CONTROL OF BACTERITIC DRUGS — a complex of the actions providing production and production of the effective and safe bacteritic drugs conforming on quality indicators to the established standards.
Bacteritic drugs (see) use in practice of health care for specific prevention and treatment inf. diseases. They are characterized by a number of the essential features caused by the fact that they are trained, as a rule, from pathogenic microorganisms or microorganisms with the weakened pathogenicity or their toxic products. Disturbances of conditions of production, the mode of manufacturing techniques of bacteritic drugs can cause decline in quality of drug and danger both for the working personnel, and for persons, the Crimea is appointed drug. Therefore control of quality is one of the most important and responsible elements of process of production and production of drug.
Essentially the control system accepted in the USSR, and the used methods of assessment of quality indicators of bacteritic drugs are according to WHO recommendations on the basis of which control and in other countries is organized. The general principles of the organization of control reflected in WHO recommendations provide the control of the produced bacteritic drugs which is carried out by production institutions and national control authorities at the modern methodical level.
According to the rules established in the USSR production of bacteritic drugs can be carried out only in the presence of the special technical documentation approved by M3 of the USSR regulating conditions of production, all necessary indicators of quality, the scheme of control of quality indicators of drug at all stages of its production and control methods.
Each enterprise producing bacteritic and virus drugs for practice shall be registered in State Research Institute of standardization and control of medical biological supplies of L. A. Tarasevich M3 of the USSR (GISK of L. A. Tarasevich) to which functions of the state control of quality medical - biol are assigned, the drugs produced in the country. To organize production and production of any drug, production establishment shall send to the specified institute of the data on this production (the scheme of an arrangement of production rooms, the equipment, the scheme tekhnol. flow), about qualifications of personnel, technical documentation, etc. On the basis of the provided information, and in certain cases after special inspection of the opened production, GISK of L. A. Tarasevich grants permission for production of a certain drug in this production establishment. The first three batches of drug before release shall be put on an obligatory trial check test in GISK of L. A. Tarasevich then the serial production of drug is allowed to the enterprise.
To. the bp provides carrying out control a lab. tests at all production phases, since assessment of a feed stock and reactants used in production and finishing qualities of production strains of microorganisms, mediums, semi-finished products finished goods.
The rules existing in the USSR provide the obligatory two-level duplicated control of each series of drug. The first stage of control is carried out in the production laboratory producing drug. Checked on all indicators provided by technical specifications, drug with the corresponding documentation is transferred to additional complete control to the special division existing in each manufacturing enterprise — the department biol, control (DB,C). This department exercises control of quality of the drugs produced by the enterprise according to the accepted technical specifications and behind respect for technology at all fabrication stages of drug according to regulations of production. Ready drugs can be released and sent to the consumer only after control to OB K, execution in accordance with the established procedure of the documents certifying quality of products, and assignment of a series of drug of control number OB K which shall be specified on each ampoule of the produced drug.
In addition to the careful duplicated inspection of each series of drug which is carried out at manufacturing enterprise, GISK of L. A. Tarasevich exercises random inspection of the drugs made by various production institutions. At poor quality of drugs of in-t has the right to take products of this enterprise on preliminary control. It means that GISK of L. A. Tarasevich will control all series of the drug made by the enterprise before release. About BQ has the right of issue of control number for a series of drug only after obtaining the positive conclusion of GISK of L. A. Tarasevich. If the enterprise continues to produce drugs of poor quality, GISK of L. A. Tarasevich is obliged to raise a question before M3 of the USSR of temporary cessation of production of drug at this enterprise before taking a step, necessary for ensuring production of rather high quality.
Carrying out functions of supervision of quality of drugs, GISK of L. A. Tarasevich, in addition to random inspection of samples of the drugs produced by the enterprises systematically inspects the enterprises for the purpose of check of conditions of production, states tekhnol. processes and To. bp. On the basis of results selective To. bp, materials of inspection inspections, and also reporting materials received from OB K of the enterprises, GISK of L. A. Tarasevich activity of the separate enterprises analyzes and makes the corresponding recommendations submitted on upgrading of drugs. Obligatory respect for the organizational principles of control, the general for all drugs, provides at the same time essential distinction of methodical approaches to control of separate types of drugs taking into account their features and specifics of production. The qualities, general and obligatory for all drugs — safety for people and sufficient specific activity. Assessment of a drug safety in a lab. conditions aims at identification of possible presence at drugs first of all of the toxic substances connected with the nature of starting bacterial material (the toxic components of microbic cells which got to drug owing to disturbance of manufacturing techniques, insufficiently neutralized toxins at production of anatoxins etc.). On the other hand, check of safety provides identification of possible kontaminiruyushchy agents who could get to drug from the outside owing to disturbances tekhnol. process (bacterial pollution, various toxic products from not enough processed production tanks).
Check of a drug safety carry out a lab by their introduction. an animal with the subsequent overseeing by them for the purpose of identification of the general and local reactions connected with existence in controlled drug of undesirable impurities. Choice lab. doses of drug, animal and necessary for introduction, it is carried out taking into account features of each drug. Most widely for this purpose use white mice, Guinea pigs and rabbits.
For identification of possible bacterial pollution of bacteritic drugs carry out by foreign microflora check tests on sterility by crops of drug on special mediums. Crops of drugs on such environments allow to reveal the minimum quantities of microorganisms of different types which can kontaminirovat drug. It is in certain cases important to exclude existence in drug of the initial pathogenic microorganisms used for production of drugs; in these cases carry out crops of drugs on the selection environments providing growth of certain species of microorganisms.
Lab. control of specific activity of bacteritic drugs is connected with certain difficulties as these drugs represent difficult biol, substances of the proteinaceous nature. Specific activity of bacteritic drugs cannot be measured chemical or physical. by methods as it is accepted at assessment pharm, drugs therefore for its assessment use biol, methods. The most reliable lab. method of definition of specific activity of drugs is detection of their protective properties in animal experiments. For the quantitative characteristic of activity of drugs use the methods based on use of standard drugs with precisely established activity, with to-rymi activity of the used drugs is compared. In system of WHO and in the certain countries services biol, the standardization providing production institutions with the uniform precisely calibrated standards of activity are created. For some drugs as auxiliary methods of definition of activity use various immunol, reactions by which it is possible to define concentration of antigens or antibodies in the studied drugs. For live vaccines as an indicator of full value of drug on specific activity the quantity can serve in it live microorganisms.
In addition to the main criteria of quality, safety and specific activity, bacteritic drugs are characterized also nearby important quality indicators which number treat: content in drug of protein, nitrogen, aluminum hydroxide, mertiolyat, phenol, formalin, alcohol, residual humidity of drug, indicators of pH, fractional composition of proteins, etc. For each drug taking into account its features optimum or marginal standards of the contents of the specified substances are established. To. the bp on these indicators is carried out by means of the standard or modified methods used in chemistry.
The system of production and control of bacteritic and virus drugs accepted in the USSR provides production of the qualitative drugs answering to the modern level of development of science. The existing system of the state control of quality of drugs provides also constant improvement of drugs taking into account the experience accumulated in the country and abroad and also taking into account WHO recommendations.
Bibliography: The methodical guide to laboratory evaluation test of bacteritic and virus drugs, under the editorship of S. G. Dzagurov, etc., M., 1972; The Guide to vaccinal and serumal business, under the editorship of P. N. Burgasov, M., 1978; The Reference book on use of bacteritic and virus drugs, under the editorship of S. G. Dzagurov and F. F. Rezepov, M., 1975; Standards, strains and control methods of bacteritic and virus drugs, under the editorship of S. G. Dzagurov, etc., century 2, M., 1976.
F. F. Rezepov.