State control over the production of medicines is carried out. Organization of quality control of medicines

The Control and Permit System (CPC) is a set of measures to ensure the quality of drugs, medical devices, medical equipment, dietary supplements and other goods.

Tasks:

- protecting consumers from negative consequences the use of drugs;

-improvement of the quality of drugs;

- expansion of drugs and quick change of assortment;

Types of state control over the quality of medicines (project of the Ministry of Health of the Russian Federation No. 137 of 2003)

Preliminary: - medicines produced in the Russian Federation, medicines produced for the first time, medicines produced according to a modified technology are subject;

- selective: - are subject to drugs of domestic and foreign production, which are in the sphere of circulation in the Russian Federation;

- repeated selective: - in case of disputes about their quality;

- quality control of substances of various origins intended for the production of drugs;

- Periodic control of the production of drugs located on the territory of the Russian Federation.

Certification of drugs, types of certificates.

Certification is an activity to confirm the conformity of products to the norms, rules, and characteristics established in the process of standardization.

The documents:

- No. 36 of 2002 “Rules for Certification”;

Decree of the Government of the Russian Federation No. 1013 of 1997 “On approval of the list of works and services subject to mandatory certification.

2 types of drug certification:

Certificate of Conformity for Production - a document certifying, on the basis of the conclusion of a special commission, that the drug production system meets the established requirements. Issued by certification bodies: registration chamber, GNIISKLS. Expiration date - until the expiration date on the drug.

Certificate of conformity of drugs - a document that certifies the safety and compliance of the quality of drugs with the requirements of regulatory documents. Issued by certification bodies accredited by the Federal Service for Technological Regulation. Expiration date - while the product is being produced. This is where the registration certificate comes in.

Sampling for certification analysis is carried out from the manufacturer's warehouses. Sampling is carried out in accordance with the requirements of pharmacology XI ed. and in accordance with Order No. 383 of 2002.

To obtain a certificate of conformity, submit:

-registration certificate;

- a license for the right to sell drugs;

- an act of taking an average sample;

Report of the analysis of the control services of the manufacturer for domestic drugs, or a certificate of the manufacturer with an accurate translation for foreign drugs;

- protocol for the analysis of CAL.

The certificate of conformity has watermarks, w, barcode.

Product certification medical purpose, immunobiological preparations.

The documents:

1) Project No. 217 of 1998 Ministry of Health of the Russian Federation “On the hygienic assessment of the production, supply and sale of goods”

Etc. No. 274 of 1999 “On the procedure for registration of medical products. appointments and honey. technology."

For each item, a registration certificate is approved with a shelf life of 5 years, for metal and plastic inventory - 10 years.

Certificate of conformity. These documents are issued by the Federal Service for Technological Regulation and Metrology.

A hygienic certificate is also issued for hygienic products - this is a document that gives permission for the production, import and sale of products. Issued by the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotreb.nadzor).

A certificate of conformity should be obtained: dressings, disposable syringes, rubber products.

Certification of immunobiological preparations. (UPS).

In accordance with the Federal Law “On immunoprophylaxis infectious diseases” all domestic and foreign immunobiological preparations are subject to certification:

-certificate of the manufacturer for a specific series. Issued by the registration chamber and the GNII them. Tarasevich;

- certification certificate;

- certificate of conformity for a specific series of the drug. Issued by the GNII them. Tarasevich.

At the federal level, the quality control system medicines and drugs is headed by the Department state control effectiveness and safety of medicines and medical equipment of the Ministry of Health and Social Development of Russia - Scientific Center for Expertise and State Control.

At the regional level, quality control is carried out by control (testing) laboratories and drug quality control centers.

The quality standards of medicines are divided into the following categories: state quality standards for medicines (GSKLS); the pharmacopoeial article of the enterprise (FSP) for the medicinal product of a particular enterprise.

Quality standards should be reviewed in a timely manner, taking into account new achievements in the medical, pharmaceutical and other sciences, recommendations of leading international organizations in the field of pharmaceutical science and practice.

In pharmacies, quality control is carried out by a pharmacist-technologist and a pharmacist-analyst. The analysis is also carried out in control and analytical laboratories, certification and quality control institutions medicines.

The quality of medicinal products depends on the quality of the original medicinal products, therefore the state establishes special standards for their quality (quantitative content of the substance, permissible content of impurities, etc.). Impurities can get into medicinal substances during synthesis, imperfect purification methods, etc. In quantities exceeding the norm, they can have a toxic effect on the human body or affect the stability of manufactured drugs. For example, if pyrogenic substances are present in the injection solution in an amount higher than the test dose, they cause a pyrogenic reaction (fever, vomiting, etc.).

In addition to the toxic effect, impurities in medicinal substances can affect the quality of medicinal preparations, cause precipitation in solutions during sterilization, etc.

The quality standards of medicines are specified in the pharmacopoeial articles (FS) and articles of the State Pharmacopoeia. FS is a regulatory document that establishes requirements for the quality of medicines (substances) or medicinal herbal raw materials and is in the nature of a state standard.

In accordance with OST 91500. 05. 001-2000 Quality standards for medicines. The main provisions of the quality standards are: State standard for the quality of the medicinal product (GSKLS); OFS; FS; FSP, as well as documents for the imported substance: specification and the actual regulatory documents. App. 2 to OST 91500. 05. 001-2000 the rules for presenting FS and FSP for substances are given (Table 4. 1).

Table 4. 1 List of sections of FS and FSP for substances

The quality of the manufactured drug can be ensured only if the requirements in the listed areas of state regulation are unconditionally met.

In addition to the requirements for the quality of medicinal substances and excipients, regulatory documents contain directly standardized quality indicators of various dosage forms and drugs:

Quality indicators at the manufacturing stages, for example, uniformity (powders, ointments, suppositories, etc.); particle size (powders, suspension ointments); absence of mechanical inclusions (solutions for injections, ophthalmic solutions) - in accordance with the general articles of the Global Fund, orders and instructions of the Ministry of Health of Russia;

Quality indicators of the manufactured drug: for example, deviations in the mass of powders, the volume of mixtures and other dosage forms - according to the order of the Ministry of Health of Russia "On the norms of deviations permissible in the manufacture of medicines and packaging of industrial products in pharmacies" dated 16.10.1997 No. 305 ; the time of complete deformation or dissolution of suppositories - in accordance with the general article of the Global Fund; disintegration of pills - according to the general article of the GF X and other documents (FS, orders and instructions).

Intra-pharmacy control in accordance with the order of the Ministry of Health of Russia "On quality control of medicines manufactured in pharmacies" dated July 16, 1997 No. 214 includes the following types of control:

- written(which is confirmed by the PPK written control passport). The passport is issued after manufacturing (under-dosed dosage forms - potions, ointments, suspensions, emulsions, etc.) or before dividing into doses (dosed dosage forms - powders, suppositories, pills) or simultaneously with manufacturing (if one and the same specialist)

- questionnaire- an oral survey of a pharmacist or a pharmacist-technologist on the qualitative and quantitative composition of the prescription, but no later than after the manufacture of five drugs;

- physical, at the same time, the following indicators are checked: correspondence of volume, size, shape, mass (individual doses and the entire drug as a whole); melting point, disintegration time, solubility, deformation time, etc.;

- chemical consists in a qualitative and quantitative analysis of the manufactured drug;

- organoleptic, at which the smell, appearance, color, transparency, uniformity, mechanical inclusions and other organoleptic indicators are checked.

When assessing the quality of all medicinal preparations without exception, check:

Color, smell, taste (selectively in children's dosage forms) in accordance with the properties of the ingredients;

Absence of mechanical inclusions: cotton wool hairs, cork crumbs, etc.;

Deviation in the mass or volume of the medicinal product;

Compliance of packaging and capping with the mass (volume) and type of dosage form, as well as the properties of the incoming ingredients;

Check for appropriate primary labels, as well as warning labels or supplementary labels;

The accompanying documents are analyzed: the presence of a correctly written and executed prescription (if necessary, a signature), a written control passport, which testify to the correctness of checking the compatibility of ingredients, doses of toxic and potent substances, compliance with the norm for the release of narcotic medicinal substances and the calculation of prescription components prescription.

In addition, the assessment of the quality of the medicinal product is carried out depending on the specifics of the dosage form.

Quality control of intra-pharmaceutical preparations. In the presence of a pharmacist-analyst or a pharmacist-technologist (“under supervision”), fragrant waters and medicinal preparations for external use are made containing the following substances: de-got, ichthyol, sulfur, Naftalan oil, collodion, lead water and others substances, the chemical analysis of which cannot be performed in a pharmacy. Also, under supervision, medicines for newborns are manufactured that do not have methods for qualitative and quantitative analysis.

The quality of homeopathic preparations is also assessed in accordance with the requirements of the Global Fund, orders and instructions of the Ministry of Health and social development Russia.

All medicinal products must comply with the standards of microbiological purity.

A unique quality control system for homeopathic preparations was proposed by F. R. Chernikov, based on the method of molecular fluctuation light scattering (on the AGLS-EDAS device) with the support of the EDAS company. This control system can be used along with a complex of traditional physical and chemical methods for assessing quality.

The following are subjected to verification: raw materials, all technological stages, all parts and components of technological equipment, finished preparations for their influence on the state of the medicinal environment and the possibility of introducing an extraneous distorting influence into finished preparations. The use of this method makes it possible to identify a wide range of factors that “disturb” medicinal media, eliminate them from production, and optimize the technological process.

The method is based on comparison of a controlled sample with a reference one. In the AGLS-EDAS device, the spectrum is taken in the selected sample and compared with the standard spectrum using the appropriate programs. The degree of similarity is estimated by the degree of overlapping of the spectra and is characterized by the coefficient of the degree of similarity (the proportion of the spectrum of the control sample that went beyond the permissible limits).

In accordance with the Order of the Ministry of Health of Russia "On the quality control of medicines manufactured in pharmacies" dated July 16, 1997 No. 214, two terms are used to assess the quality of manufactured products: "satisfies" (good products) and "does not satisfy" (marriage ) the requirements of the Global Fund, orders and instructions of the Ministry of Health of Russia.

In accordance with the Federal Law of the Russian Federation "On Certification of Products and Services" dated June 10, 1993 No. 5151-1 (as amended on July 31, 1998, as amended on November 22, 2001), regional control centers quality certification of medicines is currently carried out in order to:

Creation of conditions for the activities of enterprises, institutions, organizations, entrepreneurs in the single commodity market of Russia and in international markets;

Protection of consumers from dishonesty of the manufacturer;

Product safety control for environment, life, health;

Confirmation of product quality indicators declared by the manufacturer.

test questions

1. What is the state regulation of the production and quality control of medicines?

2. In what areas is state regulation carried out in Russia?

3. How is the composition of the medicinal product regulated? What are standard and non-standard prescriptions?

4. What is a prescription? What is its structure?

5. What is the State Pharmacopoeia, general and private pharmacopoeial articles?

6. How are the conditions for the manufacture (production) of drugs regulated?

7. What are the norms for non-pathogenic microorganisms in non-sterile medicinal preparations? Which microorganisms should be absent and why?

8. Compare the regulation of the manufacturing technology of allopathic and homeopathic medicines.

The instruction establishes that the state quality control of chemical-pharmaceutical, hormonal, vitamin, enzyme preparations, antibiotics, drugs obtained from animal and vegetable raw materials, radiopharmaceuticals, diagnostic kits is carried out by the Department of the Ministry of Health of the Russian Federation through control and analytical laboratories (CCCL), NIIKLS and others Research Institute. All drugs produced both by domestic enterprises, regardless of ownership and subordination, and imported through pharmacy bases (warehouses) are subject to state control.

State control of drugs is carried out in the form of:

- preliminary, those. control of the first 5 batches of the medicinal product, produced for the first time by this enterprise or
transferred for any reason to this type of control by the Department of the Ministry of Health of the Russian Federation;

- selective(subsequent), i.e. control of any series of medicinal products withdrawn from the warehouse of the manufacturer,
from a place of storage or from a pharmacy;

- arbitration control, conducted in case of disputes about the quality of medicines between the supplier and
consumer.

Analysis of samples received for state control must be carried out within no more than 30 days. In the event of a defect, the Department issues an order to seize the defective drugs.

State control is also carried out in the process certification drugs and during inspection. Inspection checks consist in planned quality control of drugs at enterprises and organizations that produce, store and sell drugs, regardless of their organizational and legal status.

The "Instructions on the procedure for conducting state quality control of drugs used in the territory of the Russian Federation" provide common features and differences in the procedure for conducting state control of domestic and foreign drugs in all three of its types: preliminary, subsequent selective and arbitration.

From domestic drugs preliminary sampling control subject to: first time permitted to medical use or first mass-produced at this enterprise; mass-produced at this enterprise according to a modified technology or upon obtaining a license for production; transferred to this type of control by the Department of the Ministry of Health of the Russian Federation in connection with the transition to the use of imported substances. Transfer (reverse) from preliminary to subsequent sampling control is allowed by the Department if its quality meets all the requirements of RD for at least five series in a row.

Subsequent sampling all mass-produced drugs are subjected (according to the plans-tasks of the Department). LP samples with a cover letter and an act of taking an average sample are sent to NIIKLS. At positive results analysis, NIIKLS notifies the manufacturer from which the samples were taken. If a discrepancy between the quality of the samples and the requirements of RD is revealed, NIIKLS sends a written conclusion with the analysis protocol to the same address.

Arbitration control conducted by NIIKLS. Medicinal product samples for arbitration analyzes are sent to the research institutes with a cover letter, an act of taking an average sample, an analysis protocol for all ND indicators and a written conclusion of the manufacturer about the refusal to satisfy the consumer's claims.

Foreign medicinal products also go through all the indicated stages of state control.

The first three series of drugs purchased for the first time are subject to preliminary control. Samples for its implementation are sent by the pharmacy base (warehouse) within ten days from the moment they are received.

Antibiotics, hormonal, enzymatic and other medicinal products from animal raw materials are subjected to subsequent control for all ND indicators; chemical and pharmaceutical preparations that require testing for sterility and pyrogenicity (selectively for these indicators, as directed by the Department of the Ministry of Health of the Russian Federation). The remaining purchased drugs are subject to subsequent control selectively according to the NIIKLS plan.

All batches of foreign drugs are subject to arbitration control, the quality assessment of which revealed deviations from the requirements of the regulatory documents. Samples for analysis are sent to NIIKLS by the organization that has identified the non-compliance of the medicinal product with the requirements of the ND, a claim is made to the manufacturer.

5.6.3. Selection of an average sample for state control

When sampling (sampling) medicines, they are guided by the requirements of the Global Fund XI (issue 2, p. 15) and the requirements of the Federal Assembly (FSP).

Samples (samples) are taken from individual series (batches) of drugs after an external examination, only from packaging units that are undamaged, sealed and packed in accordance with the requirements of ND. When sampling poisonous and narcotic drugs, it is necessary to follow the rules provided for by the relevant orders, regulations, instructions approved by the Ministry of Health of the Russian Federation.

To test drugs for compliance with the requirements of ND, multi-stage sampling (sampling) is carried out. In this case, the sample is formed in stages and drugs in each stage are randomly selected in proportional quantities from the units selected in the previous stage. The number of steps is determined by the type of packaging:

1st stage: selection of packaging units (boxes, bags, boxes, etc.);

2nd stage: selection of packaging units in packaging (boxes, bottles, cans, etc.);

3rd stage: selection of products in primary packaging (ampoules, vials, tubes, etc.).

Of the packaging units selected at the last stage after control by appearance take a sample to control the quality of drugs for compliance with the requirements of ND. The number of drugs should be sufficient to conduct 4 complete analyzes for all sections of the FS (FSP). The sampling procedure for drug control for sterility, pyrogenicity, toxicity and other special types of control is specified in the OFS (GF X1, v.2) or FS (FSP).

The selection of the average sample is completed by drawing up the “Act of the selection of the average sample”, which indicates the name of the drug, the batch number, the total number of drugs, the number of drugs taken. The act is drawn up and signed by a commission, which includes the head of the Quality Control Department, a representative of the KanL (or the customer).

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Ministry of Health care Russian Federation

GBOU VPO St. Petersburg Chemical Pharmaceutical Academy

Pharmaceutical College

Specialty 330201 "Pharmacy"

PM 01. Sale of medicines and pharmacy products.

MDK 01.02. Dispensing of medicines and pharmacy products

COURSE WORK

"SYSTEM OF STATE QUALITY CONTROL OF MEDICINES"

3rd year students of group No. 261

Mamontova Elizabeth Stanislavovna

Head of work Oreshkova Tatyana Aleksandrovna

Introduction

GMP rules

Preliminary quality control of medicines

Selective quality control of medicines

Repeated selective quality control of medicines

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

The procedure for selecting, sending and storing samples of medicinal products for state control of the quality of medicinal products

Conclusion

Bibliography

INTRODUCTION

drug quality control

I became interested in this topic because I think that the buyer, which I am too, has the right to receive only proven and high-quality products, and especially medicines. It is interesting for me to reveal the stages of state control in more detail and to be competent in this area.

What is quality? Quality is the characteristics of an object that satisfy the needs of consumers in our case. But if in the field of the food industry or clothing infrastructures the buyer can assess the quality himself, in the drug industry he cannot do this, so the help of authorized bodies is required. To assess the technical level of production and quality of medicines, the World Health Organization created the “Certification System for the Quality of Pharmaceuticals in International Trade”, the current version of which was adopted in 1992.

To participate in the System, three conditions must be met in the country:

State registration of medicines;

Regular state inspection of pharmaceutical enterprises;

Compliance of existing production facilities with the requirements of GMP rules

In the Russian Federation, state control is carried out by the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Decree of the Government of the Russian Federation of June 30, 2004 No. 323 “On Approval of the Regulations on the Federal Service for Surveillance in the Sphere of Health Care” (clause 5.1.4.2.) vested in Roszdravnadzor the powers of federal state supervision in the field of circulation of medicines by conducting compliance checks of medicines mandatory quality requirements.

All medicines produced in the Russian Federation, as well as imported from other countries, are subject to verification. Control over the completeness and quality of the implementation of state supervision includes conducting inspections, identifying and eliminating violations of the rights of applicants, taking measures to suppress identified violations of mandatory requirements and eliminate the consequences of such violations, consideration, decision-making and preparation of responses to applicants' appeals.

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

State quality control is carried out in the form of:

Preliminary quality control of medicines;

Selective quality control of medicines;

Repeated selective quality control of medicines;

Quality control of substances of plant, animal or synthetic origin with pharmacological activity and intended for the production of medicines;

Carrying out periodic inspections of enterprises - manufacturers of medicines located in the territories of the constituent entities of the Russian Federation, in order to inspect the quality of the medicines they produce.

And so the goals and objectives of my term paper this is:

To study why state quality control is carried out, what stages it consists of.

Describe and review GMP rules

Disclose and describe the activities of the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Research science articles and regulatory documentation on the issue of quality control of medicines, to deepen theoretical knowledge on this topic.

REGULATIONSGMP

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

GMP rules include several chapters:

Chapter 1. Pharmaceutical Quality System

Chapter 2. Staff

Chapter 3. Premises and equipment

Chapter 4 Documentation

Chapter 5

Chapter 6 Quality Control

Chapter 7

Chapter 8. Claims and Product Recall

Chapter 9 Self-Inspection

There are also basic requirements for pharmaceutical substances used as raw materials and supplements to them, but these are outlined below.

Consider those chapters that directly correspond to the chosen topic: chapter 1, and chapter 6.

The manufacturer is obliged to produce medicinal products in such a way that they meet their intended purpose, as well as quality standards, regulatory documents regulating their quality. There should be no risks associated with incomplete safety, quality and efficacy. The manufacturer's management is responsible for meeting these requirements.

The rules apply to all stages of the existence of medicines. Controls are carried out relating to all components of production: devices, premises, personnel, and so on. Quality is monitored medications, which is taken into account with the release of each new series of the drug. There are various improvements in production processes and, of course, an assessment of the changes made. The introduction of medicinal products into circulation before the issuance of a permit by an authorized person is not allowed.

Quality control includes sampling, examination and assessment for compliance with quality requirements. Its goal is to prevent low-quality drugs from entering the civil circulation. The manufacturer is obliged to conduct regular quality reviews of all medicinal products, 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. When assessing the quality of the finished product, all factors should be taken into account, including production conditions, the results of control in the production process, as well as a review of documentation. Premises and equipment for monitoring must comply with the established regulations. Various documentation and protocols related to substances, as well as finished medicinal products, should be openly available. Sampling and testing must be carried out in accordance with established standards. After release into circulation, it is necessary to monitor the stability of medicinal raw materials.

PRELIMINARY QUALITY CONTROL OF DRUGS

This is the primary control of medicines, based on manufacturing enterprises of the Russian Federation. This control is subject to all medicinal products produced in the territory of the Russian Federation, as well as imported into the territory.

Subject to preliminary controlmedications:

For the first time produced by the manufacturer;

For the first time imported into the territory of the Russian Federation;

Produced by modified technology;

Produced after a break in the production of this medicinal product for three years or more;

Due to the deterioration of their quality.

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

Submission by the manufacturer of an application with the necessary documentation to the Ministry of Health of Russia;

Analysis of documents and issuance of permission by the Ministry of Health of Russia for preliminary control;

Sampling of medicines;

Sending samples for examination;

Conducting a quality assessment;

Decision-making by the Ministry of Health of Russia based on the results of the examination.

In order to obtain a decision on sending for preliminary quality control of medicinal products, the manufacturing enterprise spruce sends the Ministry of Health of Russia:

certified copy registration certificate for a medicinal product;

Certified copies of the title pages of the state quality standard and technological regulations for the production of the medicinal product;

A copy of the certificate of control laboratories of the quality control department of the manufacturing enterprise for the technical competence of the manufactured medicinal products, issued by the Ministry of Health of Russia.

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

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

When conducting preliminary quality control due to the deterioration of the medicinal product, they are required to provide 5 regular batches of the medicinal product.

Manufacturers engaged in packaging or unpacking medicines from another manufacturer, domestic or foreign, must provide 3 consecutive batches in packaged or packaged form.

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

Examination of quality is carried out within a period of at least 30 working days from the date of receipt of the samples. The results with the protocol of analysis are sent to the Ministry of Health of Russia and the manufacturing company.

The medicinal product will be removed from the preliminary control and transferred to random quality control only when it passes all the checks and meets the quality standards. Based on the decision of the Ministry of Health of Russia to remove the medicinal product from preliminary quality control, as well as on the basis of the results of the examination of effectiveness and safety, the Ministry of Health of Russia draws up a decision to release the medicinal product into the sphere of circulation of medicines in the Russian Federation based on the results of state control of the quality, efficacy, safety of medicines .

If there are comments on the quality of the medicinal product, it is not subject to removal from the preliminary quality control. The number of batches of a medicinal product sent for repeated preliminary control is determined by the Ministry of Health of Russia.

SELECTIVE QUALITY CONTROL OF MEDICINES

Selective control is subject to medicinal products of domestic or foreign production that are in the field of circulation of medicinal products.

The nomenclature and frequency of taking samples of drugs for random quality control of medicines is regulated by a sampling plan, which is approved and brought to the attention of drug manufacturers in the form of task plans. During the calendar year, the task plan may be adjusted taking into account changes in the range of medicines that are in circulation in the Russian Federation, or the identified non-compliance of their quality with the requirements of state quality standards for medicines.

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

Adoption by the Russian Ministry of Health of the decision to conduct random quality control in accordance with the plan

Sampling of medicinal products

Referral for quality assessment

Conducting a quality assessment

Adoption by the Ministry of Health of Russia of a decision based on the results of the examination.

The quality examination is carried out within a period of not more than 40 working days from the date of receipt of the medicinal product samples. The results of the quality examination are sent to the Ministry of Health of Russia and the manufacturing company.

If a quality discrepancy is identified, the Ministry of Health of Russia sends information about the seizure of a batch of low-quality medicines to the territorial quality control authorities. After receiving information from the Ministry of Health of Russia about a detected batch of a low-quality medicinal product, the territorial quality control authority on whose territory the batch of low-quality medicinal product was found is obliged to take measures to identify and withdraw from circulation low-quality medicines on the territory of the constituent entity of the Russian Federation.

The seizure and destruction of low-quality medicinal products is carried out by the executive authority of the subject of the Russian Federation in the manner prescribed by the current legislation of the Russian Federation.

Information about the detected quantity of a low-quality medicinal product and the measures taken for its withdrawal and destruction is sent to the Ministry of Health of Russia.

Territorial quality authorities, on whose territory other batches of a low-quality medicinal product are in circulation, are obliged to take measures to check its quality of this raw material. Information about the results of the check is sent to the Ministry of Health of Russia.

Selective quality control of certified medicinal products that are in the sphere of circulation of medicinal products on the territory of the Russian Federation, when they arrive at their destination, is carried out by the territorial quality control authorities as part of the inspection control of the quality of medicinal products. In the course of an inspection check of the quality of certified medicines in the sphere of circulation on the territory of the relevant constituent entities of the Russian Federation, selective quality control is carried out in terms of "description", "packaging", "labeling", the origin, compliance of the medicinal product with documentation and the state quality standard, belonging to this batch are checked medicines.

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

If there are doubts about the reliability of the data obtained as a result of checking the accompanying documentation and quality control of the medicinal product in terms of "description", "packaging", "labeling", additional tests may be carried out. The choice of the scope of tests to be carried out for selective verification of quality indicators of medicines, which make it possible to confirm the compliance of medicines with the requirements established by state quality standards, is determined in each specific case by the territorial body for quality control of medicines. The territorial authority for quality control of medicines submits to the Ministry of Health of Russia information on cases of detection of non-compliance of the quality of medicines with the requirements of state quality standards, illegal copies or counterfeits of medicines registered in the Russian Federation, and also sends a monthly report on the results of quality checks of certified medicines.

REPEATED SAMPLE QUALITY CONTROL OF MEDICINES

Drugs are subject to repeated selective quality control in case of disputes about their quality between the subjects of circulation of medicines, carried out by decision of the Ministry of Health of Russia.

The re-sampling procedure includes the following steps:

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

Sampling of medicines for re-sampling

Referral for examination

Conducting an examination

Adoption by the Ministry of Health of Russia of a decision on the quality of medicines.

Medicinal products can be sent for re-quality control by a participant in the circulation of medicinal products that has identified non-compliance with quality requirements or by a manufacturing enterprise that sends archival samples of medicinal products for re-control.

The decision to conduct a 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 application.

Quality examination is carried out within a period of not more than 20 working days from the date of receipt of samples of the medicinal product and the necessary set of documents.

The results of the examination are sent to the Ministry of Health of Russia and the subjects of circulation that provided samples of the medicinal product for repeated selective quality control.

QUALITY CONTROL OF SUBSTANCES WITH PHARMACOLOGICAL ACTIVITY AND INTENDED FOR THE PRODUCTION OF MEDICINES

State quality control 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 based on the decision of the Russian Ministry of Health.

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 medicines.

The examination of quality is carried out within a period of not more than 30 working days from the date of receipt of samples of substances and standard samples of substances necessary for the examination.

PROCEDURE FOR SELECTION, SENDING AND STORAGE OF SAMPLES OF MEDICINAL PRODUCTS FOR IMPLEMENTATION OF STATE QUALITY CONTROL OF MEDICINAL PRODUCTS

Samples of medicines for preliminary, selective and repeated selective quality control of medicinal products are selected by specialists of the Ministry of Health of Russia or institutions that are part of the state quality control system.

The selection of samples of domestic medicinal products for preliminary and selective quality control is carried out with the participation of representatives of the quality control department. Sampling of medicines for selective quality control of medicines can also be carried out during inspections of the manufacturing enterprise for the purpose of inspecting the quality of medicines.

Sampling of foreign medicinal products for selective quality control is carried out from warehouses in the territory of the Russian Federation indicated by the foreign manufacturer.

The Ministry of Health of Russia may delegate the authority to take samples of medicines to territorial bodies for quality control of medicines.

Samples of medicines are sent for state quality control of medicines in the packaging provided for by the state quality standard; samples of substances - in glass containers. Labeling of samples of medicines must comply with the requirements of state quality standards.

For preliminary and selective quality control of medicines and quality control of the substance at the stage of registration, samples are sent in a quantity sufficient for three analyzes.

Samples of medicines for injection and eye drops sent taking into account the tests of the indicator "mechanical inclusions", and samples of medicinal plant materials - taking into account the results of radiation monitoring.

Samples of medicines for preliminary and selective quality control are sent along with a sample of the substance from which they are made. Substance samples are sent in sufficient quantity for two analyses.

For repeated random quality control of medicines, the manufacturer sends samples of medicines in intact packaging. The number of packages that make up the sample is not more than 30.

The number of samples of medicinal products sent for re-selective quality control of the medicinal product in terms of "Mechanical inclusions" and "Radiation control" is determined by the relevant state quality standards.

Samples of medicinal products are sent for state quality control with a cover letter indicating the type of quality control, with a certificate of quality of the medicinal product of the manufacturer and an act of sampling of medicinal products.

Samples of medicinal products sent for selective or re-selective quality control of medicinal products must be accompanied by a certified copy of the certificate of conformity of the medicinal product with the analysis protocol.

Samples of substances for quality examination for the purpose of registration of a medicinal product are sent with a cover letter indicating the type of quality control, and a certificate of quality of the medicinal product from the manufacturer.

Samples of medicines for injections and eye drops sent for preliminary quality control must be accompanied by the results of checking the quality of these medicines in terms of "Mechanical inclusions". The results of such a check are presented by the territorial authorities for quality control of medicines.

Samples of substances from which medicinal products are produced, submitted for preliminary and selective quality control (for domestic manufacturers), must be accompanied by a quality certificate issued based on the results of the quality control of the substance when it enters production at the manufacturing enterprise for all indicators normative document, the original or a certified copy of the quality certificate of the medicinal product of the manufacturer; for foreign substances, the dates of manufacture and expiration date of the substance must be additionally indicated.

Standard samples of the substance must be accompanied by the original or a certified copy of the quality certificate of the medicinal product of the manufacturer.

Samples of medicinal products remaining after state quality control are stored for at least 6 months, after which samples of medicinal products that do not meet the requirements of the state quality standard are subject to destruction in the prescribed manner. Samples of medicines that meet the requirements of state quality standards are returned to manufacturing enterprises at their written request or used for research purposes or donated to healthcare institutions.

CONCLUSION

The Russian Federation has much to strive for because the control system is far from ideal and has many shortcomings. But even what we have now is already a huge plus, since quality control is mandatory at all stages of production. Of course, there are risks, they always exist, and that is why the system that exists now is absolutely necessary and must be improved, which is what the Russian Federation is striving for.

The objectives of this course work was to study the stages of state control, and deepen 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 production of medicines.

At present, humanity is accustomed to drugs, synthetic or herbal. This industry brings huge profits, because due to poor ecology, we are forced to use medicines more and more often, but if they cease to be of high quality, and there is no clear monitoring of the compliance of medicines with quality regulations, there will certainly be terrible consequences. That is why quality control of medicines is so important to us.

BIBLIOGRAPHY

journal "Bulletin of Roszdravnadzor" No. 6 (2012) Author Telnova E.A.

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

http://brace-lf.com/

Federal Law N 61-FZ "On the Circulation of Medicines"

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

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

Scientific and practical journal "Issues of quality assurance of medicines"

Hosted on Allbest.ru

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MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

On approval of the implementation procedure
state control of the quality of medicinal
funds

Revoked due to
Order of the Ministry of Health and Social Development of Russia dated October 30, 2006 N 734
____________________________________________________________________

____________________________________________________________________

For explanations of this order, see the letter of the Department of State Control of Medicines and Medical Equipment dated 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" (Collected Legislation of the Russian Federation, 1998, N 26, Art. 3006; 2000, N 2, Art. 126; 2002 , N 1 (part I), article 2; 2003, N 2, article 167)

I order:

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

2. Recognize invalid the order of the Ministry of Health and Medical Industry of Russia dated March 25, 1994 N 53 (registered by the Ministry of Justice of Russia on May 20, 1994, registration N 571).

Minister
Y. Shevchenko

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

Application. The procedure for exercising state control over 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 defines the procedure for conducting state quality control of medicines on the territory of the Russian Federation (with the exception of radiopharmaceutical, immunobiological medicines, blood products and blood substitutes) and is mandatory for all subjects of medicines circulation.

State quality control of medicines is carried out in the form of:

- preliminary quality control of medicines;

- selective quality control of medicines;

- repeated selective quality control of medicines;

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

- conducting periodic inspections of enterprises - manufacturers of medicines located in the territories of the constituent entities of the Russian Federation, in order to inspect the quality of the medicines they produce.

II. Preliminary quality control of medicines

2.1. Preliminary quality control is subject to medicinal products manufactured by enterprises - manufacturers of medicinal products (hereinafter referred to as the manufacturing enterprise) in the territory of the Russian Federation;

- for the first time produced by the manufacturer;

- for the first time imported into the territory of the Russian Federation;

- produced by modified technology;

- produced after a break in the production of this medicinal product for three years or more;

- due to the deterioration of their quality.

2.2. The procedure for preliminary quality control of medicines includes the following steps:

- sending by the manufacturer to the Ministry of Health of Russia an application with a set of necessary documents;

- analysis of documents and issuance by the Ministry of Health of Russia of a permit for preliminary quality control of medicines;

- sampling of medicines for the purposes of preliminary quality control of medicines;

- sending samples of medicines for examination of the quality of medicines (Chapter VI of this Procedure);



- adoption by the Ministry of Health of Russia of a decision based on the results of the examination of the quality of medicines.

2.3. To obtain a decision on sending for preliminary quality control of medicines, the manufacturer sends to the Ministry of Health of Russia:

- application;

- duly certified copy of the registration certificate for the medicinal product;

- duly certified copies of the title pages of the state quality standard and the technological regulations for the production of the medicinal product agreed in the prescribed manner;

- a copy of the certificate of control laboratories of the quality control department (hereinafter referred to as QCD) of the manufacturing enterprise for technical competence in the field of quality control of manufactured medicines, issued in the prescribed manner by the Ministry of Health of Russia.

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

2.5. Manufacturers that start serial production of a medicinal product for the first time must send samples of the first three industrial batches of this medicinal product for preliminary quality control of medicinal products as they become available.

When carrying out by the decision of the Ministry of Health of Russia preliminary quality control of the medicinal product due to the deterioration of its quality, five regular batches of the medicinal product are subject to control.

2.6. Manufacturers engaged in packaging or packaging of medicinal products manufactured by other manufacturing enterprises (domestic or foreign) must send samples of three industrial batches of a packaged or prepackaged medicinal product for preliminary quality control of medicinal products.

2.7. When changing the name of a medicinal product, the manufacturer sends one batch of the renamed medicinal product for preliminary quality control of medicinal products.

2.8. The examination of the quality of the medicinal product is carried out within a period not exceeding 30 working days from the date of receipt of samples of the medicinal product and a set of documents, unless the state quality standard provides for quality control methods that require longer periods for the examination of the quality of this medicinal product.

2.9. Upon completion of the examination of the quality of the medicinal product, the results with the protocol of analysis are sent to the Ministry of Health of Russia and the manufacturer.

2.10. The medicinal product is removed from the preliminary quality control of medicinal products and transferred to selective quality control of medicinal products by decision of the Ministry of Health of Russia, if the quality of all submitted samples of the medicinal product meets the requirements of the state quality standard for this medicinal product.

Based on the decision of the Ministry of Health of Russia to withdraw the medicinal product from the preliminary quality control of medicinal products, as well as on the basis of the results of the examination of the effectiveness and safety of the medicinal product, the Ministry of Health of Russia issues a decision to release the medicinal product into the sphere of circulation of medicinal products in the Russian Federation based on the results of state control quality, efficacy, safety of medicines. This decision is the basis for issuing to the manufacturer the conclusion of the Ministry of Health of the Russian Federation on the compliance of the organization of the production of the medicinal product by the manufacturer with the requirements of the Federal Law "On Medicines".

2.11. If there are comments on the quality of the medicinal product based on the results of the examination of the quality of this medicinal product, it is not subject to removal from the preliminary control. The number of batches of a medicinal product sent by the manufacturer for repeated preliminary control is determined by the Ministry of Health of Russia based on the results of the examination of the quality of the medicinal product.

III. Selective quality control of medicines

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

The nomenclature and frequency of taking samples of medicines for random quality control of medicines are regulated by a sampling plan, which is approved in the prescribed manner and brought to the attention of enterprises - manufacturers of medicines in the form of task plans.

During the calendar year, the plan-task may be adjusted taking into account changes in the range of medicines that are in circulation in the Russian Federation, or revealed inconsistencies in their quality with the requirements of state quality standards for medicines.

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

- adoption by the Ministry of Health of Russia of a decision to conduct selective quality control of medicinal products in accordance with the approved plan for selective quality control of medicinal products;

- sampling of medicines for the purpose of selective quality control of medicines;



- conducting an examination of the quality of the submitted samples of medicines;

- adoption by the Ministry of Health of Russia of a decision based on the results of the examination of the quality of the medicinal product.

3.3. Examination of the quality of the medicinal product is carried out within a period not exceeding 40 working days from the date of receipt of the samples of the medicinal product and a set of documents, if the state standard for the quality of the medicinal product does not provide for quality control methods that require longer periods for their implementation.

3.4. The results of the examination of the quality of the medicinal product as part of the selective quality control of medicinal products are sent to the Ministry of Health of Russia and the manufacturer.

3.5. If the quality of the medicinal product of the manufacturing enterprise is revealed to be inconsistent with the requirements of the state quality standard, the Ministry of Health of Russia sends information about the withdrawal of a batch of low-quality medicinal product to the territorial authorities for quality control of medicinal products.

After receiving information from the Ministry of Health of Russia about a detected batch of a low-quality medicinal product, the territorial quality control authority on whose territory the batch of low-quality medicinal product was found is obliged to take measures to identify and withdraw from circulation the low-quality medicinal product in the jurisdictional territory of the constituent entity of the Russian Federation. Withdrawal and destruction of low-quality medicines 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 about the detected quantity of a low-quality medicinal product and the measures taken for its withdrawal and destruction is sent to the Ministry of Health of Russia.

3.6. Territorial quality control authorities, on the territory of which other batches of a low-quality batch of a medicinal product are in circulation, are obliged to take measures to check the quality of this medicinal product. Information about the results of such a check is sent to the Ministry of Health of Russia.

3.7. Selective quality control of certified medicinal products that are in the sphere of circulation of medicinal products on the territory of the Russian Federation, when they arrive at their destination, is carried out by the territorial quality control authorities as part of the inspection control of the quality of medicinal products.

3.8. In the course of an inspection check of the quality of certified medicinal products in circulation on the territory of the relevant constituent entities of the Russian Federation, selective quality control is carried out in terms of "description", "packaging", "labeling", the origin, compliance of the medicinal product with the accompanying documentation and the state quality standard, belonging to this batch of medicines.

3.9. Samples of certified medicinal products for the purposes of selective control are selected by specialists of the Ministry of Health of Russia, an expert body authorized by the Ministry of Health of Russia or a territorial quality control body.

3.10. If there are doubts about the reliability of the data obtained as a result of checking the accompanying documentation and quality control of the medicinal product in terms of "description", "packaging", "labeling", additional tests may be carried out. The choice of the scope of tests to be carried out for selective verification of quality indicators of medicines, which allow to fully and reliably confirm the compliance of medicines with the requirements established by state quality standards, in each case is determined by the territorial body for quality control of medicines.

3.11. The territorial authority for quality control of medicines submits to the Ministry of Health of Russia information on cases of detection of non-compliance of the quality of medicines with the requirements of state quality standards, illegal copies or counterfeits of medicines registered in the Russian Federation, and also sends a monthly report on the results of quality checks of certified medicines.

IV. Repeated selective quality control of medicines

4.1. Medicinal products are subject to repeated selective quality control of medicinal products in case of disputes about their quality between the subjects of medicines circulation.

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

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

- sending by the manufacturing enterprise to the Ministry of Health of Russia an application for repeated selective quality control of the medicinal product and the necessary documents with justification for the need for it;

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

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

- sending samples of medicines for examination of the quality of medicines in accordance with Chapter VI of this Procedure;

- conducting an examination of the quality of the submitted samples of medicines;

- adoption by the Ministry of Health of Russia of a decision on the presented results of the examination of the quality of the medicinal product.

4.4. Medicinal products may be sent for re-selective quality control of medicinal products by the participant in the circulation of medicinal products, which has identified non-compliance of medicinal products with the requirements of state quality standards, and by the manufacturer, which sends archival samples of this medicinal product for re-selective control.

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

4.6. Examination of the quality of a medicinal product for the purposes of re-selective quality control of medicinal products is carried out within a period of not more than 20 working days from the date of receipt of samples of the medicinal product and a set of documents, if the state quality standard does not provide for control methods that require longer periods for their implementation.

4.7. The results of the examination of the quality of the medicinal product with the protocol of analysis are sent to the Ministry of Health of Russia and the subjects of medicines circulation that submitted samples of the medicinal product for repeated random control of the quality of medicinal products.

V. Quality control of substances of plant, animal, microbial or synthetic origin with pharmacological activity and intended for the production of medicines

5.1. State quality control of substances of plant, animal, microbial or synthetic origin with pharmacological activity and intended for the production of medicines (hereinafter referred to as 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 on the basis of a decision Ministry of Health of Russia in accordance with chapters II and III of this Procedure.

5.2. All substances are subject to quality examination at the stage of their registration, 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 not more than 30 working days from the date of receipt of samples of the substance and standard samples of substances necessary for the examination of quality, if the state quality standard does not provide for control methods that require longer periods for their implementation.

VI. The procedure for selecting, sending and storing samples of medicines for the implementation of state control of the quality of medicines

6.1. Sampling procedure for medicines

6.1.1. Samples of medicines for preliminary, selective and re-selective quality control of medicines are selected by specialists of the Ministry of Health of Russia and (or) institutions included in the state system for monitoring the quality, efficacy, safety of medicines, based on the decision of the Ministry of Health of Russia.

The selection of samples of domestic medicines for preliminary and selective quality control of medicines is carried out with the participation of representatives of the quality control department for repeated random quality control of medicines - from archive samples of medicines of the QCD of the manufacturer. Sampling of medicinal products for selective quality control of medicinal products may also be carried out during inspections of the manufacturing enterprise in order to inspect the quality of medicinal products.

Sampling of foreign medicines for selective quality control of medicines is carried out from warehouses in the territory of the Russian Federation indicated by the foreign manufacturer.

6.1.2. The Ministry of Health of Russia may delegate the authority to take samples of medicines to territorial authorities for quality control of medicines.

6.1.3. The Subject of Medicines Circulation in the territory of the Russian Federation, which has identified the non-compliance of medicines with the requirements of the state quality standard, shall submit samples of the non-conforming medicine for re-selective quality control of medicines in an amount sufficient to conduct an analysis according to the quality indicator under study and the “authenticity” indicator.

6.2. The procedure for sending samples of medicines for state quality control of medicines

6.2.1. Samples of medicines are sent for state quality control of medicines in the packaging provided for by the state quality standard; samples of substances - in glass containers. Labeling of samples of medicines must comply with the requirements of state quality standards.

6.2.2. For preliminary and selective quality control of medicines and quality control of the substance at the stage of registration, samples of medicines are sent in an amount sufficient for three analyzes in accordance with the requirements of the state standard for the quality of the medicine (taking into account the test for microbiological purity).

Samples of medicines for injections and eye drops are sent taking into account the tests of the "mechanical inclusions" indicator, and samples of medicinal plant materials - taking into account the results of radiation monitoring.

6.2.3. Samples of medicinal products sent for preliminary or selective quality control of medicinal products, as well as samples of substances must be accompanied by standard samples of substances and substances necessary for control in accordance with state quality standards.

6.2.4. Samples of medicines for preliminary quality control of medicines are sent together with a sample of the substance from which they are made. Substance samples are sent in a quantity sufficient for two analyzes in accordance with the approved state quality standard.

For selective quality control of medicines, samples of domestic medicines are sent with an archival sample of the substance in an amount sufficient to conduct two analyzes in accordance with the approved state quality standard.

6.2.5. For repeated random quality control of medicines, the manufacturer sends samples of medicines in intact packaging. The number of packages that make up 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 samples of medicinal products sent for re-selective quality control of the medicinal product in terms of "Mechanical inclusions" and "Radiation control" is determined by the relevant state quality standards.

6.3. Accompanying documents

6.3.1. Samples of medicinal products are sent to the state quality control of medicinal products with a cover letter indicating the type of quality control of medicinal products, with a quality certificate of the medicinal product of the manufacturer and an act of sampling of medicinal products.

Samples of medicinal products sent for selective or re-selective quality control of medicinal products must be accompanied by a certified copy of the certificate of conformity of the medicinal product with the analysis protocol.

Samples of substances for quality examination for the purpose of registration of a medicinal product are sent with a cover letter indicating the type of quality control of medicinal products, and a certificate of quality of the medicinal product of the manufacturer.

6.3.2. Samples of medicines for injections and eye drops sent for preliminary quality control of medicines, in addition to the documents listed in clause 2.3.1 of this Procedure, must be accompanied by the results of checking the quality of these medicines in terms of "Particles". The results of such a check are presented by the territorial authorities for quality control of medicines.

6.3.3. Samples of substances from which medicinal products are produced, submitted for preliminary and selective quality control of medicinal products (for domestic manufacturers), must be accompanied by a quality certificate issued based on the results of quality control of the substance when it enters production at the manufacturing enterprise for all indicators of the regulatory document, original or certified copy of the quality certificate of the medicinal product of the manufacturer; for foreign substances, the dates of manufacture and expiration date of the substance must be additionally indicated.

6.3.4. Substance standard samples submitted in accordance with clause 2.2.3 of this Procedure must be accompanied by the original or a certified copy of the manufacturer's medicinal product quality certificate.

6.4. Storage of drug samples

Samples of medicines remaining after the state quality control of medicines are stored for at least 6 months, after which samples of medicines that do not meet the requirements of the state quality standard are subject to destruction in the prescribed manner. Samples of medicines that meet the requirements of state quality standards are returned to manufacturing enterprises at their written request or used for research purposes or donated to healthcare institutions at their written request.

Annex 1. Decision on the release of medicines

Attachment 1
to the Implementation Procedure
state control
drug quality
on 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__

SOLUTION
on the release of medicines

______________________________________
Business name

Legal address: ________________________ phone ___ fax ____ e-mail ___________

Manufacturer's address: ________________________________________________________

The contact person: __________________________________________________________

Head of the enterprise __________________ signature ______________ seal

The Ministry of Health of the Russian Federation confirms that these medicines have passed the procedure of state control of quality, efficacy, safety and can be allowed (name of the enterprise) to be released into the sphere of circulation of medicines in the Russian Federation.

Appendix 2. The act of sampling medicines

Annex 2

to the Implementation Procedure
state control
drug quality
on the territory of the Russian Federation

from "__" __________ ____

The text of the document is verified by:
Bulletin of regulations
federal bodies
executive power,
No. 29, 21.07.2003