State supervision and control over the circulation of medicines. The structure of the state system of quality control of medicines State Inspectorate for quality control of medicines

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Letters from the State Inspectorate for Quality Control of Medicinal Products of the Ministry of Health of Ukraine

Letter dated May 7, 2001 No. 988/12-04

According to the results state control samples sent by the State Inspectorate for Quality Control of Medicines in Kyiv, it is prohibited to sell the drug "Sigan", tablets No. India, which does not meet the requirements of the ANDE for the registration certificate No. R.02.00/01339 dated February 2, 2000 in terms of "Description" (tablets with orange spots and inclusions, with an unevenly applied shell).

It is proposed to take appropriate measures to withdraw these batches of the drug from sale and to check other available batches regarding their compliance with regulatory requirements in terms of the "Description" indicator.

If it is established that other batches of the drug do not comply with the requirements of the AED for the indicated indicator, take local measures.

To report on the execution of the order to the State Inspectorate of the Ministry of Health before 5.06.2001.

Letter dated May 15, 2001 No. 1015/12-04

Heads of state inspections for quality control of medicines in the Autonomous Republic of Crimea, regions, cities of Kyiv and Sevastopol

According to the State Inspectorate for Quality Control of Medicines in the Kirovograd and Poltava regions, during inspections of business entities, medicines not registered in Ukraine were identified, which is a violation of Art. 20 of the Law of Ukraine "On Medicines" dated April 4, 1996 No. 123/96-BP, namely:

ibuprofen, tablets 0.2 g No. 10 p. 400500 manufactured by Borisovsky ZMP, Republic of Belarus;
solution of analgin 50%, 2 ml No. 10 s. 700800 manufactured by Borisovsky ZMP, Republic of Belarus;
solution of chloramphenicol 0.25%, 10 ml s. 18082000 manufactured by FAO Bryntsalov-Ferein, Russian Federation;
furadonin, tablets 0.2 g No. 10 p. 150100 manufactured by Borisovsky ZMP, Republic of Belarus;
peppermint leaf 50 g in packs with. 101000 manufactured by MP "Vita" (Poltava region, Lubensky district, Zasulye village)

Based on the foregoing, it is proposed to carry out an appropriate check and take urgent measures to withdraw the above-mentioned unregistered medicines from circulation.

If unregistered products are identified in the sphere of circulation, determine the source of their receipt and take appropriate measures in accordance with the law to all entities selling medicines unregistered in Ukraine.

If the seized samples of the drug do not comply with the requirements of the ANDA, take appropriate measures on the ground.

Report the results of the inspection and the measures taken to the State Inspectorate for Quality Control of Medicines of the Ministry of Health before 15.06.2001.

Letter dated May 16, 2001 No. 1022/12-04

Heads of state inspections for quality control of medicines in the Autonomous Republic of Crimea, regions, cities of Kyiv and Sevastopol
Director of OAO "Monfarm" Chernyshov S.I.

The State Inspectorate for Quality Control of Medicinal Products in Kyiv identified “Phthalazole Tablets” of 0.5 g each, series 50800 manufactured by Monfarm OJSC, which do not meet the requirements of VFS 42U-36-509-97 in terms of “Disintegration”. The conclusion of the inspection was confirmed by the Central Laboratory for the Analysis of the Quality of Medicinal Products. At the same time, the Central Laboratory carried out an analysis of samples of the above tablets from among the archival control samples of the manufacturing enterprise, which also do not meet the regulatory requirements in terms of “Disintegration”. If non-compliance with the requirements of the AND for the indicated indicator of other series is established, immediately inform the State Inspectorate of the Ministry of Health with the simultaneous sending of samples of the drug to its address.

Report on the execution of the order before 25.06.2001.

The manufacturer of the medicinal product is requested to recall the 50800 series fthalazole tablets 0.5 g from consumers and take appropriate measures regarding the specified substandard product lot.

Information on the quantity of products released to consumers and returned by them, measures taken for it and measures to prevent further release of the specified drug in violation regulatory requirements submit to the State Inspectorate of the Ministry of Health until 20.06.2001.

Letter dated May 16, 2001 No. 1026/12-04

Heads of state inspections for quality control of medicines in the Autonomous Republic of Crimea, regions, cities of Kyiv and Sevastopol

We inform you that in accordance with the letter of the State Inspectorate for Quality Control of Medicines of the Ministry of Health of Ukraine (No. 161/16-01 dated April 24, 2000), addressed to the heads of enterprises manufacturing medicines, regarding proposals for combating counterfeit medicines, JSC " Kievmedpreparat, starting with series 270401 of Cefazolin-KMP at a dose of 1.0 g and series 160501 of Ceftriaxone-KMP at a dose of 0.5 g, introduces the use of metal caps with a blue paint coating.

The use of blue caps as an element of product protection against falsification will be used by the enterprise in the future in the production of cephalosporin drugs, namely: Cefazolin-CMP, Ceftriaxone-CMP, Cefoperazone-CMP, Ceftazidime-CMP.

I propose to convey this information to all business entities selling medicines.

First Deputy Chief State Inspector of Ukraine for Quality Control of Medicinal Products V. G. Varchenko

to the State Inspectorate for Quality Control of Medicines of the Ministry of Health of Ukraine was established by order of the Ministry of Health of Ukraine in 1992. Powers, structure of the State Inspectorate for Quality Control of Medicines of the Ministry of Health of Ukraine and its rights officials defined by the Law of Ukraine "On Medicines" dated

According to the legislation of Ukraine, the State Inspectorate for Quality Control of Medicines of the Ministry of Health of Ukraine is special body state control of the quality of medicines with directly subordinated state inspections for quality control of medicines in the Autonomous Republic of Crimea, regions, cities of Kyiv and Sevastopol.

The State Inspectorate for Quality Control of Medicinal Products 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 and dismissed by the President of Ukraine.

His deputies are deputies of the Chief State Inspector of Ukraine for quality control of medicines. Heads of state inspections for quality control of medicines in the Autonomous Republic of Crimea, regions, cities of Kyiv and Sevastopol are at the same time the main government inspectors, and their deputies - respectively, deputies of the chief state inspectors for quality control of medicines. Other specialists of state inspections, who are entrusted with the implementation of state control over the quality of medicines, are at the same time state inspectors for quality control of medicines.

Regulations on the State Inspectorate for Quality Control of Medicinal Products was approved by Resolution Cabinet of Ministers of Ukraine dated February 16, 1998 No. 179.

Main functions of the State Inspectorate for quality control of medicines of the Ministry of Health of Ukraine:

o implementation of state control over the quality of medicines during their production, sale and use in Ukraine;

o organization and implementation of measures to withdraw from circulation medicines, raw materials and materials that do not meet the requirements of regulatory documents;

o control over the import of medicines into the customs territory of Ukraine;

o assessing the effectiveness of the organization of quality control systems for medicines in the process of their production;

o carrying out certification and accreditation of laboratories for the analysis of the quality of medicines, monitoring their work and checking their activities.

The State Inspectorate for Quality Control of Medicinal Products of the Ministry of Health of Ukraine has 27 territorial state inspectorates in the Autonomous Republic of Crimea, regions, cities of Kyiv and Sevastopol. Territorial state inspectorates have 28 laboratories.

Main functions of territorial state inspections:

Inspection checks of wholesale and retail medicines and products medical purpose;

Visual quality control of medicines and medical products that have passed the input control by authorized persons in pharmacies and wholesale pharmaceutical companies;

Sampling for laboratory analysis of drug samples in pharmacies and pharmaceutical wholesalers;

Ensuring quality control of medicines and medical products in case of conflicts between consumers and suppliers.

Today, the State Inspectorate for Quality Control of Medicinal Products of the Ministry of Health of Ukraine and territorial inspectorates have the necessary computer equipment and modern facilities communications (fax, e-mail). The information department of the State Inspectorate of the Ministry of Health regularly receives from the State Pharmacological Center official information about medicines registered in Ukraine, analytical regulatory documentation (AND), replenishes the relevant databases and provides this information to all territorial state inspectorates. Such information support allows state inspectorates to effectively carry out activities to identify and withdraw counterfeit, low-quality and unregistered medicines from the market.

All medicines produced in the territory are subject to state control. Russian Federation and imported into its territory. The procedure for exercising state control over the quality, efficacy and safety of drugs is established by the Law "On Medicines", regulatory legal acts of the Russian Federation, and the relevant federal executive authorities.

State regulation in the field of drug circulation is carried out by the federal executive authority and bodies state power subjects of the Russian Federation, whose competence includes the implementation of state control of the quality, effectiveness, safety of drugs. In connection with the Decree of the Government of the Russian Federation “On Approval of the “Regulations on Licensing the Production of Medicinal Products” dated July 4, 2002 No. 500, one of these provisions is the training of specialists capable of organizing work at the enterprise for the production of high-quality drugs.

The state system for monitoring the quality, effectiveness and safety of drugs includes:

federal executive authority and executive authorities of the constituent entities of the Russian Federation, whose competence includes the implementation of state control over the quality, efficacy and safety of drugs, supervision of pharmaceutical activities and other actions in the field of medicines circulation;

research institutions, laboratories for the development, research and implementation of state control over the quality, effectiveness and safety of drugs;

expert councils for the circulation of drugs under the Government of the Russian Federation;

ethical councils operating in healthcare institutions.

State authorities that carry out control functions. The rights and obligations of the federal executive body and the executive bodies of the constituent entities of the Russian Federation, whose competence includes the implementation of state control over the quality, efficacy and safety of drugs, are determined by the Law "On Medicines". federal body authorized by the Government of the Russian Federation to control the quality, efficacy and safety of drugs, is the only federal executive body responsible for state control of the quality, efficacy and safety of drugs in the Russian Federation, independent on all issues within its competence.

State veterinary supervision is the activity of governing bodies, institutions and organizations of the State veterinary service Russian Federation, aimed at the prevention of animal diseases and ensuring the safety of livestock products by preventing, detecting and suppressing violations of veterinary legislation. The tasks of the state veterinary supervision are to establish the procedure for the production and use of biological, chemical and other drugs in veterinary medicine, the implementation of special measures to protect animals from the damaging effects of extreme factors, natural and man-made disasters and others. State veterinary supervision is carried out at biological plants and factories, in research and development workshops, bases and biological supply enterprises, veterinary pharmacies and other enterprises for the production, storage and sale of drugs and technical means veterinary appointment.

Directly the state veterinary supervision is carried out by the Rosselkhoznadzor with the FGU VGNKI directly subordinate to it, the central research and production and radiological laboratories and others. control bodies veterinary medicine, authorized by the Law "On Veterinary Medicine". This service is headed by the chief state veterinary inspector of the Russian Federation.

In order to ensure state control over the quality, effectiveness and safety of drugs, the federal quality control authority may create territorial bodies control or, by agreement with the executive authorities of the constituent entities of the Russian Federation, transfer to them their powers in this area.

The Federal Body for Quality Control of Veterinary Drugs (FGU VGNKI), along with others, carries out the following activities:

examination of the quality, effectiveness, safety of veterinary drugs produced in the Russian Federation and imported into its territory;

formation of a pharmaceutical council under the federal authority for quality control of drugs for the treatment of animals and ensuring its activities;

approval of texts for standards and specifications veterinary drugs;

collection and compilation of data on the use, side effects and interactions of veterinary drugs;

development and approval state standard quality of drugs for the treatment of animals and state information standard;

development and approval of rules for organizing the production and quality control of veterinary drugs, rules for their manufacture, rules for the wholesale trade of drugs used in veterinary medicine;

expertise of veterinary-sanitary, sanitary-hygienic and epidemiological safety of drug production; development and approval of the rules of laboratory practice; issuance of conclusions on the compliance of the organization of production of veterinary medicinal products with the requirements of the Law "On Medicinal Products" when licensing the production of such drugs;

control over the compliance by enterprises - manufacturers of drugs for animals with the rules for organizing production and controlling their quality;

interaction with federal executive authorities, whose competence includes licensing the production of drugs and foreign trade activities;

supervision of the production of veterinary drugs; certification of veterinary drugs.

The federal drug quality control authority inspects manufacturers and certifies them. Territorial authorities for quality control of drugs, on behalf of the federal agency, periodically inspect drug manufacturers located on the territory of the respective subjects.

The federal drug quality control body and its territorial bodies have the right to:

to freely gain access to any enterprise - manufacturer of drugs, to seize product samples;

make copies of the documents necessary to control the production and quality of medicines;

prohibit the production and sale of already manufactured drugs in cases, an exhaustive list of which is contained in the rules for organizing the production and quality control of drugs.

State quality control in the field of drug circulation has existed in Russia since ancient times. Nowadays, such control is carried out using the following measures:

licensing the production of medicines; organization of multi-level inspection control of compliance with established norms and rules, involving in this activity the teams of manufacturing enterprises within the framework of self-inspection;

establishment of a normative legal framework regulating the circulation of medicines (primarily the standards of the GXP series);

administrative measures suppression of the release of products that do not meet the quality standard of medicines;

organization of scientific research in pharmacology and in the field of fundamental science (chemistry, physics, biology, biotechnology and other areas).

The Russian Federation has 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 Medicine", "On Licensing certain types 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. Mechanisms for managing the quality of medicines have been defined: registration of medicines has been established, a system for their certification has been introduced, licensing and inspection of manufacturers is mandatory, GOST R 52249-04 “Rules for the production and quality control of medicines” has been put into effect.

Improving the regulatory legal framework can significantly increase the state's influence on the process of managing the quality of pharmaceutical products. However, the issues of the structure of the control system still remain unregulated and the scope of responsibility and powers of the control bodies is not defined.

The procedure for conducting state control (supervision). All drugs in circulation are subject to state control (supervision) over compliance with the current legislation in the field of safety and quality of medicines. Measures for this control (supervision) are aimed at verifying compliance with the requirements regarding the safety of medicinal products for animals and humans, the processes of development, testing, production, manufacture, storage, transportation, sale and disposal.

State control (supervision) over medicines is carried out by the authorized federal body in the manner prescribed federal law"On the protection of the rights of legal entities and individual entrepreneurs in the course of state control (supervision)" dated August 8, 2001 No. 134-FE and the current technical regulations. Measures for state control (supervision) are carried out on the basis of an order (order) of the authorized federal body of the authorized state organization, which is part of the structure of the federal body (FGU VGNKI).

State control (supervision) is carried out in accordance with a plan that provides for its implementation no more than once every two years.

Unscheduled measures for state control (supervision) can be carried out in the following cases:

control over the execution of instructions to eliminate violations of safety requirements and ensure the quality of medicines identified during routine control (supervision);

threat to the life and health of animals, people and environment;

appeals of citizens, legal entities and individual entrepreneurs with complaints about the violation by the subjects of medicines circulation of safety requirements in the manufacture of medicines.

The duration of measures for state control (supervision) should not exceed one month. AT exceptional cases related to the need to conduct special tests, examinations that require work of a significant volume and duration, control (supervision) may be extended for a period not exceeding one more month.

The results of control (supervision) are documented in an act, on the basis of which a decision is made on the compliance or non-compliance of the Subject of Medicines Circulation with the requirements of this Regulation. Identified violations are obligatory for elimination by the subjects of medicines circulation within the established period of time. After the elimination of violations, a decision is made on the compliance of the Subject of Medicines Circulation with the requirements of the technical regulation.

Representatives of the federal executive body, whose competence includes the implementation of state control and supervision in the field of circulation of medicines for animals, has the right:

freely on the basis of an order to gain access to any subject of medicines circulation;

withdraw samples of medicines in the amount necessary for their research in accordance with the requirements normative documentation make copies of documents related to the circulation of medicines;

prohibit or suspend the production and sale of medicines that pose a threat to human life and health, animals, and the environment;

to send for disposal identified low-quality, falsified and illegally circulated medicines on the territory of the Russian Federation.

STATE INSPECTION OF THE SAFETY AND QUALITY OF MEDICINES

The Chief State Veterinary Inspector of the Russian Federation is also the head of Rosselkhoznadzor. He is directly subordinated to deputies, heads of departments of Rosselkhoznadzor - deputy chief veterinary inspectors, chief and leading veterinarians of departments of Rosselkhoznadzor - state veterinary inspectors, as well as chief veterinary inspectors of the constituent entities of the Russian Federation - heads of departments and departments of veterinary medicine of the subjects with their subordinates - state veterinary inspectors subjects.

State veterinary inspectors carry out inspections at supervised facilities for the production, storage, manufacture (in veterinary pharmacies) and sale of veterinary drugs. The objectives, scope and frequency of inspections, the procedure for issuing relevant documents (acts, protocols, resolutions, instructions) based on their results and making decisions, as well as the procedure for implementing measures to curb identified violations of the veterinary legislation of the Russian Federation are determined by the rules, instructions, instructions and other normative documents published and approved executive bodies based on current legislation.

Depending on the specific conditions and objectives of the inspection, the following types of inspection are used: a full scheduled inspection, an abbreviated inspection, a subsequent (repeated) inspection, and a special inspection.

A full scheduled inspection provides for a total inspection of the enterprise for all existing sections of GMP, licensing provisions and requirements.

An abbreviated inspection is reduced to a selective control of a limited number of GMP requirements, which are selected by the inspector as the most characteristic indicators of the implementation of the standard in a particular production.

A subsequent (repeated) inspection is carried out to monitor the implementation of work to eliminate violations of GMP requirements identified during the previous scheduled inspection. The timing of its implementation is set in accordance with the action plan to eliminate deficiencies. The plan is submitted to the supervisory authority no later than 30 days from the date of completion of the inspection.

A special audit of the enterprise is carried out upon admission to the Rosselkhoznadzor:

reports of serious adverse reactions caused by medicines produced by the enterprise.

In addition, special inspections are appointed: at the request of other ministries and departments; as a precondition for export authorization.

During a special inspection, inspectors check: the production of an individual medicinal product or dosage form;

performance of individual technological operations (weighing, sterilization, marking, etc.);

functioning of any production system enterprises (water treatment, ventilation, etc.).

The frequency and duration of inspections are determined by the type of inspection, the size of the establishment, the purpose of the inspection, the scope of work, and the number of inspectors involved in the inspection. It can last from a few days to two weeks or more.

Inspections should be carried out on a regular schedule, preferably every year. Large companies selling a wide range of products are subject to inspection for a longer period, but within three years, as this is the duration of the license. New manufacturing enterprises should be inspected prior to their licensing, and new technical means - before their use in the technological process.

State control over the production of medicines has been established by law and their release in violation of the rules for organizing production and quality control is prohibited.

Citizens, individual entrepreneurs and legal entities guilty of violating the current law and / or technical regulations bear administrative and criminal liability in accordance with the legislation of the Russian Federation.

Harm caused to life or health of people, animals and the environment as a result of the processes of production and manufacture, storage, transportation, sale, use and disposal of medicines that do not meet the requirements established by this technical regulation is subject to compensation by a citizen, individual entrepreneur and/or legal entity that caused harm, in accordance with the legislation of the Russian Federation.

During the state inspection, the appointed experts are endowed with broad powers, which are enshrined in law. The Federal Agency for Quality Control of Medicinal Products and territorial control authorities have the right to: freely gain access to any enterprise that manufactures medicinal products, to withdraw samples of manufactured medicinal products;

make copies of the documents necessary for the control of production and quality of drugs;

to prohibit the production of drugs and the sale of already produced drugs in cases, an exhaustive list of which is contained in the rules for organizing the production and quality control of drugs.

In the daily practice of inspection control, the following evaluation criteria and measures are used that are adequate to violations:

non-compliance with the requirements of the GMP standard; deviation from the requirements of the GMP standard (critical, significant or significant, insignificant or insignificant, remarks).

During the inspection process, the inspector must make sure that before issuing a permit for the release of each batch of products for sale, the following requirements are met: the product batch meets the requirements of the relevant pharmacopoeial article, GOST, TU and license;

compliance with the principles and rules of good manufacturing practice established by the GMP standard is observed;

the main technological processes and test methods have been validated;

all necessary checks and tests were carried out, protocols and other registration records were drawn up;

before the sale of products, the supervisory authority is provided with information on changes in production and quality control in accordance with the established information system;

additional sampling, controls, tests and checks have been carried out and recorded to resolve the intended changes and deviations;

all necessary documentation regarding technological process and quality control, completed and signed (approved) by competent inspectors;

experienced and trained personnel have carried out appropriate quality audits, self-inspections and spot checks;

when forming the documentation (dossier for the series), all factors that could affect the quality were taken into account;

the head of the quality control department (QC) issued a release permit.

AT last decade almost annually in funds mass media outbreaks of dangerous diseases among people and animals, terrible disasters, wars and other emergencies are reported. In these misfortunes, both people and animals suffer. The world has not yet fully experienced the shock of the news of the so-called “mad cow disease” that has swept the European continent, and foot and mouth disease, bird flu, classical swine fever, and brucellosis are already in line. Everyone remembers terrible earthquakes and tsunamis, wars... And this list goes on and on. The damage caused by diseases, wars and natural disasters to the population and economies of the affected countries is enormous. affected by emergencies serious medical assistance is always required. Therefore, the need for medicines for both people and animals is growing in the world.

But even in ordinary peaceful life, every 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 medical support, which gives rise to a number of serious problems. There is no state in the world that could fully meet the ever-increasing need for veterinary medicine and medicine in medicines through its own production. The pharmaceutical market is based on a wide international exchange and requires the solution of a number of issues related to the certification of product quality. The tragic consequences of the use of drugs are widely known.

According to statistics, more than 100 thousand people die every year in the United States from the use of drugs, and among the causes of death - the use of drugs is three times higher than deaths from car accidents, ranking fourth after heart disease, cancer and stroke. A similar pattern is observed in other countries. In 2001, the cause of death of about a hundred people was the use of the drug Baykol by the world famous pharmaceutical company Bayer (O. E. Nifantiev, 2003). Sad statistics are updated every year.

To minimize the likelihood of negative factors, the world community and individual countries are taking strict measures. formulated General requirements to the development, registration, production and inspection control. As a result of broad international integration, there is a convergence of the level of regulatory requirements in the field of production and quality control of medicines. Hence the very responsible attitude to the inspection service, which is constantly being developed, improved and supported by international organizations.

In relation to the manufacturer, control is external ( state inspection) and internal (self-inspection). A number of organizations have been created within the framework of the World Health Organization, European Union and others international organizations to control the development, production and sale of drugs. Regulatory legal acts and interstate agreements aimed at ensuring quality control in the field of drug circulation have been established. Among them, the most important are the GLP, GCP, GMP and GPP standards.

International standards of the ISO 8402 series consider quality systems as an inseparable unity organizational structure responsibilities of the participants in the appeal, research methods, processes and resources necessary for the implementation of general leadership.

Inspection of drug manufacturers (inspection for compliance with GMP - GMP Inspection) is a mandatory procedure for controlling the production of medicines, provided for by the Rules of Good Manufacturing Practice - GMP and adopted in all countries producing medicines. It consists in confirming by examination and providing objective evidence that the specified requirements are met in in full.

Quality control of medicines is an important function of the state; it establishes uniform norms and rules for all manufacturers, taking into account the provisions agreed upon in the process of international cooperation. The pharmaceutical market is based on a wide international exchange of products. This implies the need for unity of requirements for quality systems for drug manufacturers. It should be noted the general trend of shifting emphasis from quality control of finished drugs to production control. Main principle- quality must be built into the product and controlled during the production process.

Inspection checks of manufacturers of medicines are carried out by the Department of State Control of Quality, Efficiency, Safety of Medicines and medical technology(hereinafter referred to as the department). On his behalf, inspections are carried out by the Inspectorate for the Circulation of Medicinal Products of the Scientific Center for Expertise and State Quality Control of the Ministry of Health and Social Development of Russia (NC EGCLS, hereinafter referred to as the Inspectorate) or territorial drug quality control authorities. Inspection checks of production are carried out in the following modes:

scheduled inspection (full or regular, reduced or brief);

subsequent or re-inspection;

special inspection.

It is very important to establish norms and rules for the relationship between participants in the production of medicines, including self-inspection with structures of external control of quality systems. It is necessary to clarify who and at what stage of interaction of these entities represents the interests of the parties, their powers and responsibilities. At the same time, it is important to emphasize the main thing. Control services, whether it be a state inspection or self-inspection of a private enterprise, are links in the same chain, they have one goal - quality management.

The following forms of inspections are used to control pharmaceutical production:

1. External. Within the framework of state control: through the accreditation of QCD laboratories, through the licensing authority, through domestic creditors and investors.

On the line of the customer as part of the work under contracts.

International: through international organizations, through foreign creditors and investors, under contractual agreements, under trade agreements.

2. Self-inspection: scheduled, unscheduled, quality audit, supplier audit, contract audit.

It should be emphasized that self-inspection of quality systems is considered as one of the important elements in the system of multi-level inspection control of the production of medicines.

SELF-INSPECTION AS PART OF A UNIFIED QUALITY MANAGEMENT SYSTEM

Self-inspection on pharmaceutical company is an integral part of the quality management system and should find its rightful place in the documents that define 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 directive 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-inspection is to assess the manufacturer's compliance with GMP requirements for all aspects of the technological process and quality control.

Self-inspection allows timely detection of the slightest deviations from established order and prevent critical deviations from developing, especially non-compliance with the GMP standard. It is provided as a mandatory component in the rules of good manufacturing practice in all countries. The importance of self-inspection is also confirmed by the extensive

people's experience of using it in various fields of activity, primarily requiring high quality standards or associated with increased risk. This refers to the risks associated both with the nature of the products of production, and with the danger to personnel in the production process.

Assessing self-inspection from the standpoint of quality control systems in the production of medicines, it should be considered among the most important elements of a multilevel expert system. External inspection and self-inspection are complementary elements unified system quality management. It does not matter who organizes the inspection, the state regulatory body or the administration of the enterprise. They are united by a common idea aimed at realizing the 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 has always existed as an element of general state system quality management. But it was not formalized and strictly regulated, although it was constantly implemented in the form of quality days, cross-checks, etc. its manifestations, which coincided with a sharp transition to the redistribution of property.

The new owners, due to insufficient experience in ownership and production management, 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 world economic and social community was necessary and turned out to be impossible without the harmonization of generally accepted systems, including quality control in pharmaceutical production. I had to adapt the conditions for the production of medicines to the GMP requirements accepted in all developed countries. By the way, it turned out that not only are they not afraid of inspection abroad, on the contrary, they are developing inspection control in every possible way, primarily self-inspection, which is universally established as a mandatory license requirement.

Self-inspection of quality systems is different from self-inspection in general. Inspection at enterprises producing medicines involves checking all aspects of the activity. Each service (sanitary, technical, energy, etc.) is obliged to organize inspections in its field of activity, but they are of an administrative nature. When we are talking On self-inspection, we mean inspections of those production relations, processes and procedures that directly ensure and determine the quality of manufactured medicines.

In international practice, self-inspection is provided for by the GMP standard, in Russia it is established in the form of a section of GOST R 52249-04 “Rules for the production and quality control of medicines”. The purpose of self-inspection is to assess the compliance of production with the requirements of GMP rules for all aspects of the technological process and quality control.

When the goal is achieved, the following tasks are solved in production:

total control of the technological process; quality assurance control at all stages production process, at every workplace;

involvement of all production personnel in active participation in the control of 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 result in serious consequences for the consumer, up to fatality;

instilling a sense of responsibility among staff; ensuring the continuity of generations.

Self-inspection solves the following tasks: actual control;

implementation of the educational system (self-inspection) as an element of the personnel training program.

For the self-inspection system, tasks should 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 manufacturing practice, all organizational issues for the creation of a self-inspection system should be resolved (order of the head of the enterprise, formation of the structure, development of enterprise standards, instructions, sample documents of the system, educational component in the specifics of personnel, etc.).

At the second stage, upon achieving stable operation within the framework of GMP rules, one should:

carry out continuous control of all production units and services within the framework of the quality management system through systematic self-inspections;

promptly identify the slightest deviations from the GMP rules and contribute to their prompt elimination;

organize the external audit suppliers and contractors.

One of the components of the activity of self-inspection and the function of the quality assurance department is the quality audit. The concept of "quality audit" includes an independent analysis of the production situation in all divisions and services of the enterprise without exception on the basis of self-inspection. This allows you to determine the compliance of activities and results in the field of quality with the planned activities, as well as to evaluate the effectiveness of the introduction of new technologies and their suitability for achieving the goals. Quality audit consists in the continuous monitoring and verification of the state of the object, examination and evaluation of the entire quality system or a certain part of it in order to ensure that the established requirements are strictly met.

Supplier audits include checking the premises, facilities, documentation and products supplied by the supplier to determine whether they meet specified requirements. The history of the supplier, 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 regulations for pharmaceutical ingredients and substances.

To introduce self-inspection into everyday practice, it is necessary to formalize the system, which involves the development of an organizational structure, methodology, documentation, the formation of a self-inspection group and training of the asset.

The fundamental principles of the system are: compulsory participation personnel in ensuring compliance with the rules of good practice;

assimilation by each employee of the ideology, philosophy of GMP; focus on the main thing - achieving quality through effective control at all stages of production and for all positions; total coverage of production;