Law O. medicinesah B. Russian Federation installed
priority state control:
Production; - manufacturing; - qualities; - effectiveness; - Drug safety.
State regulation Relations in the field of drug circulation is carried out by:
State registration medicines;
Licensing of drug circulation activities;
Certification and certification of specialists;
State control of production, manufacturing, quality, efficiency, drug safety;
State regulation of drug prices. To implement state regulation of relations
in the field of drug circulation, there is a state quality control system, efficiency, drug safety, which includes:
Federal organ executive and executive authorities of the constituent entities of the Russian Federation;
Research institutions, institutes, laboratories;
Ethical advice in force with health institutions;
- expert advice on the treatment of medicines under the Government of the Russian Federation;
Information system.
State quality control of medicines is defined in the order Ministry of Health of the Russian Federation dated 04.04.2003 No. 137 "On approval of the procedure for exercising a state control of the quality of medicines in the Russian Federation". This document determines the procedure for conducting state control of the quality of medicines in the Russian Federation (with the exception of radiopharmaceutical, immunobiological drugs, blood and blood substitute drugs) and is mandatory for all subjects of drug circulation.
State quality control of medicines is carried out in the form:
Preliminary quality control of medicines;
Selective control of the quality of medicines;
Repeated selective control of the quality of medicines;
Quality control of vegetable, animal or synthetic origin, which have pharmacological activity and intended for the production of drugs;
Periodic inspections of enterprises - manufacturers of drugs located in the territories of the constituent entities of the Russian Federation in order to inspect the quality of drugs produced by them.
Order No. 137 contains the following sections:
I. General provisions.
II. Preliminary quality control of medicines.
III. Selective quality control of medicines.
IV. Re-selective quality control of medicines.
V. Quality control of plant, animal, microbial or synthetic origin, which have pharmacological activity and intended for the production of medicines.
Vi. The order of selection, direction and storage of drug samples for the implementation of state control of the quality of medicines.
Attachment 1.Decision on the production of medicines.
Appendix 2.Act of the sampling of medicines.
In conclusion of this chapter, it should be said that the manufacture of drugs is a separate sectorate of economics, which has both social and economic significance. Therefore, almost all work is subject to state rationing and regulation. The provision in the pharmacy institution should mostly control the compliance of pharmaceutical and sanitary procedure with the norms of legislation. Only complete correspondence will allow to make high-quality, efficient and safe drugs.
Lecture number 2.
1. What is the state rationing of drug production?
2. What are the rationing directions? What is their validity?
3. Who and on what basis has the right to prepare drugs?
4. How is the composition of the drug? What are standard and non-standard recipes?
5. What is a recipe? What is his structure?
6. Is it possible to prepare a drug prescription if a single dose of the substances of the list A and B is overstated in the recipe? How should the provisional technologist do?
7. What is State Pharmacopoeia, Pharmacopoeia
and temporary pharmacopoeia articles?
8. What are the features of the GF? What changes are in the GF compared with the GF X?
9. How are the conditions for the production of drugs?
10. What are the temporary norms of non-pathogenic microorganisms in non-sterile drugs? What microorganisms should be missing and why?
11. Objects of selective bacteriological control served: air production premises, Medicinal and auxiliary materials. Is it correct?
12. What orders are the technological process of making drugs?
13. What are the main rules for design drugs? List the main labels and additional inscriptions.
14. What orders are the quality of drugs?
Tests
1. Persons who received are allowed to occupy pharmaceutical activities:
1. Higher or secondary medical and pharmaceutical education, which have a diploma and special title, and on the occupation of certain types of activities, the list of which is established by the Ministry of Health and Social Development of the Russian Federation, is also a certificate of a specialist and a license.
2. Higher or medium medical pharmaceutical education, having a diploma and special title.
2. The certificate of a specialist indicates the achievement of its owner of a certain level:
1. Theoretical knowledge, practical skills and skills sufficient for independent medical and pharmaceutical activities.
2. A certain level of knowledge sufficient for independent medical and pharmaceutical activities.
3. A certain level of knowledge.
3. The certificate of the specialist is confirmed:
1. Every 5 years after appropriate training in state or municipal systems of additional vocational education According to the results of the Quarter's Exam.
2. Every 7 years after appropriate training in state or municipal systems of additional professional education based on the results of the qualifying exam.
3. Every 5 years.
4. Middle Diploma pharmaceutical education First:
1. Five years after receiving it equal to the certificate of a specialist, with the exception of specialties requiring additional preparation.
2. Ten years after receipt it is equal to the certificate of a specialist, with the exception of specialties requiring additional training.
5. Students who graduated from 4 or more courses of higher medical or pharmaceutical educational organizations:
1. Can be engaged in professional activities under the control of a specialist.
2. Can not engage in professional activities under the control of a specialist.
6. Persons having a degree of doctor of pharmaceutical sciences, certificate of a specialist in the relevant specialty:
1. issued.
2. Not issued.
7. Choose the right statement:
1. Medical I. pharmaceutical workerswho have not worked in their specialty for more than 5 years, can be admitted to professional activity After additional preparation and confirmation of a specialist certificate.
2. Medical and pharmaceutical workers who have not worked in their specialty for more than 3 years can be admitted to professional activities after additional preparation and confirmation of a specialist certificate.
8. The qualification exam, conducted to obtain a certificate of a specialist, aims to determine:
1. The readiness of a specialist for independent medical and pharmaceutical activities.
2. The level of theoretical and practical knowledge of medical and pharmaceutical activities.
3. The level of theoretical knowledge on the disciplines studied, practical skills, as well as knowledge of the legislation of the Russian Federation.
9. Narcotic agents, psychotropic substances and their precursors are entered into the following lists:
1. The list of narcotic drugs and psychotropic substances, the turnover of which is prohibited, - List I.
2. The list of narcotic drugs and psychotropic substances, the turnover of which is limited and for which control measures are established - list II.
3. The list of psychotropic substances, the turnover of which is limited and in respect of which is allowed to exclude some measures - list III.
4. The list of narcotic drugs and psychotropic substances, whose turnover in the Russian Federation is resolved, - list V.
5. The list of precursors whose turn is limited and for which control measures are established.
10. Principles public Policy in the sphere of narcotic drugs, psychotropic substances:
1. State monopoly on the main activities related to the turnover of narcotic drugs, psychotropic substances.
2. Licensing of all types of activities related to the turnover of narcotic drugs, psychotropic substances.
3. Coordination of the activities of federal executive bodies, executive authorities of the constituent entities of the Russian Federation, local governments.
4. Restriction of the list of persons who have admission to the operation with narcotic substances.
11. Select an invalid answer:
1. Production of narcotic drugs or psychotropic substances listed in List II is carried out by state or municipal unitary enterprises.
2. Production and manufacture of psychotropic substances listed in List III are carried out by enterprises and institutions regardless of the forms of ownership.
3. Production and manufacture of psychotropic substances listed in List II are carried out by enterprises and institutions regardless of ownership.
4. The manufacture of narcotic drugs or psychotropic substances listed in the list III is carried out by state or municipal unitary enterprises.
12. Production and manufacture of narcotic drugs and psychotropic substances listed in List II are carried out:
1. Within state quotas by state unitary enterprises and government agencies.
2. The agencies in federal property.
3. If licenses for the production of specific drugs and psychotropic substances.
4. Enterprises of other forms of ownership when obtaining relevant permits of the Ministry of Health and the Ministry of Internal Affairs of the Russian Federation.
13. Narcotic drugs and psychotropic substances made in lists II and III are released:
1. By prescription. 2. Without a recipe. 3. By recipe, written less than 5 days ago.
14. When carrying out activities related to the turnover of precursors listed in List IV, any operations under which the number of precursors is subject to:
1. Registration in special magazines. 2. Subject and quantitative accounting.
15. Narcotic funds should be stored in safes, while:
1. Safes must be in a closed state.
2. After the end of the working day, they must be sealing or segged. Keys from the safe, printing and seal must keep materially responsible persons who are authorized by orders for healthcare facilities.
3. Safes must be screwed to the walls or installed so that the door unlocked inside the room at an angle of not more than 30 degrees.
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the State Inspectorate for the Quality Control of Medicines of the Ministry of Health of Ukraine was created by the Order of the Ministry of Health of Ukraine in 1992, the authority, the structure of the State Inspectorate on Control Quality of Medicines of the Ministry of Health of Ukraine and its right officials Defined by the Law of Ukraine "On Medicines" from
According to the legislation of Ukraine, the State Inspectorate on Quality Control of Medicines of the Ministry of Health of Ukraine is special organ State control of the quality of medicines with directly subordinate state inspections for the quality control of medicines in the Autonomous Republic of Crimea, regions, cities of Kiev and Sevastopol.
the State Inspectorate for the Quality Control of Medicinal Medicines of the Ministry of Health of Ukraine is headed by the chief state inspector of Ukraine - Deputy Minister of Health of Ukraine, who is appointed to the position and dismissed by the President of Ukraine.
His deputies are deputy chief state inspector of Ukraine to control the quality of medicines. The heads of state inspections on the quality control of medicines in the Autonomous Republic of Crimea, regions, cities of Kiev and Sevastopol are both main state inspectors, and their deputies - according to the deputies of the main state inspectors to control the quality of medicines. Other specialists of state inspections on which the implementation of state control over the quality of drugs is entrusted, simultaneously are state inspectors for the quality control of medicines.
The Regulation on the State Medicinal Quality Control Inspectorate was approved by the Decree of the Cabinet of Ministers of Ukraine of 02.16.1998 No. 179.
The main functions of the state inspection According to the quality control of the medicines of the Ministry of Health of Ukraine:
o Implementation of state control over the quality of medicines during their production, implementation and application in Ukraine;
o Organization and carrying out measures for seizures from the treatment of medicines, raw materials and materials that do not meet the requirements of regulatory documents;
o Implementation of the importation of drugs into the customs territory of Ukraine of medicines;
o Conducting an assessment of the effectiveness of the organization of quality control systems of medicines in the process of their production;
o holding certification and accreditation of laboratories for the analysis of the quality of medicines, monitoring their work and checking their activities.
The State Inspectorate for the Quality Control of Medicines of the Ministry of Health of Ukraine has in subordination of 27 territorial state inspections in the Autonomous Republic of Crimea, regions, cities of Kiev and Sevastopol. Territorial government inspections have 28 laboratories.
The main functions of territorial state inspections:
Inspection checks wholesale and retail medicines and medical products;
Visual control of the quality of medicines and medical products, which have passed input control authorized persons in pharmacies and wholesale pharmaceutical firms;
Selective control for laboratory analysis of drug samples in pharmacies and wholesale pharmaceutical firms;
Ensuring controlling the quality of medicines and medical products in the event of conflicts between consumers and suppliers.
Today, the State Inspectorate for the Quality Control of Medicines of the Ministry of Health and Territorial Inspectorates has the necessary computer technique and modern means of communication (fax, email). The information department of the State Inspectorate of the Ministry of Internal Affairs receives official information about drugs registered in Ukraine, analytical regulatory documentation (Andes) from the State Pharmacological Center, relevant databases and provides this information to all territorial state inspections. Such information support allows state inspections to effectively conduct activities to identify and withdraw from the market for falsified, poor-quality and unregistered drugs.
All drugs produced on the territory of the Russian Federation and imported on its territory are subject to state control. The procedure for the implementation of state quality control, efficiency and safety of LC is established by the law "On Medicines", regulatory legal acts of the Russian Federation, relevant federal executive bodies.
State regulation in the field of circulation LC is carried out by the federal executive body and bodies state power The constituent entities of the Russian Federation, whose competence includes the implementation of state quality control, efficiency, LC security. In connection with the Decree of the Government of the Russian Federation "On the approval of the" Regulations on the licensing of medicinal production "of July 4, 2002 No. 500, one of these provisions is the training of specialists who can organize work on the production of high-quality LCs.
The state quality control system, efficiency and security LC includes:
the federal executive body and the executive authorities of the constituent entities of the Russian Federation, whose competence includes the implementation of state control of the quality, efficacy and safety of LC, supervision of pharmaceutical activities and other actions in the field of drug circulation;
research institutions, laboratories for the development, research and implementation of state quality control, efficiency and safety of drugs;
expert advice on the appeal of HP under the Government of the Russian Federation;
ethical advice in force with healthcare institutions.
Public authorities carrying out control functions. The rights and obligations of the federal executive authority and the executive bodies of the constituent entities of the Russian Federation, which includes the implementation of state quality control, efficiency and safety of drugs, are determined by the Law on Medicines. The federal body authorized by the Government of the Russian Federation to monitor the quality control, efficacy and safety of drugs, is the only federal executive body responsible for the implementation of state quality control, the effectiveness and safety of drugs in the Russian Federation, independently for all matters relating to its competence.
State veterinary supervision is the activities of government agencies, institutions and organizations of state veterinary service Of the Russian Federation, aimed at preventing animal diseases and ensuring the safety of animal products by preventing, detecting and preventing violations of veterinary legislation. The objectives of the State Veterinary Supervision are the establishment of the procedure for production and use in veterinary medicine of biological, chemical and other drugs, implementation special events on the protection of animals from the striking effects of extreme factors, natural and man-made disasters, etc. The State Veterinary Supervision is carried out at biological plant and factories, in research and development workshops, bases and enterprises of biological supply, veterinary pharmacies and other enterprises for production, storage and sale of drugs and technical means Veterinary appointment.
Directly, the State Veterinary Supervision is carried out by Rosselkhoznadzor with directly subordinate FGU VGHKS, central scientific and industrial and radiological laboratories and others control bodies Veterinary medicine authorized by the law "On Veterinary". Heads this service chief state veterinary inspector of the Russian Federation.
In order to ensure state quality control, efficiency and security LC, the federal quality control body can create territorial bodies Control or by agreement with the executive authorities of the constituent entities of the Russian Federation transfer them their powers in this area.
The federal quality control body of veterinary drugs (FGU VGNK) Along with others, carries out the following activities:
examination of the quality, efficiency, safety of veterinary drugs produced in the Russian Federation and imported into its territory;
formation of the Pharmaceutical Council under the federal LC quality control body for the treatment of animals and ensuring its activities;
approval of texts for standards and technical conditions veterinary preparations;
collection and generalization of data on the use, side effects and features of the interaction of veterinary drugs;
development and approval of the State Standard of Quality LC for the treatment of animals and state information Standard;
development and approval of the rules for organizing production and quality control of veterinary drugs, rules for their manufacture, rules wholesale trade drugs used in veterinary medicine;
examinations of veterinary and sanitary and hygienic and epidemiological security production of drugs; development and approval of laboratory practice rules; issuance of conclusions on the conformity of the organization of veterinary medicinal drugs with the requirements of the Law on Medicines in Licensing the production of such drugs;
control over the implementation by enterprises - manufacturers of LS for animals rules for organizing production and control of their quality;
interaction with federal executive bodies, whose competence includes licensing production of drugs and foreign trade activities;
supervision of veterinary preparations; certification of veterinary drugs.
The federal body quality control body checks manufacturing enterprises and conducts their certification. Territorial LAN quality control bodies on behalf of the federal body periodically conduct a check of enterprises - manufacturers of drugs located in the territory of the respective subjects.
The federal body quality control body and its territorial bodies have the right to:
having unhindered access to any enterprise - manufacturer of drugs, to withdraw product samples;
make copies of the documents required for controlling the production and quality of drugs;
to prohibit the production and sale of already produced by drugs in cases of an exhaustive list of which is contained in the rules of organization of production and quality control of the LS.
State quality control in the field of treatment of medicines since sincerversion existed in Russia. Nowadays, such control is carried out using the following measures:
licensing of drug production; Organization of multi-level inspection control of compliance with established norms and rules, involving in this activity and teams of manufacturers in self-obspection;
creating regulatory legal baseregulating the treatment of medicines (primarily the standards of the GXP series);
administrative measures suppression of production of products that does not correspond to the quality of the quality of medicines;
organization of scientific research in pharmacology and in the field of fundamental science (chemistry, physics, biology, biotechnology and other directions).
In the Russian Federation there is a certain base of regulatory legal documents, regulating quality control in the production of veterinary drugs, but it would be premature to consider it exhaustive.
Existing laws "On Medicines", "On Veterinary Engine", "On Licensing separate species activities, other regulatory legal acts And international agreements regulating the production of medicines establish the priority of quality and its control at the state level. Medicinal quality control mechanisms are identified: LC registration has been established, the system of their certification is introduced, licensing and inspection of manufacturers is mandatory, GOST R 52249-04 "Rules of production and quality control of medicines" is introduced.
Improving the regulatory framework can significantly increase the state influence on the process of managing the quality of pharmaceutical products. However, the issues of the control system structure and the authorities of the controlling bodies are not yet defined.
The procedure for conducting state control (supervision). State control (supervision) for compliance with the current legislation in the field of safety and quality of medicines is subject to all LCs in circulation. Activities for this control (supervision) are aimed at checking compliance with the requirements of drug safety for animals and humans, processes of development, testing, manufacturing, manufacturing, storage, transportation, sales and disposal.
State control (supervision) for drugs is carried out by an authorized federal body in the manner prescribed Federal law "On the protection of the rights of legal entities and individual entrepreneurs in conducting state control (supervision)" of August 8, 2001 No. 134-PE and in force technical Regulations. Activities for state control (supervision) are carried out on the basis of an order (order) of the authorized federal authority of the Commissioner state Organizationincluded in the structure of the federal body (FGU VGNK).
State control (supervision) is carried out in accordance with the plan providing for its holding no more than once every two years.
Explanatory measures for state control (supervision) can be carried out in cases:
monitoring the execution of prescriptions to eliminate violations of security requirements and ensuring the quality of drugs identified when conducting planned control (supervision);
the occurrence of the threat of life and health of animals, people and the environment;
the appeals of citizens, legal entities and individual entrepreneurs with complaints of violation by the subjects of drug conversion of security requirements in the manufacture of medicines.
The duration of measures for state control (supervision) should not exceed one month. In exceptional cases related to the need for special tests, examinations requiring work of significant volume and duration, control (supervision) can be extended for a period not exceeding another month.
The results of control (supervision) are drawn up by the act, on the basis of which a decision is made on the compliance or inconsistency of the subject of drug circulation to the requirements of this Regulation. The identified violations are required to eliminate drug circulation entities within a set period of time. After eliminating violations, a decision is made to comply with the subject of drug circulation to the requirements of the technical regulation.
Representatives of the federal executive body, whose competence includes the implementation of state control and oversight of the treatment of medicines for animals, has the right to:
unhindered on the basis of the prescription to access any subject of drug circulation;
clear the samples of drugs in the amount required for their research in accordance with the requirements regulatory documentation, make copies from documents related to the appeal of drugs;
prohibit or suspend the production and sale of medicines that pose a threat to human life and animal health, and the environment;
direct disabilities, falsified and illegally referred to in the territory of the Russian Federation drugs.
State inspection and quality of medicines
The chief state veterinary inspector of the Russian Federation is simultaneously the head of the Rosselkhoznadzor. In his immediate submission are deputies, the heads of the departments of Rosselkhoznadzor - Deputy Chief Veterinary Inspector, the main and leading veterinary doctors of the Departments of the Rosselkhoznadzor - State Veterinary Inspectors, as well as the main veterinary inspectors of the constituent entities of the Russian Federation - heads of departments and veterinary management of subjects with their subordinates - state veterinary inspectors Subjects.
State veterinary inspectors are inspected at the supervised facilities for production, storage, manufacturing (in veterinary pharmacies) and the implementation of veterinary drugs. Objectives, volume and frequency of inspections, the procedure for registration according to their results of relevant documents (acts, protocols, regulations, regulations) and decision-making, as well as the procedure for the implementation of measures to curb the violations of veterinary legislation of the Russian Federation are determined by the rules, instructions, instructions and other regulatory documentspublished and approved executive bodies Based on existing legislation.
Depending on the specific conditions and verification tasks, the following types of inspection are used: a complete scheduled inspection, abbreviated inspection check, subsequent (re-) inspection, special check.
The full scheduled inspection provides for a total validation of the enterprise for all existing GMP sections, license provisions and requirements.
The abbreviated inspection check is reduced to selective control of the limited number of GMP requirements, which are selected by the inspector as the most characteristic performance indicators on a specific production.
Subsequent (re-) inspection is made to control the execution of work to eliminate the previous planned verification of Violations of GMP requirements. The timing of it is established in accordance with the plan to eliminate deficiencies. The plan is submitted to the control unit no later than 30 days from the date of the inspection check.
Special enterprise check is carried out upon admission to Rosselkhoznadzor:
messages about serious adverse reactions caused by the drugs issued by the enterprise.
In addition, special checks are appointed: at the request of other ministries and departments; as preliminary condition Authorization of export supplies.
For special check Inspectors are checked: production of a separate drug or dosage form;
performing individual technological operations (weighing, sterilization, marking, etc.);
functioning of any manufacturing system of the enterprise (water treatment, ventilation, etc.).
The frequency and duration of inspection are determined by the type of inspection, the size of the enterprise, the purpose of inspection, the amount of work and the number of inspectors participating in the inspection. It can continue from a few days to two weeks and more.
Inspections should be held regularly on schedule, preferably every year. Large companies selling a wide range of products are subject to inspection for a longer period, but within three years, since this is a license validity period. New production enterprises should be inspected before their licensing, and new technical means - before the start of their use in the technological process.
State monitoring of medicines was established legislatively established and prohibited their issue with violation of the rules for organizing production and quality control.
Citizens, individual entrepreneurs and legal entities guilty of violation current law and / or technical regulations are administrative and criminal liability In accordance with the legislation of the Russian Federation.
Harm caused to life or health of people, animal and the environment as a result of processes of production and manufacture, storage, transportation, implementation, application and disposal of medicines that do not meet the requirements established by these technical regulations are subject to a citizen reimbursement, individual entrepreneur and / or legal entitywho caused harm in accordance with the legislation of the Russian Federation.
When conducting a state inspection, designated experts are endowed with broad powers that are enshrined by law. The federal body quality control body and territorial control authorities have the right to: unhindered access to any enterprise - Manufacturer LC, to withdraw the samples of drugs produced;
remove copies from the documents required for the control of production and quality LC;
to prohibit production of drugs and the sale of already produced by drugs in cases, an exhaustive list of which is contained in the rules for organizing production and quality control of drugs.
In the daily practice of inspection control, the following assessment criteria and measures are used, adequate violations:
non-compliance with the requirements of the GMP standard; Deviation from the requirements of the GMP standard (critical, significant or significant, insignificant or minor, comments).
In the process of verification, the inspector must ensure that the following requirements are followed by issuing permission to issue each series of products to implement the following requirements: the product series complies with the requirements of the appropriate pharmacopoeia article, GOST, TU and license;
complied with the implementation of the principles and rules for adequate production practices established by the GMP standard;
the main technological processes and test techniques passed validation;
everyone was held necessary checks and tests, executed protocols and other registration records;
before the implementation of products, the controlling agency provides information about changes in production and quality control in accordance with the established information system;
additional sampling, control, testing and checks were carried out and are configured to resolve the intended changes and deviations;
all necessary documentationconcerning the technological process and quality control, completed and signed (approved) by competent controllers;
experienced and trained personnel conducted appropriate quality, self-inspection audits and selective checks;
in the formation of documentation (dossier on the series), all factors that may have an impact on quality were taken into account;
the head of the quality control department (OCC) was issued permission to issue.
In the last decade, almost annually in the media reported on outbreaks of hazardous diseases among people and animals, terrible catastrophes, wars and other emergencies. People and animals are suffering in these misfortunes. The world has not yet survived a fully shock from the news of the so-called "cow's rabies", which covers the European continent, and already in turn of the lush, bird flu, classical plague plague, brucellosis. All in the memory of the formidable earthquakes and tsunami, war ... and this list can be continued and continued. Damage caused by diseases, wars and elements to the population and economies of affected countries is huge. Affected by emergency situations Serious medical care is always required. Therefore, the world is growing need for medicines for both people and animals.
But in ordinary peaceful life, each person sooner or later resorts to the help of medicines. Moreover, a significant part of the population continues to live and work only thanks to constant medication support, which generates a number of serious problems. There is no state in the world that could fully ensure the ever-increasing need of veterinary medicine and medicine in medicines at the expense of its own production. The pharmaceutical market is built on a wide international exchange and requires a solution to a number of issues related to the product quality certificate. The tragic consequences of the use of drugs are widely known.
According to statistical data, more than 100 thousand people die every year from the use of medicines, and among the causes of death - the use of drugs is three times higher than the death rate from car accident, ranking fourth after heart, oncological diseases and stroke. Such a picture is observed in other countries. In 2001, the cause of the death of an approximately one hundred people was the use of the drug Baykol of the world-famous pharmaceutical firm Bayer (O. E. Nifanthev, 2003). Sad statistics are replenished annually.
To minimize the likelihood of the implementation of negative factors, the world community and individual countries are taking strict measures. Formulated general requirements Development, registration, production and inspection control. As a result of broad international integration occurs rapprochement of the level of regulatory requirements in the field of production and quality control of medicines. Hence, a very responsible attitude to the inspection service, which is constantly developing, is improved and supported by international organizations.
In relation to the manufacturer, control is external ( state inspection) and internal (self-technical). A number of organizations have been created in the framework of the World Health Organization, the European Union and others international organizations on the control of the development, production and implementation of drugs. Installed regulatory legal acts and interstate agreements aimed at ensuring quality control in the field of drug circulation. Among them are the most important are the standards of GLP, GCP, GMP and GPP.
International Standards ISO 8402 series view quality systems as an inseparable unity organizational structure, responsibility of participants in circulation, methods of research, processes and resources necessary to implement the general manual.
Inspectorate of drug manufacturers (inspection for compliance with GMP - GMP Inspection) - a mandatory procedure for controlling the production of medicines provided for by the Rules of Good Industrial Practice - GMP and adopted in all countries producing medicines. It is confirmed by examining and presenting objective evidence that the established requirements are fully implemented.
Quality control of medicines is an important function of the state, it establishes uniform rules and rules for all manufacturers, taking into account the provisions agreed in the process of international cooperation. The pharmaceutical market is based on a wide international exchange of products. This implies the need for the unity of requirements for the quality systems for drug producers. It should be noted the overall tendency to transfer the accent from controlling the quality of finished drugs to control production. The main principle - the quality should be laid into the product and are monitored in the production process.
Inspection tests of drug manufacturers is carried out by the Department of State Quality Control, the effectiveness, security of medicines and medical equipment (hereinafter - the Department). According to his instructions, the inspection is carried out inspection of drug treatment of the scientific center of examination and state quality control of the Ministry of Health and Social Development of Russia (NC Egls, further - inspection) or territorial body quality control bodies. Inspection production checks are carried out in the following modes:
planned inspection (complete or ordinary, abbreviated or short);
subsequent or re-inspection;
special inspection.
It is very important to establish the norms and rules for the relationship of participants in the field of medicinal products, including self-specific with the structures of external control of quality systems. It is necessary to clarify who at what stage of the interaction of these subjects represents the interests of the parties, their powers and responsibility. It is important to emphasize the main thing. Control services, Whether it is a state inspection or self-specification of a private enterprise, are units of one chain, have one goal - quality management.
For control of pharmaceutical production, the following forms of inspection checks are used:
1. External. Within the framework of state control: on the accreditation of the OKC laboratories, through the licensing body, through domestic lenders and investors.
According to the customer's line as part of work under contracts.
International: through international organizations, through foreign lenders and investors, within the framework of contractual agreements, within the framework of trade agreements.
2. Self-inspection: planned, unscheduled, quality audit, supplier audit, audit contracts.
It should be emphasized that the self-specific quality of quality systems is considered in the form of one of the important elements in the system of multi-level inspection control of medicines.
Self-inspection as part of a unified quality management system
Self-inspection at the pharmaceutical enterprise is an integral component of the quality management system and should find a worthy place in the documents defining the quality policy of the enterprise. This is determined by GOST R 52249-04 "Rules for the production and quality control of medicines" and a number of decision-making documents of the Ministry of Health and Social Development of Russia and the Ministry of Education and Science of Russia. The main purpose of self-specific is an assessment of the manufacturer's compliance with the requirements of GMP in all aspects of the technological process and quality control.
Self-inspection makes it possible to identify the slightest deviations from installed order And do not give to develop critical deviations, even more inconsistencies, the GMP standard. It is provided as a mandatory component in the Rules for the proper production practice of all countries. The importance of self-technical confirms also extensive between
people's experience of using it in various fields of activity, primarily requiring high quality standards or related risk-related. There are in mind the risks associated with both the nature of production products and the danger to personnel in the production process.
Aspectation of self-specific from the standpoint of quality control systems in the production of medicines, it should be considered in a number of the most important elements of a multi-level expert system. External inspection and self-inspection - complementary elements unified system Quality management. It does not have a decisive importance who organizes the audit, the state supervisory authority or the enterprise administration. They are combined with a common idea aimed at implementing a strategic goal - global quality management in the production of medicines. This is especially important.
Self-inspection in the domestic industry in one form or another always existed as an element in general state system Quality management. But it was not formalized and strictly regulated, although it was constantly implemented in the form of days of quality, cross inspections, etc. With the development of a national systemic crisis in the 90s of the last century, the tip of liberal reforms was first aimed at the control system in any His manifestations that in time coincided with a sharp transition to the redistribution of property.
The new owners due to the insufficient experience of ownership and management of production avoided any form of control, including inspection of quality systems, especially with the participation of the team. However, circumstances demanded international contacts. Integration into the global economic and social community was necessary and turned out to be impossible without harmonizing generally accepted systems, including quality control in pharmaceutical production. It was necessary to adapt the conditions for the production of medicines to the requirements of the GMP adopted in all developed countries. By the way, it turned out that abroad is not only not afraid of inspection, on the contrary, in every way develop inspection control, primarily self-specific, universally established as compulsory licensed requirement.
The self-technical quality of quality systems is different from self-inspection at all. Inspection in enterprises producing drugs involves checking all parties to activities. Each service (sanitary, technical, energy, etc.) is obliged to organize inspections in its field of activity, but they are administrative. When it comes to self-technical, refers to checking those manufacturing relations, processes and procedures that directly provide and determine the quality of the produced drugs.
In international practice, self-technical is provided for by the GMP standard, in Russia it is established in the form of section GOST R 52249-04 "Rules of production and quality control of medicines". The purpose of self-specific is an assessment of compliance with the requirements of GMP rules in all aspects of the technological process and quality control.
When achieving the goal, the following tasks are solved:
total control of the technological process; quality control at all stages of the production process, at each workplace;
attracting the entire production personnel to active participation in controlling the quality management system;
ensuring the most efficient use of equipment, consumables and materials;
awareness by each employee of the enterprise that even the slightest deviation from the established procedure can turn into a consumer with severe consequences up to a deadly outcome;
education in personnel sense of responsibility; Ensuring the continuity of generations.
Self-obspection solves the problem: actually control;
implementation of the educational system (self-technical) as an element of the personnel training program.
For the self-technical system, tasks must be clearly defined, the solution of which will ensure the main thing - the achievement of a high level of product quality.
At the first stage of the transition to work within the framework of the Rules of Good Working Practices, all organizational issues should be solved on the creation of a self-technical system (the order of the company's head, the formation of the structure, the development of enterprise standards, instructions, samples of the system documents, the educational component in the specifics of personnel, etc.).
At the second stage, when a stable work is reached within the GMP rules, it follows:
constant control of all production units and services in the framework of the quality management system through systematic self-inspections;
to identify the slightest deviations from the GMP rules and promote their operational elimination;
organize external audit of suppliers and contractors.
One of the components of the self-specific activity and the function of quality assurance department is to audit quality. The concept of "quality audit" includes an independent analysis of the production situation in all units and enterprise services and services on the basis of self-technical. This allows you to determine the compliance of activities and results in the quality of the planned activities, as well as assess the effectiveness of the introduction of new technologies and their suitability for achieving the goals. Quality audit is in continuous observation and verification of the state of the object, examination and evaluation of the entire quality system or its particular part in order to certify that the established requirements are strictly implemented.
An audit of suppliers includes checking premises, technical means, documentation and products supplied by the provider, in order to determine their compliance with the established requirements. The supplier history, its image and the nature of the supplied substances are taken into account. The audit should determine the supplier's ability to comply with GMP standards for pharmaceutical ingredients and substances.
To introduce self-specific in everyday practice, the formalization of the system is needed, which involves the development of the organizational structure, methodology, documentation, the formation of the self-technical group and the study of the asset.
The fundamental principles of the system are: the mandatory participation of personnel in ensuring control of compliance with proper practice;
assimilation by each employee of ideology, GMP philosophy; emphasis on the main thing - achieving quality through effective control at all stages of production and in all positions; total coverage of production;