial and agricultural output, standards, samples of substances), not material (norms, rules and requirements of different function). An object C. are also various forms of services, methods and means of ensuring of unity and accuracy of measurement, terminology, standard forms of documents, symbols, environmental control and rational environmental management etc. Special incidence of S. is the medicine, in a cut as objects C. - serve pharmaceuticals, other products of medical appointment, safety of work (see below).
So-called standard samples, i.e. the substances having rather precisely known and officially certified values specific to this substance properties (parameters) can serve as a characteristic example from area C. According to the destination they belong to the class of metrological means (see. Metrology ). They are made on special technology, and values of properties (parameters) are established by results of the researches conducted but the set program.
Standard samples are widely used at production and processing of mineral raw materials, at the control of raw materials and materials delivered within the international economic cooperation in health care (for unification of kliniko-biochemical analyses), in the field of environmental control (observation and control of environmental pollution) etc.
In the USSR standardization is one of elements of the state technical policy which are closely connected with system of planning and management of the national economy. As the main objective of S. at the same time serves establishment of uniform requirements to technological level and quality of products, a feed stock, materials, components, and also rationing of requirements and methods at design and production of this or that appointment. Use of standards in ^ the state scale promotes improvement of quality of products, provides increase in level of unification and interchangeability, creates the best opportunities for automation of these or those productions, improvements of working conditions.
The state system of standards of the USSR combines work on S. at all levels of management of the national economy. It represents the complex of rules and provisions combining the purposes and S.'s problems; organization and technique of carrying out S.; order of development, implementation and circulation of normative documents, and also introduction of changes in them; order of the state supervision and departmental control of their implementation and observance; objects C., categories and types of standards etc. Planning of all actions in the area C. is a component of the state system of planning.
The decree of SNK RSFSR (1918) «About introduction of the international metric system of measures and scales» became the document, the first in the history of the Soviet power, in the area C. The first all-union standard was entered into the USSR in 1926: OST-1 «Pshchenitsa. Selection grades of grains. Nomenclature». In the next years the numerous standards covering practically all industries and agriculture of the Soviet Union were developed and approved. For their 1978 there was already St. 20 thousand.
Idiosyncrasy of S. in our country is transition from separate S. to development and deployment of cross-industry systems of standards of nation-wide value. Treat them: The State System of Standardization (SSS), the State measuring system (GSP), the Uniform System of Design Documentation (USDD), the Uniform System of Technological Documentation (USTD), the Uniform System of Technological Preparation of Production (USTPP), the Uniform Occupational Safety Standards System (UOSSS), System of standards on environmental control etc. Are developed also the comprehensive program of S. on the most important types of products. Uniform requirements to technological level and quality of products, components, raw materials, materials and the equipment, to control facilities, measurements and tests of products etc. are provided in them.
The general management of S. in scales of all country since 1954 is performed by the State committee of the USSR on standards (Gosstandart), and in the field of pharmaceuticals, vaccines and serums — M3 of the USSR. The system of bodies and services of Gosstandart of the USSR includes republican managements, the centers for S. and metrology, research institutes, laboratories of the state supervision of observance of standards. The St. 600 parent, basic organizations of various industries of the national economy of the USSR carry out these or those types of the works connected with standardization.
The right of standardization, in addition to Gosstandart of the USSR, in the field of medicine and health care also the M3 of the USSR has. Management on implementation of new pharmaceuticals and USSR M3 medical equipment carries out S. concerning pharmaceuticals, medical equipment, the pharmaceutical equipment, medical biological and immunobiological supplies, and also some other the actions directed to preservation of health of the person.
Standards depending on an order of the statement, and also scope of application have several categories: state standards (GOST), industry (OST), republican (RUTI), standards of the enterprises (associations) — STP.
State standards (State standard specifications) are approved by the State committee of the USSR on standards (Gosstandart), except for nek-ry types of the standards approved by Council of ministers of the USSR, the State committee of the USSR on construction (State Committee for Construction) and M3 of the USSR.
State standard specifications are obligatory for all ministries, the state committees, departments of the USSR, for all state, cooperative and other public organizations.
Industry standards (OST) are approved by the all-union and allied and republican ministries, the State Committees and departments of the USSR. They are obligatory for all enterprises, the organizations and institutions of the department which approved the corresponding standard. OST on products are approved by the ministries or departments, to-rye are head at design or production of this type of products, and are obligatory for other ministries (departments), the enterprises, the organizations and institutions connected with production, development, transportation, storage, operation of the corresponding type of products.
Republican standards (RUTI) are approved by republican councils of ministers of federal republics (or, on their assignment, State Planning Committees or state systems of federal republics). Are obligatory for RUTI for all enterprises, the organizations, institutions located in the territory of the federal republic, irrespective of departmental subordination.
Standards of the enterprises or associations (STP) are obligatory only for the enterprise (association), the organization and the institution which approved this type of the standard.
On the basis of the corresponding standards the technical specifications (TS), i.e. the normativnotekhnichesky document (specifications and technical documentation) establishing a complex of requirements to a specific type of products are developed.
In the course of S. standards are developed, claimed and change special public authorities in the order provided by the State system of standardization. For each standard terms of commissioning, and scope of application — category of the standard are provided (i.e. nation-wide, industry, republican etc.).
Idiosyncrasy of S. is its technical and legal competency. It is peculiar for S. concerning products, technological processes, environmental control, safety of work etc. Execution and control of observance of standards is provided with the relevant standards of the law in force, the legal responsibility for violation of the standard is provided in Krom.
In the field of health care there is the whole system of acts (see. Sanitary legislation), edges are provided by observance of implementation of the standards directed to preservation of health of the Soviet person (see Occupational health, Standards hygienic, Environmental control, Labor protection, etc. similar articles).
Idiosyncrasy of the present stage of development of S. in the USSR is S. Eto's complexity is shown that at enforcement of these or those standards coherence of indicators of the interconnected standards and terms of their introduction to action is provided. S.'s complexity is provided with the development of programs C. combining products, semi-finished products • and materials, technical means, the organization of production etc. S.'s complexity allows to use more effectively possibilities of modern production, to carry out cross-industry coordination, to meet requirements of interested parties.
Standardization within SEV will be coordinated with tasks of the Comprehensive program of further deepening and improvement of cooperation and development of socialist economic integration of member countries of the Council of Economic Mutual Assistance (CEMA). The Constant commission on S., the industry constant commissions, institute of SEV on S. and S.'s department of the secretariat of SEV deal with issues C. in SEV. The main directions of works — creation of systems of normativnotekhnichesky documents (system of the specifications and technical documentation of SEV according to S.; the automated management information system C. and metrology of SEV; uniform system of design documentation of SEV; uniform system of admissions and landings of SEV), and also complex standards on products which are a subject of barter between member countries of SEV. Norms and requirements of the SEV standards conform to the international standards. By January 1, 1975 4900 recommendations of SEV about S. and 120 SEV standards are accepted. 28th Session of SEV (on June 21, 1974) approved «The provision on the SEV standard (ST of SEV)» and approved the Convention on direct (direct) use of the SEV standards. The convention on use of ST of SEV is ratified by Presidium of the Supreme Council of the USSR the decree of September 17, 1974. Development and use of the SEV standards exert decisive impact on an intensification of processes of socialist economic integration, improvement of the international socialist division of labor, increase in level of production and quality of products, on strengthening of competitiveness of products of the socialist countries in the world markets and give considerable economic effect. Use of the SEV standards in the national economy of member countries of SEV causes further rapprochement of national systems C.
The international standardization is connected with development of multilateral scientific and technical and economic cooperation. Questions C., metrology, upgrading of products, except the national organizations, is engaged more than 300 international and regional organizations (1975). The largest international organizations work in the area C.: Economic Commission for Europe of the UN (UNECE), International Organization for Standardization (ISO), International Electrotechnical Commission (IEC).
The international standards and recommendations developed by these organizations establish the indicators conforming to modern scientific and technical requirements to quality, reliability, safety and other major properties and characteristics of different types of products which are a subject of international trade and also define the unified methods and means of tests and certification of materials and goods. Use of the international standards promotes expansion of scientific and technical, economic and commercial relations. The international standards are widely used during the development of national standards that allows to reduce considerably terms and cost of their development and to gain big economic effect.
Standardization in medicine
Standardization in medicine are a development and use of uniform norms, rules, requirements at research and implementation of medicinal, immune and other medical, preventive and diagnostic means, and also medical equipment. The page promotes streamlining of the specified processes taking into account requests and with the assistance of all interested parties. Page provoditeya taking into account achievements of science, the equipment, the best practices of medical, sanitary and epidemiologic, research, pharmaceutical and other medical institutions, and also the enterprises medical and other industries making products for the lechebnodiagnostichesky and preventive purposes. S.'s results find reflection in normative and technical documents — the standards obligatory for use, and nek-ry others similar appointment documents (norms, methods of their control, instructions, medikotekhnichesky requirements, rules, normative materials, methodical recommendations and instructions) developed in accordance with the established procedure and approved by the relevant managements M3 of the USSR.
Technical specifications — the normative and technical documents (NTD) establishing a complex of requirements to specific types, brands, articles of products. Technical specifications are an integral part of a complex of technical documentation on products, on to-ruyu they extend. The technical specifications containing the requirements connected with safety of work and health protection of workers and employees are subject to approval of bodies of health care in the order established to M3 of the USSR.
Medico-performance specification (requirement specifications) are developed on the basis of studying and the analysis of achievements of the domestic and foreign equipment, advanced technology of production, results of performance of researches, and also on the basis of requirements of the customer — M3 of the USSR.
Medico-performance specification (requirement specifications on products of medical equipment and other products of medical prescription) are approved by Management on implementation of new pharmaceuticals and USSR M3 medical equipment and that instance, the cut submits the organization of the developer.
The page is applied in medicine to pharmaceuticals (see. Pharmacopoeia , Register state , Control of pharmaceuticals ), the pharmaceutical equipment (see. Drugstore ), medical products and products of medical equipment, as that: tools, devices, devices, conditioning agents for patients, the medical equipment etc. (see. Medical equipment ), medical biological and immunobiological drugs (see. Bacterial standard , Control of bacteritic drugs ), food stuffs (see. Food ), special types of clothes (see. Clothes special ), individual means of protection (see). Except physical items, S. covers in medicine all system of the norms ordering in the form of rules, recommendatory (methodical) letters, requirements etc., an order of use of methods and prophylactics, diagnoses and treatments, holding specific treatment-and-prophylactic, sanitary and hygienic and organizational actions, clinical tests, laboratory researches. Here the normative requirements to working conditions ordered by health regulations belong (see. Occupational health , Labor protection , Maximum allowable concentrations , Accident prevention , Work , Ergonomics ) and to norms of the work connected with radiation or toxic hazard (see. Radioactive materials , Physics health , Radiation safety , Toxicology ), to a condition of air in household, sports and other rooms, to quality of water, purity of the soil, to the sizes and quality of living space (see. Utility hygiene ), to emissions of the industrial enterprises (see. Environmental control ) and all other norms, essential important for public health care, and also requirements to respect for these norms (see. Standards hygienic , Sanitary inspection , Sanitary legislation , Sanitary and epidemiologic station , Sanitary inspection ). A specific place is held by standardization of methods of measurements, the measuring equipment and the applied units of measurements (see. Units , International System of Units , Metrological health service , Metrology , Measuring instruments of medical prescription ). The page extends also to medical documentation (see. Documentation medical ) and medical terminology (see. Terminology medical ).
Scheduling on standardization in the field of medicine belongs in the main M3 of the USSR. All work on S. in the USSR M3 system is assigned to Management on implementation of new pharmaceuticals and USSR M3 medical equipment. Besides, the corresponding specialists of Head departments and managements M3 of the USSR take part in work on S.: sanitary and epidemiologic, pharmaceutical, the treatment-and-prophylactic help, the treatment-and-prophylactic help to children and mothers, quarantine infections, on production of bacteritic and virus drugs, the State inspectorate for control of quality of pharmaceuticals and products of medical equipment.
Prepare the specifications and technical documentation on standardization and standards, serve standardization in the USSR M3 system head (STATE) and basic it (is BAREFOOT) the standardization organizations, research institutes which are carrying out tasks of standardization, and departments of standardization and metrology of sanitary and epidemiologic stations, the parent and basic organizations of metrological health service (see. Metrological health service ).
It agrees to the legislation on health care (see) The Ministry of Health of the USSR approves, besides, the following normative documents existing as standards: all-union sanitary and hygienic and sanitary and anti-epidemic rules and norms, and also methods of their control; medico-performance specification; instructions, methodical instructions, rules for implementation of the state sanitary inspection, ensuring sanitary and epidemic wellbeing and radiation safety; according to the prevention of infectious and occupational diseases; diagnostic methods, treatments and prevention, and also on carrying out clinical tests of the new equipment and pharmaceuticals, vaccines and serums; on protection of motherhood and the childhood; to examination of working capacity, medicolegal and forensic-psychiatric examination; on sanatorium treatment, and also the instruction and normative materials in the field of the statistical account and the reporting.
Management on implementation of new pharmaceuticals and USSR M3 medical equipment conducts and publishes the State register of pharmaceuticals, all-in the pharmaceuticals allowed for use in the USSR, and the State register of medical products containing the medical products allowed for use in the USSR.
Standardization of pharmaceuticals
the Management and control in the area C. of pharmaceuticals belongs to Management on implementation of new pharmaceuticals and USSR M3 medical equipment. The main objective of Pharmacopoeian committee of this management is consideration of drafts of the specifications and technical documentation defining requirements to quality of pharmaceuticals and medicinal raw materials, and also methods of their control. The state inspectorate for control of quality of pharmaceuticals and products of medical equipment controls observance by the enterprises and organizations of all ministries and departments of the USSR of the State and industry standards, pharmacopoeian articles, iroizvodstvenny regulations, the technologist. instructions, etc. documents, including requirements to packaging, marking, external design and providing a trade dress of the medicines produced by them. The state inspectorate draws the conclusions according to plans of standardization, projects of the state and industry standards and pharmacopoeian articles for pharmaceuticals.
Pharmacopoeian articles are approved by Management on implementation of new pharmaceuticals and USSR M3 medical equipment on the medicines and medicinal vegetable raw materials of serial production allowed by the order for medical use. Vreme.nny pharmacopoeian articles on medicines and medicinal vegetable raw materials are approved by the specified management on the first industrial (adjusting) series of the new pharmaceuticals recommended for medical use Pharmacological committee (see) and planned to serial production. They are approved for the limited term established depending on extent of working off of drug under production conditions, but no more than 3 years.
All pharmacopoeian articles contain the standardized methods of definition of indicators of quality of pharmaceuticals obligatory for control and analytical laboratories, the enterprises - will produce-pour also pharmacy chain.
Methods of standardization of pharmaceuticals. For establishment of authenticity and purity of substances, and also for definition of the normalized concentration of substances in solutions on physical quantities the unified physical are used. - chemical methods of the analysis using tools of the established accuracy of measurements (see. Control of pharmaceuticals ). To such physical. - to chemical methods of the analysis of pharmaceuticals belong: refractometry (for determination of indices of refraction), a polarimetry (for determination of size and sign of rotation of the plane of polarization), a spektrofotometriya in infrared, ultra-violet and visible spectral ranges (for definition of absorption indexes of light) and other methods. For identification, definitions of purity, and also are applied to quantification of substances and mixes standard hromatografichesky methods of the analysis: ion-exchange chromatography, a partition chromatography on paper, a thin-layer chromatography, etc.
However it is only impossible to judge quality of a number of pharmaceuticals on the basis of chemical and physical. - chemical researches. Such drugs in addition subject to biological assessment. Treat the pharmaceuticals subjected to biological assessment: cardiac glycosides and their galenova drugs, structure to-rykh it is changeable; organopreparata and nek-ry hormonal drugs, chemical structure to-rykh it is found insufficiently out; antibiotics, a way of receiving to-rykh does not provide constancy of activity, etc.
Biological assessment, or biological testing, aims at establishment in an experiment on animals of amount of active ingredient in medicine by determination of force of its specific action. For this purpose use biological valorization and biological standardization. Biological valorization is a definition of number of the biological units of action (UA) in this amount of drug. Understand establishment of the dose of the examinee of drug causing effect of a certain intensity as biological standardization. This dose is accepted to biological unit of action. Determine by method of recalculation the maintenance of biological units of action in 1 g (1 ml) of drug (valorization).
In the USSR activity of the majority of the pharmaceuticals subjected to biological standardization is expressed in terms of action (PIECE). The required number of PIECE for each medicine is specified in the relevant pharmacopoeian article.
Many methods physical. - the chemical analysis and biological standardization of pharmaceuticals are connected with comparative assessment of the examinee of drug in relation to substances, the chemical structure or activity to-rykh differ in constancy and can be established with a necessary accuracy. Such substances call on the State pharmacopeia of the USSR GFH standard samples or standards. Standard samples are applied at such methods of the analysis as photocolorimetry (see. Colorimetry ), spectrometry (see. Spektrofotometriya ), flyuorimetriya (see), polyarografiya (see), chromatography (see). The method of comparison with standards and standard samples estimates chromaticity of solutions of the studied drugs, their purity, concentration of substances in solution etc. Besides, standard samples are necessary for assessment of activity of antibiotics, hormonal drugs, cardiac glycosides and other biologically active drugs.
Standard samples can be chemical and biological. Chemical standard samples represent the individual high cleaning substances having exact physical. - chemical characteristics (ranges in infrared and ultra-violet areas, ranges of kernels-but-magnetic resonance, indicators of hromatografichesky mobility etc.). Biological standard samples most often are complex mixtures of substances. They are less homogeneous on the structure in comparison with group of chemical standard samples. Heterogeneous substances of a natural origin (e.g., standard samples of a lily of the valley, a foxglove, powder of a back share of a hypophysis), the cleared connections from natural sources (e.g., biological standard samples of antibiotics, individual hormones, glycosides etc.) or the synthetic connections having rather high degree of purity (e.g., Angiotensinamidum — the standard) can be them. They are used for definition of biological activity and testing of pharmaceuticals for authenticity and applied in that case when as the main or additional control method of medicine serves definition of activity of drug by means of animal testing, the isolated bodies or microorganisms.
In the USSR standard samples are developed by specialized in-ta together with the enterprise - mi - manufacturers according to plans of standardization of M3 of the USSR. Pharmacopoeian articles on them are approved by Management on implementation of new pharmaceuticals and USSR M3 medical equipment. Certification, storage and distribution of standard samples are carried out by State Research Institute on standardization and control of M3 medicines of the USSR.
The international system of standardization of pharmaceuticals
prepares WHO and publishes the International Pharmacopoeia representing the collection of specifications of quality of limited amount of medicines with the description of appropriately picked up standard methods of the analysis allowing to estimate quality of pharmaceuticals.
WHO develops and dispatches also international standard samples (chemical and biological). - The international chemical standard samples are developed by the International help center WHO for chemical standard samples in Stockholm. The International laboratory of standardization of biological drugs of National institute of standardization and control of biological drugs in London is engaged in development and release of the international biological standards. WHO carries out also work in the field of standardization (unification) of the terminology connected with pharmaceuticals, identifications of their names, etc. (see. Terminology medical ). The international Pharmacopoeia and other developments of WHO in this area bear advisory nature.
Successful expansion of the international cooperation of the socialist countries in standardization of control methods of efficiency and safety of new pharmaceuticals, and also control of their quality demanded joint development of methodical instructions by member countries of SEV concerning experimental and clinical tests of pharmaceuticals. There was also a need of development of the general standards of their quality. For this purpose in the working group of pharmaceutical industry of the Constant Commission on chemical industry of SEV the special body — the Meeting of specialists in standardization of pharmaceuticals was created.
The program providing development of the general methods physical is carried out. - chemical, chemical and biol. tests for control of pharmaceuticals, and also the general rules for designation of finished pharmaceutical products.
Within the chemical commission of SEV the Compendium Medikamentorum» was developed «, in to-ry control methods of pharmaceuticals and the requirement to separate medicinal substances and drugs consistently joined. Actually «the Compendium Medikamentorum» was the collection of standard requirements to pharmaceuticals.
After the organization of the Commission on health care within SEV and considering that according to the legislation of the USSR and other socialist countries questions of development, the approval of standards on pharmaceuticals in the form of pharmacopoeian articles are carried to competence of bodies of health care, the section of development «the Compendium Me-dikamentorum» was transferred to the Commission on health care and included in a framework of the II Problem «A research, assessment and standardization of pharmaceuticals». «The compendium of Medi-kamentorum» has advisory nature and on the current situation «the Compendium Medikamentorum» member countries of SEV use requirements when the parties do not find it possible to agree about supply of the corresponding medicines according to requirements of the corresponding national pharmacopeias. Besides, by drawing up national pharmacopeias it is recommended to use the requirements put in «the Compendium Medikamentorum» to pull together national pharmacopeias with his requirements. The question of a possibility of recognition «the Compendium Medikamentorum» is considered by a pharmacopeia of SEV.
The same character standardization is carried out to areas of vaccines and serums, and also in the field of medical equipment; the SEV international Terminological dictionary containing definitions of the basic concepts in the area a wedge, pharmacology relating to pharmaceuticals is developed and approved.
Standardization of products of medical equipment
Standardization extends to all major types of products of medical equipment of serial production which are widely used in medical practice, for example medical ultrasonic therapeutic devices, high-frequency and low-frequency therapeutic apparatuses, electrocardiographs, devices and devices with fiber light guides, devices for an inhalation anesthesia and artificial ventilation of the lungs, surgical tools, etc.
Treat the major all-engineering standards: GOST 20790-82 «Devices, devices and equipment medical. General technical specifications», GOST 12.2.025-76 «SSBT. Products of medical equipment. Electrical safety. General performance specification and test methods», GOST 23256-78 «Products of medical equipment. Requirements to reliability and test methods»; GOST 19126-79 «Tools medical metal. General technical specifications». These standards of a normirovana the general requirements to the main technical and economic indicators, including to design, reliability, electrical safety, and also requirements to storage conditions, transportation and operation of products in various climatic conditions. Some technical and economic indicators, such as reliability in different external environment, are standardized for the first time for these products. On the basis of fundamental standards planned development of normative documents of more low level, number is developed to-rykh exceeded nowadays 2500; among them more than 60 state and 300 industry standards, 2000 technical specifications.
The tendency to sistemnokompleksny approach was outlined in hardware of medical and preventive healthcare institutions by use of a method of aggregation on the basis of block and modular creation of products, use of parametrical ranks and preferential use of uniform elementary base. Modular complexes of medical prescription, the medical automated systems are supposed to be created of the products of medical equipment constructed on the standard unified blocks and modules providing information, constructive metrological and operational compatibility. The new principles of creation of medical equipment will entail change of methods a camp-dartizatsionnogo of providing the developed and made products.
By 1990 it is planned to complete development of the system of standards on medical equipment (SSMT), edges will include the standards establishing the uniform interconnected norms of designing, the requirement to indicators of quality and technological level of products (medical complexes and independent devices, devices, the equipment and tools) at all stages of its life cycle: in the course of development, in production and operation.
Control of quality of products of medical prescription is exercised in three types: state supervision, industry and factory control. The state supervision on control of quality of products belongs to the State committee of standards and the State inspectorate for control of quality of pharmaceuticals and products of medical equipment of the Ministry of Health of the USSR. Industry control is carried out by the relevant Main inspectorates for quality of products together with industry and basic standardization organizations and metrology. Factory control is exercised by the inspection departments (ID) of the enterprises.
Standardization of medical immunobiological supplies
Problems of standardization of immunobiological drugs consist in respect for the established norms and requirements by production of drugs and ensuring strict compliance to their main standards.
Improvement of standards on vaccines (see) and anatoxins (see), immune serums (see), bacteriophages (see), diagnosticums (see) and mediums (see) for cultivation of microorganisms provides increase immunizing them, to lay down. and diagnostic efficiency at simultaneous reduction of side (negative) effect, assumes increase in technological level and profitability of production of drugs. Creation and use of standards allows not only to define and measure quantitative characteristics of quality of immunobiological drugs, but also to bring them to the level of the standard sample received on the basis of the last achievements of science and technology. These problems by means of a set of physical, chemical, physical and chemical, experimental and biological, immunological, epidemiological, clinical, laboratory and tool and statistical methods are solved. At standardization of a new vaccine its chemical composition, structure, harmlessness and an immunogenicity for experimental animals, and then — safety and efficiency for the person is studied in the beginning.
The World Health Organization deals with the international S.'s issues of medical immunobiological drugs. In our country S. of such drugs the Ministry of Health of the USSR knows. The basic establishment performing functions of scientific center concerning standardization of immunobiological drugs, and also duties of the state supervision of implementation and observance of standards on this type of products the State institute of standardization and control of medical biological supplies of the name JI is. A. Tarasevich. It conducts work on creation of standards (standard samples) of immunobiological drugs, reference strains of bacteria for production and control of drugs, and also standardizes techniques of a biological research of separate properties of drugs and check of their compliance to the international requirements.
During the testing of immunobiological drugs it is necessary to apply uniform methods and systems of tests. Reliability of methods of standardization and control of drugs shall be checked periodically by interbench tests. To observe unity in evaluation test of drugs, it is necessary to use the standardized terms and concepts, quality indicators for the same drugs, to be guided by requirements to technical characteristics of the test equipment and to the accuracy of gages. Methods of assessment of quantitative values of indicators, level of quality, testing methods and control, economic evaluation test are obligatory.
Methods C. of immunobiological drugs differ in considerable labor input, their accuracy is limited, reproducibility is difficult. Rate of divergence of results depends on variability of properties of drugs, frequent existence in their structure labile and not enough studied substances (proteins, complex polysaccharides, lipopolisakharida, etc.), and also on the laboratory animals and cultures of fabrics used at tests. Are known, but seasonal changes of activity of bacteria, viruses, fabric cultures, and also dependence of result of experience on a look or the line of laboratory animals are still insufficiently studied; in addition to «sensitive» and «resistant» lines of the same species of animals, connection in development of resistance to toxins or microorganisms at the same line of mice, rabbits, rats is established with conditions of their contents and a diet that testifies to variability of various organisms in natural and simulated conditions.
For this reason the choice of a method and model for definition of specific activity and other properties of immunobiological drugs and correlation of results of a laboratory research with results of studying of effect of drug on people represents extremely difficult task. It concerns many as inactivated, and live vaccines (pertussoid, typroid, cholera, meningococcal, staphylococcal, plague, anthracic, brucellous, etc.). Usually at evaluation test of drugs the main properties which are taken into account are specific activity, specific safety, the general toxicity, identity, lack of contaminants, number of viable cells or virions, reactogenicity, antigenicity and an immunogenicity, stability and others.
Because introduction to the person of immunobiological drugs creates some risk of development of complications, searches of new and more perfect laboratory tests for more total characteristic of drugs, napr, tests gista, activities, a leukocytosis - the stimulating activity, etc. are conducted. Also creation of more perfect methods of assessment and comparison with the standard of physical and chemical properties of drug, napr, on structure of protein fractions of immunoglobulins, antitoxins, anatoxins, etc. is necessary.
For the majority of drugs also the maximum limits of activity are still established only minimum, and for some. Often these limits formulate as «not less than» or «no more than», without giving, however, specific borders «completely» for activity units. Concerning a number of drugs of such assessment can constitute a certain danger. So, existence of the lower limit of an immunogenicity of a pertussoid vaccine offered WHO — 4 ME — in the absence of an upper limit and production on this basis of drug of higher activity can increase probability of its side effect.
Not to put at risk human health, in a process of manufacture of drugs and during the check of finished goods biological monitoring departments of immunobiological drugs exercise a close check on existence of contaminants (sterility, lack of harmful impurity), on toxicity, harmlessness, etc. The drugs which did not undergo control in any parameter are rejected and are not allowed to the use.
Standardization of working conditions
Obligatory all-union sanitary and hygienic and sanitary and anti-epidemic rules and norms, and also the methods of their control for performance by public authorities, institutions and organizations, officials and citizens developed and approved by the Ministry of Health of the USSR are the cornerstone of set of the state, industry, republican standards and standards of the enterprises containing requirements, norms and rules aimed at providing the safe and harmless working conditions, at preservation of health and high performance of the person in the course of professional activity making the uniform interdepartmental nation-wide system of normative documentation called by the occupational safety standards system (OSSS). The SSBT standards are based on the existing rules and rules approved by bodies of the state supervision, including sanitary (see. Sanitary inspection), do not exclude action of other documents regulating working conditions in the industry. Norms, rules, requirements and standards for safety of work shall be mutually coordinated that is controlled by institutions and bodies of the Ministry of Health of the USSR during conducting hygienic examination and approval of documents.
Development of SSBT is begun in the USSR in 1972. Gosstandart and the All-Union Central Council of Trade Unions with the participation of subordinated to them and the Ministry of Health of the USSR of scientific institutions and other departments.
SSBT includes a number of subsystems. Standards of a subsystem About — the fundamental standards establishing structure of SSBT, purpose, task, the field of distribution and feature of approval of the SSBT standards; terminology in the field of labor protection; classification of the dangerous and harmful production factors, general provisions of the organization of training working to safety rules of work. Standards of a subsystem 1 — norms and requirements for types of dangerous and harmful production factors — contain the characteristic of dangerous and harmful production factors (a look, the nature of action, possible effects), marginal levels or concentration of these factors, methods of their control and protection working from their action. Safety requirements to a design of the production equipment and its separate elements (working bodies, an operating controls, control facilities, the alarm system, protection devices, etc.), ergonomic norms and requirements, control methods of their performance are reflected in standards of a subsystem 2. Standards of a subsystem 3 establish safety requirements to productions, placement of the equipment and the organization of jobs, to starting materials, storage and transportation of starting materials, to finished goods and methods of production, to professional selection, an examination working, to use of means of protection working; control methods of implementation of safety requirements. Requirements to constructive, operational, protective and hygienic properties of the means of protection working methods of their tests and assessment are provided in standards of a subsystem 4. In standards of a subsystem 5 the general requirements to buildings and constructions regarding safety of the people working in them, and also safety requirements are given at their construction and reconstruction. Standards of all subsystems contain also control methods of implementation of the established requirements.
The number of the state and industry standards of SSBT comes nearer to 600. Requirements of these standards find reflection in engineering standards and conditions on certain types of the production equipment, materials, substances and productions for what include the section «Safety requirements» in the specified normative documents; about 60 thousand standards containing such section are already enacted.
The program of the state standardization in the field of safety of work for 1981 — 1985 provided development and review of a number of the existing SSBT standards with completion of system development in general in 1985. Specific participation of medical scientific research institute and departments of a hygienic profile in development of such standards as «SSBT is defined. Microclimate of production rooms. General sanitary and hygienic requirements», «SSBT. Air of a working zone. Methods of definition of aerosols of fibrogenny action», and also the standards establishing a gigabyte. requirements to metallurgical production, technological processes of welding, belonging to the agricultural production, cars and mechanisms used during the development of mining fields, etc.
The order of the Minister of Health of the USSR No. 990 of October 19, 1978 entered system a gigabyte. examinations of the SSBT standards, industry standards of safety of work and technical specifications on industrial output from the point of view of its harmlessness at operation. Examination and approval of drafts of such documents is function of republican bodies of health care, examination of GOST SSBT is carried out in scientific research institute of occupational health and occupational diseases of the USSR Academy of Medical Sciences with the subsequent approval of M3 of the USSR. The system of examination allows to reveal shortcomings of drafts of standards and to timely eliminate them.
On the basis of the SSBT standards development of the international system of standards on labor protection within SEV is carried out. At the same time results of domestic scientific works in the field of occupational health are widely used (see) and Soviet gigabyte. standards (see Standards hygienic) that allows to unify a gigabyte. requirements in the national economy of the countries of socialism are also provided by a possibility of comparative estimates of results of scientific research and sanitary practice.
In 1977 — 1979. The constant Commission of SEV on cooperation in standardization approved six fundamental standards of this system which head developers were Soviet organizations. These standards establish the purposes, tasks, the fields of distribution, structure of system of standards on labor protection, terminology in the field of labor protection, classification of dangerous and harmful production factors, the general safety requirements to the equipment and productions, the general requirements to means of protection working and classification of these means. In total from 1976 to 1980 160 SEV standards of this appointment are developed; work is continued according to long-term programs.
Along with it standardization of national standards of the socialist countries on safety of work on a bilateral basis is carried out (the USSR with GDR, NRB, etc.). The standardization of hygienic requirements to industrial equipment based on the SEV standards gains special importance by mutual deliveries in the conditions of socialist economic integration.
Use of the SSBT standards and implementation of sanitary inspection significantly promotes improvement of working conditions on economic objects.
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E. A. Babayan, M. Ya. Kaabak, V. Ya. Maximov; S. G. Dzagurov, A. A. Sumarokov (of), Yu. F. Krylov, V. D. Kucherenko (pharm.), L. A. Potanina, L. A. Serebryany (gigabyte.).