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State quality control of medicines. The system of state control of the quality of drugs in Russia of drug control groups in the Russian Federation

  • The date: 29.06.2020

Ministry of Health of the Russian Federation

On approval of the procedure for implementing
state quality control of medicinal
Tools


Raised on the basis of
order of the Ministry of Health and Social Development of Russia of October 30, 2006 N 734
____________________________________________________________________

____________________________________________________________________

For clarification of this order, see the Department of State Control of Medicines and Medical Equipment on March 4, 2004 N 295-22 / 37

____________________________________________________________________

In order to strengthen state control and in accordance with the Federal Law of June 22, 1998, N 86-FZ "On Medicines" (Meeting of the Legislation of the Russian Federation, 1998, N 26, Article 3006; 2000, N 2, Article 126; 2002 , N 1 (C.I), Art.2; 2003, N 2, Article 187)

order:

1. To approve the procedure for the implementation of state control of the quality of medicines in the Russian Federation (Appendix).

2. To recognize the order of the Ministry of Health of Russia of March 25, 1994 N 53 (registered by the Ministry of Justice of Russia 20.05.94, registration N 571).

Minister
Y.Shevchenko

Registered
in the Ministry of Justice
Russian Federation
April 10, 2003,
registration N 4399.

Application. The procedure for the implementation of state control of the quality of medicines in the territory of the Russian Federation

application

Approved
order of the Ministry of Health
Russian Federation
dated April 4, 2003 N 137

I. General provisions

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;

- re-selective control of the quality of medicines;

- control of the quality of substances of plant, animal or synthetic origin, which have pharmacological activity and intended for the production of drugs (hereinafter - substances);

- Conducting 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.

II. Preliminary quality control of medicines

2.1. Preliminary quality control is subject to drugs produced by enterprises - manufacturers of drugs (hereinafter - the manufacturer) on the territory of the Russian Federation;

- for the first time produced by the manufacturer;

- first imported into the territory of the Russian Federation;

- issued by modified technology;

- issued after the interruption of the production of this drug from three years and more;

- In connection with the deterioration of their quality.

2.2. The procedure for pre-controlling the quality of drugs includes the following steps:

- the direction of the enterprise-producer in the Ministry of Health of Russia applications with a set of necessary documents;

- analysis of documents and issuance of permission to the Ministry of Health of Russia for preliminary quality control of medicines;

- selection of drug samples for the purposes of pre-control of the quality of medicines;

- direction to the examination of the quality of drugs of drug samples (Chapter VI of this Procedure);



- The adoption by the Ministry of Health of Russia decisions on the results of the examination of the quality of medicines.

2.3. To obtain a decision on the direction of preliminary quality control of medicines, the manufacturer's company sends to the Ministry of Health of Russia:

- application;

- certified in the prescribed copy of a drug registration certificate;

- certified copies of the title sheets of the State Standard of Quality and Conducted in the established procedure of the technological regulation of the production of drugs in the prescribed manner;

- a copy of the certificate of control laboratories of the quality control department (hereinafter - the OCC) of the manufacturer's enterprises for technical competence in the quality of the quality control of produced drugs issued in the prescribed manner of the Ministry of Health of Russia.

2.4. The decision on the preliminary control direction is issued by the Ministry of Health of Russia within 20 working days from the date of receipt of the application and the documents provided for in paragraph 2.3 of this Procedure.

2.5. Enterprises-manufacturers for the first time beginner serial release of the drug should be directed to preliminary control of the quality of medicines. Samples of the first three industrial series of this drug as they are developed.

During the decision of the Ministry of Health of Russia, the preliminary control of the quality of the medicinal product due to the deterioration of its quality control is subject to the first regular series of drugs.

2.6. Empodes-manufacturers carrying out the packaging or packaging of drugs produced by other manufacturing enterprises (domestic or foreign) should be sent to preliminary control of the quality of drugs. Samples of three industrial series of packed or packaged drug.

2.7. When changing the name of the drug, the manufacturer's enterprise sends to preliminary control of the quality of drugs one series of renamed drug.

2.8. The examination of the quality of the drug is carried out in a period not exceeding 30 working days from the date of receipt of the drug samples and the document set, if the state quality standard does not provide for quality control methods that require longer periods of performance of the quality of this medicinal product.

2.9. At the end of the examination of the quality of the medicinal product, results with the analysis protocol are sent to the Ministry of Health of Russia and the manufacturer's enterprise.

2.10. The drug is removed from pre-control of the quality of medicines and is translated to selective control of the quality of medicines by the decision of the Ministry of Health of Russia, if the quality of all the presented drug samples complies with the requirements of the state standard of the quality of this medicinal product.

Based on the decision of the Ministry of Health of Russia on the removal of the drug with preliminary quality control of drugs, as well as the results of the examination of the effectiveness and safety of the drug, the manufacturer of the Ministry of Health of Russia is issued a decision on the release of the drug in the sphere of drug treatment on the territory of the Russian Federation on the results of state control Quality, efficiency, drug safety. This decision is the basis for the issuance of the enterprise-producer of the Ministry of Health of the Russian Federation on the conformity of the organization of the medicinal product manufacturing by the manufacturer of the Federal Law "On Medicines".

2.11. If there are comments to the quality of the medicinal product based on the results of the examination of the quality of this drug, it is not subject to removal from pre-control. The number of a series of drug directed by the manufacturer to re-preliminary control by the enterprise is determined by the Ministry of Health of Russia on the basis of the results of the examination of the quality of the drug.

III. Selective quality control of medicines

3.1. Selective control of the quality of drugs is subject to drugs of domestic and foreign production, which are in the field of drug circulation in the Russian Federation.

The nomenclature and frequency of selection of drug samples on selective control of the quality of drugs are governed by the sample control plan, which is approved in the prescribed manner and is communicated to enterprises - drug manufacturers in the form of assignment plans.

During the calendar year, the task plan can be adjusted taking into account the change in the nomenclature of drugs in the field of circulation in the Russian Federation, or the identified non-compliance of their quality with the requirements of state quality standards of medicines.

3.2. The procedure for selective quality control of medicines includes the following steps:

- the adoption of the Ministry of Health of Russia decisions on the conduct of selective control of the quality of medicines in accordance with the approved plan of selective quality control of medicines;

- Selection of drug samples for the purposes of selective quality control of medicines;



- carrying out the quality examination of the presented samples of medicines;

- Adoption by the Ministry of Health of Russia Decisions on the results of the examination of the quality of the drug.

3.3. The examination of the quality of the drug is carried out on time not exceeding 40 working days from the date of receipt of the drug samples and the document set, if the state quality control methods do not provide for quality control methods that require longer rules.

3.4. The results of the examination of the quality of the drug in the framework of the sample quality control of medicines are sent to the Ministry of Health of Russia and the manufacturer's enterprise.

3.5. When detecting a non-compliance with the quality of the medicinal product of the manufacturer, the requirements of the State Standard of Quality, the Ministry of Health of the Russian Federation sends information about the seizure of the party of poor-quality drug into the territorial controls of the quality of medicines.

After receiving information from the Ministry of Health of Russia on the identified party of poor-quality drug, the territorial body of quality control body, on the territory of which the party of the poor-quality drug was found, is obliged to take measures to identify and withdraw from the treatment of a poor-quality drug in the subordinate territory of the constituent entity of the Russian Federation. The withdrawal and destruction of poor-quality drugs are carried out by the executive authority of the constituent entity of the Russian Federation in the manner prescribed by the current legislation of the Russian Federation. Information on the identified number of poor-quality drugs and adopted measures for its withdrawal and destruction is sent to the Ministry of Health of Russia.

3.6. The territorial controls of quality control bodies in the territory of which other parties of the poor-quality series of the drug are obliged to take measures to conduct the quality of this medicinal product. Information on the results of such an inspection is sent to the Ministry of Health of Russia.

3.7. Selective control of the quality of certified drugs in the field of drug circulation in the territory of the Russian Federation, upon admission to their place of destination, is carried out by territorial controls of quality control within the framework of inspection control of the quality of medicines.

3.8. During the inspection audit of the quality of certified drugs in the field of appealing on the territory of the relevant constituent entities of the Russian Federation, selective quality control is conducted in terms of "Description", "Packaging", "Marking", the origin, the compliance of the drug documentation and the State Quality Standard, belonging to This batch of drugs.

3.9. Samples of certified drugs for the purposes of selective control are selected by the specialists of the Ministry of Health of Russia, authorized by the Ministry of Health of Russia, the expert body or the territorial body control body.

3.10. If doubts occur in the accuracy of the data obtained as a result of checking the accompanying documentation and quality control of the drug in terms of "Description", "Packaging", "Marking" may be carried out additional tests. The choice of the volume of tests for the sample verification of the quality of drugs, allowing to fully and reliably confirm the compliance of drugs with the requirements established by state quality standards, in each particular case is determined by the territorial body quality control body.

3.11. The territorial body quality control body represents information about cases of identifying the quality of medicines to the requirements of the state, illegal copies, or fakes registered in the Russian Federation of medicines, and also sends a monthly report on the results of certified drug quality inspections.

IV. Re-selective quality control of medicines

4.1. Drugs are subject to repeated selective control of the quality of medicines in the event of disputes about their quality between the subjects of drug circulation.

4.2. Repeated selective quality control of medicines is carried out by the decision of the Ministry of Health of Russia.

4.3. The procedure for repeated selective quality control of medicines includes the following steps:

- the direction of the manufacturer in the Ministry of Health of Russia of Russia for repeated selective control of the quality of the medicinal product and the necessary documents with the rationale for its implementation;

- consideration by the Ministry of Health of Russia of the submitted documents and the decision to conduct a re-selective control of the quality of drugs;

- selection of drug samples for the purposes of re-selective quality control of medicines;

- direction to the examination of the quality of drugs of drug samples in accordance with the head of VI of this Procedure;

- carrying out the quality examination of the presented samples of medicines;

- The adoption of the Ministry of Health of Russia decisions on the presented results of the examination of the quality of the medicinal product.

4.4. On repeated selective control of the quality of drugs, drugs can be sent by a participant in the treatment of medicines that revealed non-compliance with the requirements of state-owned quality standards, and a manufacturer's enterprise that directs the archival samples of this drug to repeatedly selectively control.

4.5. The decision to conduct a re-selective quality control of the drug is made by the Ministry of Health of Russia within 20 working days from the date of receipt of the application and the documents provided for in paragraph 4.3 of this Procedure.

4.6. Medicinal quality examination For re-selective quality control purposes, no more than 20 working days from the date of receipt of the drug samples and a set of documents, if the state quality standard does not provide for control methods that require longer rules.

4.7. The results of the analysis of the quality of the drug with the analysis protocol are sent to the Ministry of Health of Russia and the subjects of the treatment of medicines that submitted a drug samples for repeated selective control of the quality of medicines.

V. Quality control of vegetable, animal, microbial or synthetic origin, which have pharmacological activity and intended for the production of drugs

5.1. State control of the quality of substances of vegetable, animal, microbial or synthetic origin, which have pharmacological activity and intended for the production of drugs (hereinafter - substances), is carried out at the stage of their registration, as well as within the framework of preliminary and selective control of their quality as medicines based on the decision Ministry of Health of Russia in accordance with the chapters II and III of this Procedure.

5.2. All substances at the stage of their registration are subject to quality examination, as well as substances imported into the territory of the Russian Federation and intended for the manufacture of medicines.

5.3. Examination of the quality of substances is carried out within a period of no more than 30 working days from the date of obtaining samples of substance and standard samples of the substances necessary for conducting quality examination, if there are no control methods in the state quality standard, requiring longer periods of their implementation.

Vi. The order of selection, direction and storage of drug samples for the implementation of state quality control of medicines

6.1. The procedure for selecting drug samples

6.1.1. Drug samples for the preliminary, selective and repeated selective quality control of medicines are selected by the specialists of the Ministry of Health of Russia and (or) institutions that are members of the quality system of quality control, efficiency, drug safety, on the basis of the decision of the Ministry of Health of Russia.

Sampling of domestic drugs for preliminary and selective quality control of medicines is carried out with the participation of representatives of the quality control department of the re-selective control of the quality of drugs - from archival samples of drugs of the manufacturer's OCC. Selection of drug samples on selective quality control of medicines can also be carried out when checking the manufacturer's enterprise in order to inspect the quality of medicines.

Sampling of foreign drugs on selective quality control of medicines is carried out from warehouses in the Russian Federation, indicated by a foreign enterprise-producer.

6.1.2. The Ministry of Health of Russia may transmit authority to select drug samples by territorial body quality control bodies.

6.1.3. The entity of the treatment of medicines in the Russian Federation, which revealed the discrepancy between drugs with the requirements of the state standard of quality, is to repeatedly selectively control the quality of drugs, the samples of an inappropriate drug in an amount sufficient to analyze the analysis under the test indicator and authentication indicator.

6.2. Procedure for the direction of drug samples on state control of the quality of medicines

6.2.1. Drug samples are sent to state control of the quality of medicines in the package provided for by the State Quality Standard; Samples of substances - in glass containers. Marking of drug samples must comply with the requirements of state quality standards.

6.2.2. To preliminary and selective control of the quality of drugs and the quality control of the substance at the registration stage, the drug samples are sent in an amount sufficient to carry out three analyzes in accordance with the requirements of the State Drug Quality Standard (taking into account the test for microbiological purity).

Samples of drugs for injection and eye drops are sent taking into account the tests of the indicator "Mechanical inclusions", and samples of medicinal vegetation raw materials - taking into account the results of radiation control.

6.2.3. Samples of drugs sent to preliminary or selective quality control of medicines, as well as samples of substances should be accompanied by standard samples of substances and substances necessary for monitoring in accordance with government quality standards.

6.2.4. Drug samples for pre-control of the quality of drugs are sent along with the sample substance from which they are made. Samples of substances are sent in an amount sufficient to conduct two analyzes in accordance with the approved state standard of quality.

On selective control of the quality of drugs, the samples of domestic drugs are sent with an archival model of a substance in an amount sufficient to conduct two analyzes in accordance with the approved state standard of quality.

6.2.5. On repeated selective control of the quality of medicines, the manufacturer's enterprise sends samples of drugs in undisturbed packaging. The number of packages components of the sample is calculated by the formula: 0.4, where N is the number of packages in one series, but not more than 30 packages.

The number of drug samples sent to repeated selective control of the quality of the drug in terms of "Mechanical inclusions" and "radiation control" indicators is determined by the relevant state quality standards.

6.3. Accompanying documents

6.3.1. Drug samples are sent to state control of the quality of medicines with a cover letter, which indicates the type of quality control of drugs, with a certificate of quality of the medicinal product of the manufacturer and the act of sampling of medicines.

Drug samples directed to selective or repeatedly selectively control the quality of drugs should be accompanied by a certified copy of the certificate of the drug conformity with the analysis protocol.

Samples of substances for conducting quality examination for the purpose of registration of the drug are sent to the accompanying letter, which indicates the type of quality control of medicines, and the quality certificate of the manufacturer's medicine.

6.3.2. Samples of drugs for injection and eye drops, sent to pre-control of the quality of drugs, except for the documents listed in paragraph 2.3.1 of this Procedure, must be accompanied by the results of testing the quality of these drugs in terms of "mechanical inclusions". The results of such an inspection represent the territorial controls of the quality of drug quality.

6.3.3. Samples of substances that produced drugs submitted to the preliminary and selective quality control of medicines (for domestic producers) should be accompanied by a certificate of quality issued on the results of the quality control of the substance in its production at the manufacturing enterprise for all indicators of the regulatory document, original or certified copy of the quality certificate of the manufacturer's medicine; For foreign substances, the dates of manufacture and expiration date of the substance should be additionally indicated.

6.3.4. Standard substance samples submitted in accordance with paragraph 2.2.3 of this Procedure must be accompanied by an original or certified copy of the quality certificate of the manufacturer's medicine.

6.4. Storage of drug samples

Drug samples remaining after state control of the quality of medicines are stored at least 6 months, after which the samples of drugs that do not meet the requirements of the state standard of quality are to be destroyed in the prescribed manner. Drug samples that meet the requirements of state standards of quality are returned to manufacturers to enterprises for their written request or are used in research purposes or donated to health care institutions for their written applications.

Appendix 1. Decision on the release of drugs

Attachment 1
to the procedure for implementation
state control
quality of medicines
in the territory of the Russian Federation

Approve
head of department
state control
medicines,
medical products
appointments and medical equipment
Ministry of Health of Russia
________________ (FULL NAME.)
"__" _____ 200__

DECISION
on the release of medicines

______________________________________
business name

Legal address: ________________________ Tel .___ Fax ____ E-Mail ___________

Manufacturer's address: ________________________________________________________

The contact person: __________________________________________________________

Nim-
drugs
fundaver

Drugs
vidnaya form

Dosage
rank

Primary
naya Up
forging

If-
in the primary
noah packaging

Cons-
tel packaging

Registra
ration
number

States
quality standard (standard
document)


Leader of the enterprise __________________ Signature ______________ Print

The Ministry of Health of the Russian Federation confirms that these drugs have passed the procedure of state quality control, efficiency, security, and can be resolved (name of the enterprise) to issue drug addiction in the Russian Federation.

Deputy Head of Department

Appendix 2. Act of the Selection of Drug Samples

Appendix 2.

to the procedure for implementation
state control
quality of medicines
in the territory of the Russian Federation

from "__" __________ ____

Commission composed:

(surname, name, patronymic, position)

made seizures of medicines from a warehouse

(full name)

Name of the drug

Total Drug Party

Number of selected drug samples

Note

Specialist (position) of the Ministry of Health of Russia (expert body, territorial body quality control body)

(signature)

Representative of the OCC of the manufacturer

(signature)

The text of the document is drilled by:
Bulletin of regulatory acts
federal organs
executive power,
N 29, 21.07.2003


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Currently, an international fund for the study of the safety of medicines has been established. It provides advice and material support in testing new drugs, seeking to bring these tests to the level of international requirements. Medicinal quality control is carried out at several levels: federal, regional, territorial and at the pharmacy level.

On federal level Educated Controlaccording to standardization and quality control of medicines and medical equipment in 1992.

In the introduction of management are:

1. Russian State Medicinal Examination Center;

2. All-Russian Research Institute of Medical Technology;

3. State Research Institute for Standardization and Quality Control of Drugs (GNIIscalls);

4. Bureau for registration of new medicines and medical equipment;

5. All-Russian Scientific Center of Biologically Activities (BAV).

Office coordinates activity:

1. Pharmacological State Committee;

2. Pharmacopoeia State Committee;

3. Committee on Medical Immunobiological Preparations;

4. Committee on new medical equipment.

Management tasks:

1. Organization and implementation of quality control of domestic and foreign medicines and medical equipment;

2. Organization of research and development on quality control of medicines, standardization and certification;

3. Examination of draft regulatory documents (ND);

4. Organization of publication of the GF.

Control functions:

1. Systematic revision of the nomenclature of funds allowed for use in medical practice;

2. issuing certificates for export;

3. Maintaining state registers of domestic and foreign medicines and medical equipment products.

4. Analysis of information on the side effects of medicines and the adoption of measures to eliminate it.

Russian State Expertization Center Performs expert functions on preclinical and clinical trials, including an assessment of the test results. It has a pharmaceutical examination department for checking the quality of the presented drug samples with ND requirements and reproducibility of analysis techniques.

Pharmacological Committee. - This is the expert body of the Ministry of Health of the Russian Federation on clinical trial and application in the medical practice of medicinal, diagnostic and preventive agents. The Committee employs several specialized expert commissions.

Functionspharmacological Committee:

1. It evaluates the specific activity and safety of domestic and foreign medicines that do not have permission to medical use;



2. conducts examination of materials on preclinical testing;

3. Allows the tests of new drugs;

4. Determines the scope and nature of clinical studies in accordance with the Rules of GCR, adapted to domestic clinics;

5. Solves the feasibility of the use of new medicines in medical practice;

6. Revises the nomenclature of medicines to exclude the registry.

Pharmacopoeia committee - This is the organ of state standardization of medicines. It also includes several specialized expert commissions.

Functions Pharmacopoeia Committee:

1. Prepares for the publication of the Russian Federation of the Russian Federation;

2. Conducts an expertise of the FS for new drugs;

3. Systematically revises the FS;

4. Makes lists of shelf life on domestic and foreign drugs;

5. Conducts examination of guests to contain packaging, packaging, etc.;

6. Conducts examination of ND on foreign drugs used in the Russian Federation.

Compliance with manufacturers and consumers of pharmaceutical products and products of medical equipment of standards, regulations, ND at the federal level controls State inspection on controlling the quality of medicines and products of medical equipment.

At the regional level Problems of creating effective, safe and high-quality drugs decide regional expertise centers(for example, in Nizhny Novgorod).

In the territorial level Quality control is carried out quality control centers (CCC) on "Pharmacy", which should have accreditation to this type of activity. Their activities are coordinated by the Pharmacy Office at MW.

The CCC performs the following activities:

1. Production is to control the quality of medicines made in pharmacy institutions and entered the pharmacy store;

2. Organizational-methodical is the management of the control and analytical service of pharmacy institutions;

3. Control and Advisory - this is the consultation of pharmacy workers on the preparation, storage and vacation of pharmacy products;

4. Research is a study of a frequently found formulation, the development of new analysis techniques, etc.

The final link of the State Medicinal Quality Control System is inportal controlperformed at the pharmacy level. The basic principles and types of in-service monitoring are set out in order 214 of 1997.

Main directions Air-scale control:

1. Preventive measures;

2. Evaluation of the quality of medicines prepared in a pharmacy using all types of control (questionnaire, physical, chemical, etc.)

Quality control of medicines prepared in a pharmacy is carried out on the territory of the pharmacy. For this, a control and analytical study or table is organized. Medicinal analysis performs a provisional analyst.

The results are fixed in the magazines of the established form. Annual report is sent to the CCC.

All the above mentioned organizations and departments are designed to exclude the possibility of use in medicine drugs that can have a toxic or disastrous effect on a person.

In addition, in accordance with the Federal Law "On Certification of Products and Services", drugs are subject to mandatory certification. All-Russian certificate Compliance is issued by the inspection of state control of the quality of medicines based on the conclusion of the GNIIscolls (see above).

At industrial enterprisesproducing pharmaceutical products supervision of its quality assigned to technological Control Department (OPC) - This is an independent structural division of the enterprise. The head of the SIL reports the director and on a par with him is responsible for product quality. Employees SIL are subject to the boss receiver and independent of workshops and other departments.

Functions Rev:

1. Control of raw materials and semi-finished products;

2. Primary control (postal control, acceptance of finished products);

3. Selective control (subsequent series selectively);

4. Control over the state of measuring instruments;

5. Control over compliance with production technology;

6. Registration of documentation for products and complaint documents on raw materials and semi-finished products.

State control (supervision) in the field is one of the species provided for in Article 85 Federal Law of 21.11.2011 No. 323-FZ "On the basis of the health of citizens' health in the Russian Federation" (hereinafter referred to as Federal Law No. 323-FZ).

In accordance with "On the circulation of medicines" (hereinafter referred to as Federal Law No. 61-FZ) State control (supervision) in the field of drug circulation includes:

  • in the production of drugs and pharmaceutical activities;
  • Federal State Supervision in the field of drug circulation.

Federal Law No. 61-FZ extends, including the appeal of narcotic drugs and psychotropic drugs, as well as the appeal of radiopharmaceutical drugs, taking into account the characteristics established by the legislation of the Russian Federation.

In accordance with Federal Law No. 61-FZ Licensed control in the production of medicines and in the field of pharmaceutical activity is carried out by the "authorized federal executive authority and the executive authorities of the constituent entities of the Russian Federation according to their competence."

Attention should be paid for some differences In these two types of licensed control:

  • First, licensed control in the production of drugs and licensed control in the field of pharmaceutical activities in view of differences in the subject is two different types of licensed control;
  • Secondly, licensed control in the production of medicines refers to the competence of federal executive bodies and is not carried out by the executive authorities of the constituent entities of the Russian Federation;
  • Thirdly, licensed control in the production of drugs and licensed control in the field of pharmaceutical activity is not alone, but several authorized federal executive bodies.

On the subjects authorized to conduct license control within FZ No. 61

From October 3, 2016, the main license control in relation to organizations (licensees), with the exception of licensed control over licensees that submitted statements on the re-issuance of licenses is carried out. Such powers of Roszdravnadzor were submitted on the basis of the Federal Law of 05.04.2016 No. 93-FZ.

In addition, the proposed regulatory legal act, Roszdravnadzor authorities are also authorized to suspend, resume action and cancellation of licenses, monitoring the effectiveness of licensing activities.

Roszdravnadzor's unplanned audits have begun from October 2016.

Powers to schedule compliance with licensing requirements of Roszdravnadzor authorities are carried out from January 2017 (a letter of Roszdravnadzor from 11/03/2016 No. 02I-2155/16 "On Compliance with the Legislation").

In turn, the executive authorities of the constituent entities of the Russian Federation (for example, the Ministry of Health of the Moscow Region) are carried out with the above date only license control regarding license applicants and licensees that submitted statements about reissuing licenses.

Licensed control in the production of medicines and in the field of pharmaceutical activity is carried out in the manner prescribed Federal Law of December 26, 2008 No. 294-FZ "On the protection of the rights of legal entities and individual entrepreneurs in the implementation of state control (supervision) and municipal control" (hereinafter referred to as Federal Law No. 294-FZ), taking into account the characteristics of the organization and conducting inspections established by Federal Law of May 4, 2011 No. 99-FZ "On the licensing of certain types of activities" (hereinafter referred to as Federal Law No. 99-FZ).

Licensing requirements for license applicants and licensees in the production of drugs and pharmaceutical activities

As part of the license control, the execution of a license applicant is checked or a licensee of licensing requirements in the field of drug production and (or) in pharmaceutical activity. Such license requirements are established according to the Regulations on the licensing of drug production, approved. Decree of the Government of the Russian Federation of 06.07.2012 No. 686, and the Regulations on the Licensing of Pharmaceutical Activities, UTV. Decree of the Government of the Russian Federation of 12/22/2011 No. 1081.

It should be noted that a number of licensed requirements provided for in these regulatory legal acts coincident. For example, such requirements for applicants and licensees are coincided as the availability of a license to carry out medical activities, the presence of premises and equipment belonging to the right of ownership or other legitimate grounds necessary for work (services). However, the differences in the established licensed requirements can be distinguished.

Thus, licensed requirements in the production of drugs not related to licensed requirements in the field of pharmaceutical activities include compliance in accordance with Article 45 of the Federal Law No. 61-FZ of industrial regulations, compliance with the rules for organizing production and quality control of medicines, compliance with the requirements On the prohibition of drug production, not included in the state register of medicines etc. Exceptional license requirements in the field of pharmaceutical activities are the requirements for pharmaceutical education and the work of the work of managers and employees of the organization, compliance with the rules of the wholesale trade of drugs for medical applications, regulations for registration of operations related to the appeal of medicines for medical use, etc.

The procedure for the implementation of licensing control in the field of drug production and in the field of pharmaceutical activity is partially regulated by administrative regulations. Accepted such administrative regulations like:

  • Administrative regulations of the Rosselkhoznadzor for the provision of public services for licensing medicines for veterinary use, applying. Order of the Ministry of Agriculture of Russia from 28.03.2016 No. 98;
  • Administrative regulations of the Rosselkhoznadzor for the provision of a state service for licensing pharmaceutical activities carried out in the field of treatment of medicines for veterinary use, ultrasound. Order of the Ministry of Agriculture of Russia of 01.03.2016 No. 80;
  • The administrative regulations of the Roszdravnadzor for the provision of state services for licensing pharmaceutical activities carried out by the wholesale trade in medicines for medical applications and pharmacy organizations subordinate to the federal executive bodies, State Academy of Sciences, "approved. Order of the Ministry of Health of Russia of 03/25/2014 No. 130n;
  • Administrative regulations by the Ministry of Industry and Commission on the provision of public services for licensing medicines for medical use, utensils. Order of the Ministry of Industry and Commission of Russia of 07.06.2013 No. 877.

Federal State Supervision in the field of drug treatment (hereinafter - supervision in the field of drug circulation) in accordance with Part 4 of Art. 9 federal law of 12.04.2010 No. 61-FZ includes six main directions.

  • The first direction of supervision in the field of drug circulation includes the organization and conduct of the inspection of compliance with the subjects of drug treatment of established requirements for:
    • Preclinical research of medicines;
    • Clinical studies of drugs;
    • Storage of medicinal preparations, as well as to transportation, import to the Russian Federation, holiday, sales of medicines;
    • Use of drugs;
  • The second direction of supervision in the field of drug circulation includes the organization and conduct of the compliance with authorized executive authorities of the constituent entities of the Russian Federation, the methodology for establishing the limiting size of wholesale premises and the limit sizes of retail premises to the actual selling prices established by drug producers, drugs included in the list of vital Necessary and most important drugs (hereinafter referred to as the methodology for establishing limit sizes).
  • The third direction of supervision in the field of drug circulation is the organization and conducting inspections of the compliance of drugs in circulation, established by the required requirements for their quality.
  • The fourth direction is associated with the use of measures to curb the violations of mandatory requirements and (or) eliminate the consequences of such violations, the issuance of compulsory demands and attracting persons who have committed such violations.
  • The fifth direction is.
  • Sixth direction - organization and conduct.

The competence of the executive authorities in the framework of supervision in the field of treatment of medicines, the order, in the framework of this type of supervision, as well as the basic rights of officials are enshrined in the Regulations on the Federal State Supervision in the field of drug circulation approved Decree of the Government of the Russian Federation of October 15, 2012 No. 1043 (hereinafter referred to as the Decree of the Government of the Russian Federation No. 1043).

Supervision in the field of drug circulation carried out by authorized federal bodies executive power:

  • In relation to medicines for medical use, with the exception of the organization and conduct of inspections by the authorized executive authorities of the subjects of the Russian Federation, the methodology, the establishment of limit sizes - Roszdravnadzor and its territorial bodies;
  • With respect to medicines for veterinary use - Rosselkhoznadzor and its territorial bodies;
  • Regarding the organization and conduct of inspections by the authorized executive authorities of the constituent entities of the Russian Federation, the methodology for establishing limit sizes - the federal service for tariffs in the implementation of federal state control (supervision) in the field of price regulated by the state (tariffs).

It is worth noting that the last authority was previously carried out by Roszdravnadzor, and was transferred to the Federal Service for Tariffs in June 2013 after entering into force Decisions of the Government of the Russian Federation of 05.06.2013 № 476 "On issues of state control (supervision) and recognition of the increasing strength of some acts of the Government of the Russian Federation".

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The frequency of exercise of supervision in the field of drug circulation

The frequency of supervision in the field of drug circulation is determined in the Decree of the Government of the Russian Federation of 11/23/2009 No. 944 in accordance with which scheduled inspections can be carried out once in one or two years. It should be paid to the fact that the Decree of the Government of the Russian Federation of November 23, 2009 No. 944 establishes the requirements for checks only defined activities (for example, retail trade in drugs and making medicines in pharmacy institutions, wholesale trade in medicines) conducted by authorities carrying out licensing pharmaceutical activities.

In all other cases, supervision in the field of drug circulation from August 11, 2017 is carried out using a risk-oriented approach (part 2 of Article 8.1 of Federal Law No. 294-FZ). This means that planned checks within this type of control are carried out with a frequency depending on the risk category established by the rules of the Government of the Russian Federation of July 31, 2017 No. 907. In total, 4 categories of risk are established for the subjects of drug circulation subjects; depending on this, way:

  • 1 time in 3 years - for the category of significant risk;
  • Not more than 1 time in 5 years - for the category of medium risk;
  • Not more than 1 time in 6 years - for the category of moderate risk;

If the organization's activities are assigned to the low-risk category, then planned checks are not conducted at all.

The supervision in the field of drug circulation is carried out through the scheduled and, and in accordance with the provisions of the Federal Law No. 294-FZ.

Terms and sequence of administrative procedures in the implementation of supervision are set administrative regulationsDeveloped and approved in accordance with the Decree of the Government of the Russian Federation of May 16, 2011 No. 373 "On the development and approval of administrative regulations for the execution of state functions and administrative regulations for the provision of public services".

To date, not all administrative regulations on the implementation of inspections under the supervision of drug circulation are approved. Nevertheless, some directions of supervision still regulated, for example:

  • Medicinal circulation supervision through the organization and conduct of inspections of compliance with the subjects of drug circulation requirements for preclinical research of drugs, clinical studies of drugs, storage, transportation, vacation, drug sales, the use of drugs, the destruction of drugs is regulated by the administrative regulations of Roszdravnadzor execution of the state function to implement the relevant federal state supervision, utensils. Order of the Ministry of Health of Russia dated December 26, 2016 No. 998n;
  • Supervision in the field of drug circulation through the organization and conduct of inspections of the compliance of drugs for medical applications in civil circulation, established requirements for their quality is governed by the administrative regulations of Roszdravnadzor on the execution of the state function to implement the relevant federal state supervision. Order of the Ministry of Health of Russia of December 26, 2016 No. 999n;
  • Supervision in the field of treatment of medicines for veterinary use is governed by the administrative regulations for the execution of the Rosselkhoznadzor of the state function to implement the federal state supervision in the field of drug treatment for veterinary applications, apply. Order of the Ministry of Agriculture of Russia of March 26, 2013 No. 149;
  • Etc.

In the Decree of the Government of the Russian Federation No. 1043, the focus was on the areas of supervision in the field of drug circulation, which directly associated with checks. Thus, such not directly related to the verification of the direction, as issuing permits for the importation of drugs into the territory of the Russian Federation, as well as the organization and monitoring of the safety of drugs have a certain specificity.

About verification sheets

From January 1, 2018, scheduled inspections within the federal state supervision in the field of drug circulation are carried out by Roszdravnadzor using verification sheets (list of control issues) (PP of the Russian Federation of July 14, 2017 No. 840). To date, within the framework of this type of control, on the basis of the order of Roszdravnadzor of 09.11.2017 No. 9438, 39 forms of verification sheets were approved (list of control issues) in the following components of drug circulation, depending on the type and type of medical and pharmaceutical organizations:

  • storage of medicinal drugs for medical use;
  • transportation of medicines for medical use;
  • vacation and sale of drugs for medical use;
  • implementation of medicines for medical use;
  • the destruction of medicinal drugs for medical use;
  • compliance with the requirements for conducting preclinical research of medicines;
  • compliance with the requirements for clinical studies of medicines;
  • compliance with the quality of medicines.

According to the sense of the legislator, verification sheets include lists of the issues, the answers to which clearly indicate the observance or non-compliance with the organization of mandatory requirements that make up the subject of verification. Moreover, the subject of the planned check should be strictly limited to the list of issues that are included in the checklist data.

Issuance of drug importance permits to the territory of the Russian Federation

Issuance of drug importance permits to the territory of the Russian Federation (hereinafter - the issuance of permits) is carried out in accordance with Federal Law of 12.04.2010 No. 61-FZ, as well as federal law of July 27, 2010 No. 210-FZ "On the organization of the provision of state and municipal services".

The rules for the importation of medicines for medical applications to the territory of the Russian Federation approved Decree of the Government of the Russian Federation of 09/29/2010 No. 771.

It should be noted that these rules do not apply to import narcotic drugs, psychotropic substances And their precursors, in respect of which the Decree of the Government of the Russian Federation of 21.03.2011 No. 181 "On the procedure for entering into the Russian Federation and export from the Russian Federation of narcotic drugs, psychotropic substances and their precursors".

The terms and sequence of actions for issuing permits are established in the administrative regulations of the Ministry of Health of the Russian Federation on the provision of a state service for issuing permits to import into the territory of the Russian Federation of a particular party registered and (or) unregistered drugs intended for conducting clinical studies of drugs, a specific batch of unregistered drugs intended for the examination of drugs in order to implement the state registration of drugs, a particular batch of unregistered drugs to provide a particular testimony of a particular patient. Order of the Ministry of Health of the Russian Federation of 02.08.2012 No. 58n.

Chapter 13 of the Federal Law of 12.04.2010 No. 61-FZ is devoted to monitoring the safety of drugs.

carried out by authorized federal executive authorities:
  • The authority authorized to monitor the safety of drugs for medical use is Roszdravnadzor;
  • The authority authorized to monitor the safety of drugs for veterinary use is, Rosselkhoznadzor.

Drug treatment entities are obliged to report to authorized bodies all cases of side effectsnot specified in the instructions for the use of the drug, about serious unwanted reactions, unforeseen unwanted reactions when using drugs, on the peculiarities of the interaction of drugs with other drugs that were identified during clinical studies and the use of drugs.

Roszdravnadzor or Rosselkhoznadzor based on monitoring results may decide on the suspension of the use of the drug.

The procedure for suspension of the use of the drug for medical use is approved by order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 No. 758n.

Until April 1, 2017, the procedure for the interaction of the subjects of drug treatment and authorized bodies during the monitoring of the safety of medicines was established in the following regulatory legal acts:

  • In the exercise of monitoring the safety of drugs for medical use, registration of side effects, serious unwanted reactions, unforeseen unwanted reactions when using medication for medical use, applying. Order of the Ministry of Health and Social Development of the Russian Federation of 26.08.2010 No. 757n;
  • In the implementation of monitoring the safety of drugs for veterinary use, registration of side effects, serious undesirable reactions, unforeseen unwanted reactions when using drugs for veterinary use and providing information about it, approved. Order of the Ministry of Agriculture of the Russian Federation of 10.10.2011 No. 357.

From April 1, 2017, the procedure for the implementation of the pharmaconadzor, approved by order of Roszdravnadzor, approved by order No. 1071 (hereinafter referred to as Order No. 1071).

Recall that the pharmaconadzor is a type of activity on monitoring the effectiveness and safety of drugs, aimed at identifying, evaluating and preventing the undesirable effects of drugs.

Approval of Procedure No. 1071 introduced the regulation of the rules for the direction of medical organizations to notice the unwanted reaction or the absence of therapeutic effect of the drug, as well as the form of such notification and terms and procedure for its direction in Roszdravnadzor.

You can read detailed information about the pharmaconadzor and duties of a medical organization as part of its implementation in the article of the Faculty of Medical Law ".

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Ministry of Health of the Russian Federation

GBOU VPO St. Petersburg Chemical and Pharmaceutical Academy

Pharmaceutical technical school

Specialty 330201 "Pharmacy"

PM 01. Realization of drugs and pharmacy assortment goods.

MDC 01.02. Vacation of medicines and pharmacy assortment goods

COURSE WORK

"The system of state quality control of medicines"

students III course group №261

Mammoth Elizabeth Stanislavovna

Head of the work of Oreshkova Tatyana Aleksandrovna

Introduction

GMP rules

Preliminary quality control of medicines

Selective quality control of medicines

Re-selective control of qualitarious means

Quality control of substances with pharmacological activity and intended for the production of drugs

Order of the selection, direction and storage of drug samples for the implementation of state quality control of medicines

Conclusion

List of references

Introduction

control Quality Medicine

I became interested in this topic because I think that the buyer, who I and I, too, has the right to receive only proven and high-quality products, and especially medications. I am interested in more details to reveal the stages of state control and be competent in this area.

What is the quality? Quality is the characteristics of the object that satisfy the needs of consumers in our case. But if in the sphere of food industry or clothing infrastructures, the buyer can evaluate the quality itself, in the drug industry, it cannot do this, so the assistance of authorized bodies is required. To assess the technical level of the production and quality of medicines, the World Health Organization was created by the "System of Quality Certificate of Pharmaceutical Drugs in International Trade", which currently actually adopted in 1992

To participate in the system, it is necessary to have the presence of three conditions in the country:

State registration of medicines;

Regular state inspection of pharmaceutical enterprises;

Compliance of current production requirements of GMP rules

In the Russian Federation, state control is carried out by the Federal Health Supervision Service (Roszdravnadzor).

Decree of the Government of the Russian Federation of 30.06.2004 No. 323 "On approval of the Regulation on the Federal Service for Supervision of Health" (clause 5.1.4.2.) In Roszdravnadzor, authority is entrusted to federal state supervision in the field of drug circulation through conducting drug conformity checks Mandatory requirements for their quality.

All drugs manufactured in the Russian Federation are subject to verification, as well as imported from other countries. Control over the fullness and quality of the implementation of state supervision includes conducting inspections, identifying and eliminating applicants 'rights violations, the use of measures to curb the violations of mandatory requirements and eliminating the consequences of such violations, consideration, decision-making and the preparation of responses to applicants' appeal.

But where is the inspection? It is carried out everywhere, at all stages of production and advancement of the drug.

State quality control 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.

And so the goals and objectives of my course work is:

Examine for what the state quality control is carried out, from what stages it consists.

Describe and consider GMP rules

Open and describe the activities of the Federal Health Supervision Service (Roszdravnadzor).

Explore scientific articles and regulatory documentation on the quality control of drugs, deepen theoretical knowledge on this topic.

REGULATIONSGMP.

The GMP standard is the rules that establish the requirements for organizations that produce medicinal products for pharmacy and veterinary tract of medicines.

GMP rules include several chapters:

Chapter 1. Farmacetic quality system

Chapter 2. Fores

Chapter 3. Equipment and Equipment

Chapter 4. Documentation

Chapter 5. Production

Chapter 6. Quality Control

Chapter 7. Equipment transmitted to perform another organization

Chapter 8.Presentia and product review

Chapter 9.Amoinsurance

There are also basic requirements for pharmaceutical substances used as feedstock and annex to them, but this is set out below.

Consider the chapters that directly correspond to the selected topic. This is: Chapter 1, and Chapter 6.

The manufacturer must produce drugs so that they correspond to their intended, as well as quality standards, regulatory documentation regulating their quality. There should be no risks associated with incomplete safety, quality and efficiency. Responsibility for the execution of these requirements carries the manufacturer's manual.

Rules apply to all stages of the existence of medicines. Control referred to all components of production: instruments, premises, staff and so on. The quality of medication is monitored, which is taken into account when the release of each new series of drug is issued. There are various improvements in production processes and of course assessment of the changes made. Entering medicines in turnover before issuing permission by an authorized person is not allowed.

Quality control includes sampling, examinations and assessment for compliance with quality requirements. His goal is to prevent low-quality drugs in civil turnover. The manufacturer must produce regular reviews of the quality of all drugs, even those produced for export.

QUALITY CONTROL

Each manufacturer must have a quality control unit, the head of this unit must have the necessary qualifications. In assessing the quality of finished products, all factors should be taken into account, including the conditions of production, the results of control in the production process, as well as a review of the documentation. Premises and equipment for monitoring must comply with the established regulations. An open accessibility should have various documentation and protocols associated with substances, as well as ready-made drugs. Sampling and testing should be held on established standards. After the release into appeal, it is necessary to monitor the stability of medicinal raw materials.

Preliminary quality control of medicines

This is primary control of drugs based on enterprises of the Russian Federation. All drugs produced in the territory of the Russian Federation, as well as imported into the territory, are subject to this control.

Prerequisite controlmedications:

For the first time produced by the manufacturer;

First imported into the territory of the Russian Federation;

Manufactured by modified technology;

Produced after the interruption of the production of this drug from three years and more;

In connection with the deterioration of their quality.

The procedure for pre-controlling the quality of drugs includes the following steps:

Submission by the manufacturer's application with the necessary documentation in the Ministry of Health of Russia;

Analysis of documents and issuing permission of the Ministry of Health of Russia to conduct preliminary control;

Selection of drug samples;

Direction of samples for examination;

Conducting quality examination;

The decision of the Ministry of Health of Russia according to the results of the examination.

To obtain a decision on the direction to preliminary quality control of medicines, the enterprise-produces spruce directs the Ministry of Health of Russia:

Certified copy of the drug registration certificate;

Certified copies of title sheets of the State Standard of Quality and Technological Regulations of the Drug Production;

A copy of the certificate of control laboratories department of the quality control department of the manufacturer on the technical competence of produced drugs issued by the Ministry of Health of Russia.

The decision on the direction for preliminary control is issued by the Ministry of Health of Russia within 20 working days from the moment of receipt of the application and the necessary documents.

Manufacturers' enterprises for the first time producing their products must provide the first 3 industrial series of this drug.

When conducting preliminary quality control due to the deterioration of the drug, is obliged to provide 5 of the next series of drugs.

Enterprises-manufacturers performing packaging or unpacking of drugs of another manufacturer of domestic or foreign should provide 3 regular batch in packed or packaged form.

When changing the name of the medicinal product, the manufacturer must send one series of renamed drug.

The quality examination is carried out within a period of at least 30 working days from the date of the proceeding of samples. The results with the analysis protocol are sent to the Ministry of Health of Russia and the manufacturer's enterprise.

The drug will be removed from prior control and will switch to selective quality control only when all checks pass and meet quality standards. Based on the decision of the Ministry of Health of Russia on the removal of the drug with preliminary quality control, as well as the results of the examination of the effectiveness and safety of the Ministry of Health of Russia, the decision on the release of the drug in the sphere of drug treatment on the territory of the Russian Federation on the results of state quality control, efficiency, drug safety .

If there are comments to the quality of the medicinal product, it is not subject to removal of quality control. The number of a series of drug aimed at re-preliminary control determines the Ministry of Health of Russia.

Selective quality control of medicines

Selective controls are subject to drug preparations of domestic or foreign production in the sphere of circulation of drugs.

The nomenclature and frequency of sampling of drugs for selective control of the quality of drugs is governed by the selective control plan, which is approved and communicated to enterprises - drug producers in the form of task plans. During the calendar year, the task plan can be corrected taking into account the change in the nomenclature of drugs in the field of circulation in the Russian Federation, or the identified inconsistency of their quality with the requirements of state-owned quality standards of medicines.

The procedure for selective quality control of medicines includes the following steps:

The adoption of the Ministry of Health of Russia decisions on the conduct of selective quality control in accordance with the plan

Selection of drug samples

Direction for quality examination

Conducting quality examination

The decision of the Ministry of Health of Russia decisions on the results of the examination conducted.

Quality examination is carried out within a period of no more than 40 working days from the date of the preparation of the drug samples. The results of the examination of quality are sent to the Ministry of Health of Russia and the manufacturer's enterprise.

When identifying the inconsistency of quality, the Ministry of Health of Russia sends information about the seizure of the batch of poor-quality medicines into the territorial quality control bodies. After receiving information from the Ministry of Health of Russia on the detected party of the poor-quality drug, the territorial body of quality control body, on the territory of which the party of the poor-quality drug was detected, is obliged to take measures to identify and withdraw from the appeal of poor-quality medicines in the territory of the constituency of the Russian Federation.

The withdrawal and destruction of poor-quality drugs is carried out by the executive authority of the constituent entity of the Russian Federation in the manner prescribed by the current legislation of the Russian Federation.

Information on the identified number of poor-quality drugs and adopted measures for its withdrawal and destruction is sent to the Ministry of Health of Russia.

Territorial quality bodies, in the territory of which are in circulation other parties of the poor-quality drug, are obliged to take measures to verify its quality of this raw material. Information on the results of the inspection is sent to the Ministry of Health of Russia.

Selective control of the quality of certified drugs in the field of drug treatment on the territory of the Russian Federation, during their place of destination, is carried out by territorial quality control bodies within the framework of the inspection control of the quality of medicines. During the inspection verification of the quality of certified medicines in the field of appealing on the territory of the relevant constituent entities of the Russian Federation, selective quality control is carried out in terms of "Description", "Packaging", "Marking", the origin is checked, the compliance of the documentation and the State Quality Standard, belonging to this party medicines.

Samples of certified drugs for the purposes of selective control are selected by the specialists of the Ministry of Health of Russia, an authorized expert body or the territorial body control body.

If doubts occur in the accuracy of the data obtained as a result of checking the accompanying documentation and quality control of the drug in terms of "Description", "Packaging", "Marking" may be carried out additional tests. The choice of the volume of tests for the sample inspection of the quality of drugs to confirm the compliance of drugs with the requirements established by state-owned quality standards, in each particular case is determined by the territorial body quality control body. The territorial body quality control body represents information about cases of identifying the quality of medicines to the requirements of the state standards of quality, illegal copies or fakes registered in the Russian Federation of medicines, and also sends a monthly report on the results of certified drug quality inspections.

Re-selective quality control of medicines

Preparations are subject to repeated selective quality control, in the event of disputes about their quality between the subjects of drug treatment, is carried out by the decision of the Ministry of Health of Russia.

The procedure for repeated selective control includes the following steps:

Consideration by the Ministry of Health of Russia submitted documents and the decision to conduct repeated sample control

Selection of medicines for re-selective control

Direction for expertise

Examination

The adoption of the Ministry of Health of Russia decisions on the quality of drugs.

On re-control of quality, drugs can be sent by a participant in the treatment of medicines that revealed non-compliance with the requirements of quality or by the manufacturer's enterprise, which directs the archival samples of medicines to re-control.

The decision to conduct repeated selective control is made by the Ministry of Health of Russia within 20 working days, from the date of receipt of the necessary documents and applications.

The quality examination is carried out within a period of no more than 20 working days from the date of receiving the drug samples and the necessary set of documents.

The results of the examination are directed to the Ministry of Health of Russia and the subjects of the appeal to the dosage samples to repeatedly select the quality control.

Quality control of substances with pharmacological activity and intended for the production of drugs

State control of the quality of substances is carried out at the stage of their registration, as well as within the framework of preliminary quality control, as well as selective quality control of medicines on the basis of the decision of the Ministry of Health of Russia.

All substances are subject to state control at the stage of their registration, as well as substances imported into the territory of the Russian Federation and intended for the preparation of drugs.

Quality examination is carried out within a period of no more than 30 working days from the date of the receipt of samples of substances and standard samples of the substances necessary for the examination.

Order of the selection, direction and storage of drug samples for the implementation of state quality control of medicines

Samples of medicines for the preliminary, selective and re-selective quality control of drugs are selected by the specialists of the Ministry of Health of Russia or institutions that are included in the state quality control system.

Selection of samples of domestic drugs for preliminary and selective quality control is carried out with the participation of representatives of the quality control department. Selection of medicines for selective control of the quality of medicines can also be carried out when checking the manufacturer's enterprise in order to inspect the quality of medicines.

Selection of samples of foreign drugs to selective quality control is carried out from warehouses in the territory of the Russian Federation specified by the foreign manufacturer's foreign enterprise.

The Ministry of Health of Russia may transfer the authority to the selection of drug samples by territorial body quality control bodies.

Drug samples are sent to state control of the quality of medicines in the package provided for by the State Quality Standard; Samples of substances - in glass containers. Marking of drug samples must comply with the requirements of state quality standards.

To preliminary and selective control of the quality of drugs and control the quality of the substance at the registration stage, the samples are sent in an amount sufficient for three analyzes.

Samples of drugs for injection and eye drops are sent taking into account the tests of the mechanical inclusion indicator, and samples of medicinal vegetation raw materials - taking into account the results of radiation control.

Drug samples for preliminary and selective quality control are directed along with the sample substance from which they are made. Samples of substances are sent in an amount sufficient for two analyzes.

On repeated selective control of the quality of medicines, the manufacturer's enterprise sends samples of drugs in undisturbed packaging. The number of packages that make up the sample, not more than 30.

The number of drug samples sent to repeated selective control of the quality of the drug in terms of "Mechanical inclusions" and "radiation control" indicators is determined by the relevant state quality standards.

Drug samples are sent to state quality control with the accompanying letter, which indicates the type of quality control, with a certificate of quality of the medicinal product of the manufacturer and the act of sampling of medicines.

Samples of drugs sent to selective or repeated selective quality control of medicines must be accompanied by a certified copy of the certificate of the drug conformity with the analysis protocol.

Samples of substances for the examination of quality for the purpose of registration of the drug are sent to the accompanying letter, which indicates the type of quality control, and the certificate of quality of the medicine manufacturer's medicine.

Samples of drugs for injection and eye drops, sent to pre-control of quality, must be accompanied by the results of testing the quality of these drugs in terms of "Mechanical inclusions". The results of such an inspection represent the territorial controls of the quality of drug quality.

Samples of substances from which drugs submitted to preliminary and selective quality control (for domestic enterprises of manufacturers) must be accompanied by a quality certificate issued on the results of controlling the quality of the substance in its proceedings in the manufacturing enterprise for all indicators of the regulatory document, original or certified copy of the quality certificate of the manufacturer's medicine; For foreign substances, the dates of manufacture and expiration date of the substance should be additionally indicated.

Standard substance samples must be accompanied by an original or certified copy of the quality certificate of the manufacturer's medicine.

Samples of drugs remaining after conducting state quality control are stored at least 6 months, after which the samples of drugs that do not meet the requirements of the state standard of quality are to be destroyed in the prescribed manner. Drug samples that meet the requirements of state-owned quality standards are returned to manufacturing enterprises for their written request or are used in research and research purposes or donated to health care institutions.

Conclusion

The Russian Federation is where to strive because the control system is far from ideal and has a lot of flaws. But even what is now, it is already a huge plus, since quality control is required at all stages of production. Of course, there are risks, they are always and that is why the system that is now, be sure to be needed and must be improved, what in the Russian Federation and strive.

The objectives of this course work was to study the stages of state control, and deepening knowledge on this topic. Of course, I strengthened my knowledge on this topic, I hope that I was able to correctly convey all the stages, and how important they are in the manufacture of drugs.

Currently, humanity is accustomed to drugs, synthetic or vegetable. This industry carries a huge profit, as due to poor ecology, we are forced increasingly and more often to use drugs, but if they stop being qualitative, and there will be no clear tracking of the compliance of drugs to the regulation of quality, will definitely be terrible consequences. That is why it is so important to quality control of medicines.

LIST OF REFERENCES

magazine "Vestnik Roszdravnadzor" №6 (2012) Author Telnova E.A.

http://www.roszdravnadzor.ru/drugs/federalcontrol

http://brace-lf.com/

Federal Law n 61-ФЗ "On the circulation of medicines"

Book: Pletcheva T., Uspenskaya E. "Quality control of medicines. Textbook for medical schools and colleges "

Resolution of the State Committee of the Russian Federation for Standardization and Metrology of March 10, 2004 N 160-st

Scientific and practical magazine "Questory of quality of drugs"

Posted on Allbest.ru.

...

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