TOPIC 16. HYGIENIC ASSESSMENT OF BUILDING, LAYOUT AND OPERATION OF WHOLESALE PHARMACEUTICAL ORGANIZATIONS (PHARMACY WAREHOUSES) AND CONTROL AND ANALYTICAL LABORATORIES

Purpose of the lesson: students' mastery of the basic hygienic requirements for the placement, layout, improvement and operating mode of wholesale pharmaceutical organizations (pharmacy warehouses) and control and analytical laboratories (CAL) using the example of analyzing the project of a pharmacy warehouse and CAL.

In preparation for the lesson, students must work through the following: theoretical issues.

1. Hygienic requirements for the selection of territory, placement, layout and sanitary improvement of pharmaceutical warehouses. Industrial hazards, measures to create an optimal sanitary and hygienic regime.

2. Hygienic requirements for the placement, layout, and sanitary improvement of the premises. Occupational hazards, prevention of occupational diseases.

After mastering the topic the student must know:

Determination and assessment of the layout of pharmaceutical warehouse premises, KAL;

Determination and hygienic assessment of water supply, ventilation, heating, lighting in a pharmaceutical warehouse, in the industrial premises;

be able to:

Understand design materials for the construction or reconstruction of a pharmaceutical warehouse and distribution facilities;

Use the main regulatory documents and reference information sources relating to the organization and control of the sanitary condition and anti-epidemic regime of the pharmacy warehouse, CAL;

Training material for completing the assignment

Basic hygienic requirements for the layout and operation of pharmaceutical warehouses

Wholesale pharmaceutical organizations (medicine wholesale trade enterprises) must have the necessary premises, equipment and inventory that ensure, in accordance with the requirements of standards, the preservation of the quality and safety of medicines during their storage and sale, appropriate conditions for wholesale trade (in accordance with OST 91500.05.0005- 2002 “Rules for wholesale trade in medicines. Basic provisions”, approved by Order of the Ministry of Health of the Russian Federation dated March 15, 2002, as amended by orders of the Ministry of Health of the Russian Federation dated March 21, 2003? 122, dated March 28, 2003?

A wholesale pharmaceutical organization must have storage and administrative premises, combined in one building or located separately (hereinafter referred to as the warehouse).

The warehouse can be located in a separate non-residential building, a building for industrial purposes (medical or pharmacy, except health care facilities) or in non-residential premises of residential buildings. In this case, the warehouse must be isolated from other buildings, have a separate entrance, access area, and a ramp for unloading goods.

When a warehouse is located in a medical or pharmacy building, administrative and amenity premises may be shared. If a warehouse is located in non-residential premises of residential buildings, loading and unloading of medical products should not be carried out under the windows of the apartments.

Warehouses must have power supply, heating, water supply, sewerage, and supply and exhaust ventilation systems.

Warehouses of pharmaceutical wholesalers must be isolated and specially equipped to ensure the storage and integrity of medicines, taking into account their physicochemical, pharmacological and toxicological properties, as well as the requirements of medicines quality standards and the State Pharmacopoeia.

Premises for storing narcotic drugs, psychotropic, poisonous and potent substances must comply with established requirements.

Warehouse premises must be functionally interconnected according to their purpose: reception, storage, order picking and goods release.

The area of ​​warehouse premises for the main production purpose must correspond to the volume of stored goods per unit of warehouse area, but not less than 150 m2, including:

Product acceptance area;

Area for the main storage of medicines;

Premises for medicines requiring special storage conditions;

Expeditionary.

The product acceptance area must be separated from the storage area.

The total area of ​​administrative and utility premises depends on the number of personnel and is calculated in accordance with current norms and rules, but not less than 34 m2, including auxiliary warehouse premises intended to accommodate the management apparatus, household buildings, for example, office premises of the warehouse management apparatus, points food, health center, sanitary facilities, lobbies, staircases, vestibules.

Table 62. Composition and dimensions of pharmaceutical warehouse premises

The finishing of the premises (internal surfaces of walls, ceilings) must be smooth and allow for wet cleaning. The floors of warehouses must have a dust-free coating that is resistant to mechanization and wet cleaning using disinfectants; the use of unpainted wooden surfaces is not allowed. Finishing materials for premises must comply with established requirements.

The warehouse must have a special isolated place for storing detergents and disinfectants, equipment and materials used in cleaning premises and processing equipment, and a dressing room. In the dressing room, outerwear and shoes are stored separately from spare clothes and shoes.

Rice. 14. State Unitary Enterprise “Pharmacy Warehouse? 1"

The pharmacy warehouse must be equipped with equipment and inventory in accordance with the functions performed (Fig. 14):

Racks, pallets, storage racks for medicines;

Refrigeration chambers for storing thermolabile medicines;

Means of mechanization for loading and unloading operations;

Instruments for recording air parameters (thermometers, hygrometers or psychrometers);

Lockable metal cabinets and safes for storing certain groups of medications, accounting documentation and reference literature;

Cabinets for storing outer and special clothing, shoes in the dressing room;

Disinfectants and household equipment to ensure sanitary conditions.

The land plot must meet hygienic requirements: be isolated from other buildings, have a slight slope to drain surface water, the groundwater level should not be higher than 1.5 m from the ground surface. On the territory of the pharmaceutical warehouse there should be an area for solid waste and storage of containers, and a garage. Access roads must have a hard surface (asphalt, concrete).

With the exception of some special-purpose premises, pharmaceutical warehouse premises must have an air temperature of 18-20? C, humidity 40-60%, air speed - 0.1-0.2 m/s.

Natural and artificial ventilation must be provided in all premises of the pharmaceutical warehouse. Natural air exchange is ensured by transoms and ventilation ducts. Artificial ventilation, supply and exhaust, must ensure an air exchange rate of 3 for inflow and 4 for exhaust. Workplaces for packaging bulk and volatile medicines must be equipped with local exhaust ventilation systems (fume hoods, exhaust hoods).

All premises of the pharmaceutical warehouse (with the exception of basements and sanitary rooms) must have natural and artificial lighting. KEO is allowed no lower than 0.5%. With artificial lighting, the illumination in workplaces where work involves visual strain should be at least 300-500 lux.

Pharmacy warehouse personnel must be provided with special clothing and personal protective equipment (goggles, respirators, etc.).

Basic hygienic requirements for the layout and operating mode of control and analytical laboratories

Laboratories eligible for accreditation include regional (territorial) control and analytical laboratories, departments (centers) for quality control of medicines and other similar units of territorial executive authorities in the field of healthcare and pharmaceutical activities of the constituent entities of the Federation, control and analytical laboratories at pharmaceutical warehouses (wholesale pharmaceutical organizations), as well as analytical laboratories of research institutes and higher educational institutions of pharmaceutical profile, KAL accreditation of technical control departments of chemical and pharmaceutical industry enterprises is allowed, provided that when carrying out this type of activity they will not exercise quality control of the products produced by this enterprise.

The laboratory must be independent in its activities from legal entities of all organizational and legal forms and individuals involved in the development, manufacture and sale of medicines.

The environment in which the analyzes are carried out should not affect the results of the analyzes and the measurement error.

Premises for conducting analyzes must correspond to the production area and the conditions provided in them (temperature, humidity, air purity, lighting, sound and vibration insulation, protection from radiation of magnetic, electric and other physical fields, supply of electricity, water, air, heat, refrigerants, etc.), the requirements of the applied analysis methods, sanitary standards and regulations, labor safety and environmental protection requirements. At the same time, the following must be ensured: rational interconnection of premises, favorable production conditions for monitoring the quality of medicines, the use of safe working methods, rational placement of the necessary equipment and devices.

Name of premises
Analytical room
Optical
Reagent storage room
Room for bacteriological analysis
Biological analysis room
Methodical office
Manager's office and office
Basement (room for flammable substances)
Cellar for biological material

Laboratory work “Hygienic assessment of the development, layout and operating mode of wholesale pharmaceutical organizations (pharmacy warehouses) and control and analytical laboratories”

Student assignments

Solve a situational problem: analyze the master plan and design of the pharmacy warehouse and laboratory, an explanatory note to the project and give a hygienic conclusion.

Working method

1. Give a hygienic assessment of the land plot of the pharmaceutical warehouse and its development:

Determine the sufficiency of the area of ​​the land plot, its topography, the nature of the soil, the level of groundwater; building density of the pharmacy warehouse site and percentage of landscaping.

2. Give a hygienic assessment of the layout of the premises of a pharmaceutical warehouse:

Assess the compliance of the composition and area of ​​individual premises of the pharmaceutical warehouse with the established requirements;

3. Give a hygienic assessment of the sanitary arrangement of the pharmaceutical warehouse:

4. Give a hygienic assessment of the layout of the premises:

Assess the compliance of the composition and area of ​​individual CAL premises with the established requirements;

5. Give a hygienic assessment of sanitary facilities

Assess water supply, ventilation, lighting of premises: ensuring the required frequency of air exchange, the required temperature conditions, compliance of natural and artificial lighting in the premises with hygienic standards.

Introduction

Doctors and pharmacists have joint activities, which are determined by regional and regional programs to provide the population with free or discounted funds. Pharmacists keep records of patients assigned to the pharmacy, and inform doctors if a patient on the list does not arrive.

To supply pharmacies with medicines, there is a network of pharmaceutical distributors who have modernly organized pharmacy warehouses for storing medical goods.

A modern pharmacy warehouse is a complex technical structure that has a certain structure. Warehouse premises are located in such a way as to ensure functional interconnection between all areas of the warehouse. pharmacy warehouse medicinal documentation

Tasks and functions of a pharmacy warehouse

A pharmacy warehouse is a room specifically designed for storing medicines and medications. In addition to storage, a pharmacy warehouse can also purchase and sell medical drugs and products, as well as medical products, pharmaceutical equipment and supplies that meet all quality requirements under current legislation.

In accordance with the main objectives, the pharmacy warehouse performs the following functions:

• 1. concludes contracts with suppliers;
• 2. purchases pharmaceutical goods and medical products;
• 3. conducts claims and lawsuits, imposes penalties on suppliers in case of violation of contractual obligations;
• 4. accepts medicines and medical products from suppliers in terms of quality, quantity and cost;
• 5. organizes the storage of medicines and medical products, taking into account their physical and chemical properties and the requirements of the Global Fund;
• 6. ensures safety, accepts orders from pharmacies, treatment-and-prophylactic and other institutions, as well as pharmaceutical enterprises for packaging, completing and timely delivery of medicines and medical products according to orders;
• 7. organizes strict adherence to the procedure for accounting and dispensing pharmaceutical, parapharmaceutical and other goods;
• 8. exercises control at all stages of production activities;
• 9. ensures control over expiration dates and stay in the warehouse, shipment of medicines and medical products, their timely sale taking into account expiration dates, as well as compliance with price discipline during delivery and settlements with suppliers and consumers;
• 10. complies with labor protection and safety requirements.

To perform the main functions, managers and personnel of a pharmacy warehouse are required to follow the regulatory documents governing its activities, study supply and demand in the pharmaceutical market, and comply with the certification and quality control procedures.

A pharmacy warehouse can be located in a separate non-residential building, an industrial building or in non-residential premises of residential buildings, while the warehouse must be isolated from other premises, have a separate entrance, access area and ramp for unloading goods. If the warehouse is located in non-residential premises of residential buildings It is prohibited to load and unload medical products under the windows of the apartment building.

The military pharmaceutical warehouse is a complex technical burning sensation that has a certain structure. Warehouse premises are located in such a way as to ensure a functional relationship between the areas of loading and unloading, receiving, storing, picking and issuing orders.
W During loading and unloading operations, incoming cargo must be protected from atmospheric precipitation and exposure to low and high temperatures.
The facility for receiving pharmaceutical products can occupy a separate warehouse space or be a dedicated area of ​​the storage area. Its main functions are receiving cargo in terms of quantity, completeness and quality; checking accompanying documentation; conducting Claims work; distribution of goods to storage locations in accordance with the methods and conditions of storage of individual groups of goods used in the warehouse. In addition, the receiving area may be entrusted with the functions of selecting samples of goods for quality analysis; packaging cargo, assembling large units for storage in a warehouse, as well as disassembling the latter for the same purpose; temporary storage (accumulation) of incoming cargo for prompt distribution at the main warehouse areas .
Medicines in damaged packaging that do not have a certificate of conformity, do not meet the order, do not have the necessary accompanying documentation, as well as those for which there is an assumption of their contamination, are appropriately marked and placed in a specially designated (quarantine) area separately from other medicines until they are identified or destroyed in the prescribed manner. ^
Medicines that require special storage conditions must be immediately identified and stored in the prescribed manner.
The storage facility allows you to implement the functions of a pharmacy warehouse related to ensuring the safety of goods (compliance with storage conditions, monitoring expiration dates, integrity of secondary packaging, etc.). The cargo capacity of the storage area depends not only on the size, but also on the chosen storage method - racking, on pallets, in containers, etc. Two indicators play a role here, the warehouse space utilization ratio (an indicator characterizing the ratio of the area occupied directly by cargo to the total cargo area) and the warehouse volume utilization ratio (an indicator characterizing the ratio of the volume occupied by cargo to the cargo volume of the storage area). Depending on the chosen storage method and the use of this or that equipment, it is possible to achieve optimal use of the cargo storage area, taking into account their further processing. As a rule, orders are also collected in the storage areas of the pharmaceutical warehouse and transferred to the forwarding department.
The expedition area is a separate room designed to record shipped cargo, their temporary storage, and preparation of accompanying documentation.
Warehouses must have power supply, heating, water supply, sewerage, and supply and exhaust ventilation systems. The finishing of the premises is carried out using materials that allow wet cleaning. Floor coverings are subject to additional requirements regarding their resistance to the effects of mechanization, wet cleaning using disinfectants, and the absence of dust-forming effects. In the warehouse, it is necessary to allocate a special isolated place for storing detergents and disinfectants, equipment and materials used in cleaning premises and processing equipment, and a dressing room. In the dressing room, outer clothing and shoes are stored separately from removable special clothing and shoes.
The pharmaceutical warehouse, in accordance with the volume of work and the size of the warehouse space, is equipped with equipment and inventory for recording air parameters (thermometers, hygrometers or psychrometers, which are placed on the inner wall of all rooms where drugs are stored, away from heating devices at a height of 1.5- 1.7 m from the floor and at a distance of at least 3 m from the doors. The indicators of these devices are recorded daily in a special journal or card. Devices must be certified and calibrated in the prescribed manner);
. packaging of cargo (pallet wrapper), automation of cargo accounting (reading devices __ contact CCD scanner, laser scanner, data collection terminals, etc., computer equipment), storage of outerwear and special clothing and shoes in the dressing room (closets); ensuring sanitary conditions (disinfectants, household equipment - buckets, brushes, vacuum cleaner, etc.).
In order to ensure the quality of the technological operations of the pharmaceutical warehouse and the goods stored there, access of unauthorized persons to the production premises intended for the reception, sorting, storage, packaging, dispensing and shipment of drugs is prohibited. In addition, the Wholesale Trade Rules provide for the enterprise to conduct regular internal inspections, the frequency of which is determined by the management of the wholesale organization. Inspections can be carried out by employees of a drug wholesale trade enterprise, who carry them out in accordance with functional and job descriptions, or by other employees by order of the manager, as well as independent experts. The results of inspections are recorded and brought to the attention of personnel.
The manager responsible for the operation of the warehouse and his deputies must have appropriate education and practical experience in the field of circulation of medicines.
The head of a drug wholesale trade enterprise from the management team appoints a person responsible for compliance with the rules of drug wholesale trade (quality officer). The functional responsibilities of the quality commissioner at the enterprise are established in accordance with the Level of Responsibility by analogy with the tasks of Quality Commissioners in various areas of healthcare, approved by the OST “Procedure for monitoring compliance with the requirements of regulatory documents of the standardization system in healthcare

A pharmacy warehouse is an organization that is engaged in the wholesale trade of drugs, medical devices and other pharmaceutical products.

In the process of movement of goods in a pharmacy warehouse from manufacturer to consumer, 80-90% is spent on storing goods.

The organization of wholesale trade is carried out in accordance with the OST “Rules for Trade in Medicines” approved by Order N80.

Organizational structure of the warehouse organization:

1.Management of the pharmacy warehouse.

2.Trading department (concluding contracts with suppliers)

3.Sales department (sells goods to customers)

4.Planning department (plans the work of the pharmacy assortment)

5.Acceptance department (receives goods)

6. Storage department: pharmaceutical drugs; Narcotic drugs; Dressings; Pharmacy equipment.

7. Forwarding (carries out delivery of completed goods)

Tasks of the pharmacy warehouse:

1. Reception of goods from suppliers.

2.Organization of storage of goods.

3. Completion of goods.

4. Release of goods.

Warehouse functions:

1. Concluding contracts with suppliers.

2.Purchase of pharmaceutical goods and medical devices.

3. Reception of drugs and medical devices according to quality, quantity, cost.

4.Storage of goods taking into account physical and chemical properties.

5. Compliance with the procedure for accounting and dispensing of drugs.

State regulation of labor relations. Work time. Time relax. The procedure for granting vacations.

WORK TIME- the time during which the employee, in accordance with the internal labor regulations and the terms of the employment contract, must perform labor duties (labor function), as well as other periods of time in accordance with the Labor Code of the Russian Federation, other Federal Laws and other regulatory legal acts of the Russian Federation.

Normal duration working hours cannot exceed 40 hours per week. The employer is obliged to keep records of the time actually worked by each employee (Article 91 of the Labor Code of the Russian Federation).

In accordance with Art. 92 of the Labor Code of the Russian Federation, reduced working hours are established:

for workers under 16 years of age - no more than 24 hours per week;

for workers aged 16 to 18 years - no more than 35 hours per week;

for workers who are disabled people of group I or II - no more than 35 hours per week;

for workers engaged in work with hazardous and (or) dangerous UT, - no more than 36 hours per week in the manner established by the Government of the Russian Federation, taking into account the opinion of the Russian Tripartite Commission for the Regulation of Social and Labor Relations.

The length of working time for students of educational institutions under the age of 18, who work during the academic year in their free time from school, cannot exceed half of the norms established by Art. 92 Labor Code of the Russian Federation. Duration of work (shift) at night is reduced by 1 hour

TIME RELAX- time during which the employee is released from performing work duties and which he can use at his own discretion. The legal norms regulating the V. o. are set out in section. V Labor Code of the Russian Federation. Types of V. o. are: breaks during the working day (shift); daily (between shifts) rest; weekends (weekly uninterrupted rest); non-working holidays; vacation.

Breaks during the working day(shifts) are divided into breaks for rest and food (Article 108 of the Labor Code of the Russian Federation) and special breaks for heating and rest (Article 109 of the Labor Code of the Russian Federation). Rest and meal breaks are not included during working hours and therefore are not payable (see Work breaks).

Weekend (weekly uninterrupted rest) are provided to all employees: with a 5-day work week - 2 days off per week, with a 6-day work week - 1 day off.

The duration of weekly continuous rest cannot be less than 42 hours (Article 110 of the Labor Code of the Russian Federation). It is calculated from the end of work on the eve of the day off until the start of work on the next day after the day off. May be different, because it depends on the type of work week (5- or 6-day), shift schedule, length of the working day, etc.

The general day off is Sunday. With a 5-day working week, the 2nd day off is established by a collective agreement or the internal labor regulations of the organization. Both days off are usually provided in a row. In cases where the day of weekly continuous rest coincides with a non-working holiday, it is transferred to the next working day after the holiday.

The Labor Code provides that the right to use vacations for the first working year arises for the employee after six months of his continuous work in this organization. By agreement of the parties, paid leave may be granted to the employee before the expiration of six months. According to Art. 71 of the Labor Code, leave was granted after 11 months of continuous work, and for employees transferred from one organization to another, it could be granted before the expiration of 11 months of work after the transfer. Moreover, if before the transfer the employee did not work for 11 months in one organization, then he can be granted leave after a total of 11 months of work before and after the transfer. Detailed regulation and restriction of the rights of the parties to the employment contract entailed violations, and in practice these prohibitions were often not observed.

The solution proposed in the Labor Code is much preferable; it provides the parties with greater freedom to independently (contractually) regulate labor relations.

Unlike the Labor Code, the new Code in Art. 122 stipulates who can legally take leave before the end of the first six months of continuous employment.

Leave for the second and subsequent years of work can be granted at any time of the working year in accordance with the order of provision of annual paid leave established in the given organization. At the same time, the possibility of granting two vacations for different working years in one calendar year is not excluded.

This means that annual paid leave is provided for each working year (12 months). The six-month period is the period when the employee becomes entitled to use his vacation, but he is only entitled to one vacation per working year.

The first working year is calculated from the date of entry into work in this organization, and subsequent ones - from the day following the end of the previous working year.

Answer.6. Federal Law of the Russian Federation “On the circulation of drugs”. Basic concepts of the Federal Law of the Russian Federation “On the circulation of drugs”.

1. This Federal Law regulates relations arising in connection with circulation - development, preclinical studies, clinical trials, examination, state registration, standardization and quality control, production, manufacturing, storage, transportation, import into the territory of the Russian Federation, export from territory of the Russian Federation, advertising, release, sale, transfer, use, destruction of medicines.

2. This Federal Law establishes the priority of state control of the safety, quality and effectiveness of medicines during their circulation.

For the purposes of this Federal Law, the following basic concepts are used:

1) medicines- substances or combinations thereof that come into contact with the human or animal body, penetrate the organs, tissues of the human or animal body, used for prevention, diagnosis (except for substances or their combinations that do not come into contact with the human or animal body), treatment of disease, rehabilitation, for the preservation, prevention or termination of pregnancy and obtained from blood, blood plasma, organs, tissues of the human or animal body, plants, minerals by synthesis methods or using biological technologies. Medicines include pharmaceutical substances and drugs;

2) pharmaceutical substances- medicinal products in the form of active substances of biological, biotechnological, mineral or chemical origin, possessing pharmacological activity, intended for the production, manufacture of medicinal products and determining their effectiveness;

3) excipients- substances of inorganic or organic origin used in the production process, manufacturing of medicinal products to give them the necessary physical and chemical properties;

4) medications- medicines in the form of dosage forms used for the prevention, diagnosis, treatment of disease, rehabilitation, for the preservation, prevention or termination of pregnancy;

5) dosage form- the state of the medicinal product, corresponding to the methods of its administration and use and ensuring the achievement of the required therapeutic effect;

6) list of vital and essential medications- a list of medicines for medical use, annually approved by the Government of the Russian Federation, that meet priority healthcare needs for the prevention and treatment of diseases, including those that predominate in the structure of morbidity in the Russian Federation;

7) immunobiological drugs- medicinal products of biological origin intended for immunological diagnosis, prevention and treatment of diseases;

8) narcotic drugs- medicinal preparations and pharmaceutical substances containing narcotic drugs and included in the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the Single Convention on Narcotic Drugs of 1961 of the year;

9) psychotropic drugs- medicinal preparations and pharmaceutical substances containing psychotropic substances and included in the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the Convention on Psychotropic Substances of 1971 ;

10) radiopharmaceuticals- medicines that contain one radionuclide or several radionuclides (radioactive isotopes) in a ready-to-use form;

11) original medicine- a medicinal product containing a pharmaceutical substance obtained for the first time or a new combination of pharmaceutical substances, the effectiveness and safety of which are confirmed by the results of preclinical studies of drugs and clinical studies of drugs;

12) generic medicinal product- a medicinal product containing the same pharmaceutical substance or a combination of the same pharmaceutical substances in the same dosage form as the original medicinal product, and put into circulation after the original medicinal product was put into circulation;

13) medicinal plant materials- fresh or dried plants or their parts used for the production of medicines by organizations - manufacturers of medicines or the manufacture of medicines by pharmaceutical organizations, veterinary pharmacy organizations, individual entrepreneurs with a license for pharmaceutical activities;

14) medicinal herbal preparation- a medicinal product produced or prepared from one type of medicinal plant raw material or several types of such raw materials and sold prepackaged in secondary (consumer) packaging;

15) homeopathic medicine- a medicinal product produced or manufactured using special technology;

16) international nonproprietary name of the medicinal product- name of the pharmaceutical substance recommended by the World Health Organization;

17) trade name of the medicinal product- name of the medicinal product assigned by its developer;

18) general pharmacopoeial monograph- a document approved by the authorized federal executive body and containing a list of quality indicators and (or) quality control methods for a specific dosage form, medicinal plant raw materials, descriptions of biological, biochemical, microbiological, physicochemical, physical, chemical and other methods of analysis of a medicinal product for medical use, as well as requirements for reagents, titrated solutions, and indicators used for this analysis;

19) pharmacopoeial monograph- a document approved by the authorized federal executive body and containing a list of quality indicators and methods for quality control of a medicinal product for medical use;

20) regulatory documentation- a document containing a list of quality indicators of a medicinal product for medical use determined based on the results of relevant examinations, methods for controlling its quality and established by its manufacturer;

21) normative document- a document containing a list of quality indicators and (or) quality control methods for the dosage form determined based on the results of relevant examinations, descriptions of biological, biochemical, microbiological, physicochemical, physical, chemical and other methods of analysis of medicinal products for veterinary use, requirements for those used in for the purpose of carrying out this analysis, reagents, titrated solutions, indicators and established by its manufacturer;

22) quality of the medicinal product - compliance of the medicinal product with the requirements of the pharmacopoeial monograph or, in the absence of it, regulatory documentation or regulatory document;

23) safety of a medicinal product - characteristics of a medicinal product based on a comparative analysis of its effectiveness and risk of harm to health;

24) effectiveness of a medicinal product - a characteristic of the degree of positive effect of the medicinal product on the course, duration of the disease or its prevention, rehabilitation, on the preservation, prevention or termination of pregnancy;

25) batch of a medicinal product - the amount of a medicinal product produced as a result of one technological cycle by its manufacturer;

26) registration certificate of a medicinal product - a document confirming the fact of state registration of the medicinal product;

27) registration number - a code designation assigned to a medicinal product during its state registration;

28) circulation of medicines - development, preclinical studies, clinical studies, examination, state registration, standardization and quality control, production, manufacturing, storage, transportation, import into the territory of the Russian Federation, export from the territory of the Russian Federation, advertising, release, sales, transfer, use, destruction of medicines;

29) subjects of circulation of medicines - individuals, including individual entrepreneurs, and legal entities carrying out activities in the circulation of medicines;

30) medicinal product developer - an organization that has rights to the results of preclinical studies of a medicinal product, clinical trials of a medicinal product, as well as to the production technology of a medicinal product;

31) production of medicines - activities for the production of medicines by organizations - manufacturers of medicines at one stage, several or all stages of the technological process, as well as for the storage and sale of produced medicines;

32) manufacturer of medicines - an organization engaged in the production of medicines in accordance with the requirements of this Federal Law;

33) pharmaceutical activities - activities that include wholesale trade in medicines, their storage, transportation and (or) retail trade in medicines, their dispensing, storage, transportation, manufacturing of medicines;

34) organization of wholesale trade in medicines - an organization engaged in wholesale trade in medicines, their storage, transportation in accordance with the requirements of this Federal Law;

35) pharmacy organization - an organization, a structural unit of a medical organization that carries out retail trade in medicines, storage, manufacture and dispensing of medicines for medical use in accordance with the requirements of this Federal Law;

36) veterinary pharmacy organization - an organization, a structural unit of a veterinary organization that carries out retail trade in medicinal products, storage, manufacture and dispensing of medicinal products for veterinary use in accordance with the requirements of this Federal Law;

37) counterfeit medicinal product - a medicinal product accompanied by false information about its composition and (or) manufacturer; 38) substandard medicinal product - a medicinal product that does not meet the requirements of a pharmacopoeial article or, in the absence of one, the requirements of regulatory documentation or a regulatory document;

39) counterfeit medicinal product - a medicinal product in circulation in violation of civil legislation;

40) preclinical research of a medicinal product - biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other studies of a medicinal product through the use of scientific evaluation methods in order to obtain evidence of the safety, quality and effectiveness of the medicinal product;

41) clinical trial of a medicinal product - the study of the diagnostic, therapeutic, preventive, pharmacological properties of a medicinal product during its use in humans, animals, including the processes of absorption, distribution, change and excretion, through the use of scientific evaluation methods in order to obtain evidence of safety, the quality and effectiveness of the medicinal product, data on adverse reactions of the human or animal body to the use of the medicinal product and the effect of its interaction with other drugs and (or) food products, feed;

42) multicenter clinical trial of a medicinal product for medical use - a clinical trial of a medicinal product for medical use, conducted by the developer of the medicinal product in two or more medical organizations according to a single protocol for the clinical trial of the medicinal product; 43) international multicenter clinical trial of a medicinal product for medical use - a clinical trial of a medicinal product for medical use, conducted by the developer of the medicinal product in various countries according to a unified clinical trial protocol for the medicinal product;

44) post-registration clinical trial of a medicinal product for medical use - a clinical trial of a medicinal product for medical use, conducted by the manufacturer of a medicinal product, the civil circulation of which is carried out after state registration, for the purpose of additional collection of data on its safety and effectiveness, expanding the indications for use of this medicinal product , as well as identifying adverse reactions of patients to its action;

45) study of bioequivalence of a medicinal product - a type of clinical study of a medicinal product, which is carried out to determine the rate of absorption and excretion of a pharmaceutical substance, the amount of a pharmaceutical substance reaching the systemic bloodstream, and the results of which allow us to draw a conclusion about the bioequivalence of the reproduced medicinal product in a certain dosage form and dosage the corresponding original medicinal product;

46) study of therapeutic equivalence of medicinal products - a type of clinical study of medicinal products, which is carried out to identify the same properties of medicinal products of a certain dosage form, as well as the presence of the same indicators of safety and effectiveness of medicinal products, the same clinical effects when used;

47) protocol for a clinical trial of a medicinal product - a document that defines the goals, forms of organization and methodology for conducting a clinical trial, statistical methods for processing the results of such a study and measures to ensure the safety of individuals participating in the clinical trial of a medicinal product;

48) investigator’s brochure - a summary of the results of a preclinical study of a medicinal product and a clinical trial of a medicinal product for medical use;

49) patient information sheet - a document that contains in an accessible form information relating to the ongoing clinical trial of a medicinal product, and in written form the patient’s voluntary consent to participate in a clinical trial of a medicinal product after familiarization with the features of the clinical trial that are important for the expression of such consent ;

50) side effect - a reaction of the body that occurs in connection with the use of a medicinal product in doses recommended in the instructions for its use for the prevention, diagnosis, treatment of a disease or for rehabilitation;

51) serious adverse reaction - an undesirable reaction of the body associated with the use of a medicinal product, leading to death, congenital anomalies or developmental defects, or posing a threat to life, requiring hospitalization or leading to permanent loss of ability to work and (or) disability;

52) unexpected undesirable reaction - an undesirable reaction of the body (including those associated with the use of a medicinal product in accordance with the instructions for its use), the nature and severity of which do not correspond to the information about the medicinal product contained in the instructions for its use;

53) prescription for a medicinal product - a written prescription of a medicinal product in the prescribed form, issued by a medical or veterinary worker entitled to do so, for the purpose of dispensing the medicinal product or its manufacture and dispensing;

54) requirement of a medical organization, veterinary organization - a document of the established form, which is issued by a medical or veterinary worker who has the right to do so, and contains in writing an instruction to the pharmacy organization on the dispensing of a medicinal product or on its manufacture and on dispensing to ensure the treatment process in medical organization, veterinary organization.

A pharmacy warehouse is organized and is subordinate to the regional or city government. The pharmacy warehouse has its own working capital and is a self-supporting enterprise.

The pharmacy warehouse is responsible for the following work:

1) acceptance of medical goods from suppliers;

2) qualitative and quantitative verification of received goods;

3) proper storage of goods depending on their physical and chemical properties;

4) distribution of medical goods to pharmacies, production enterprises of the regional administration, treatment and prevention and other institutions as directed by the regional pharmacy administration;

5) delivery of goods to the pharmacy network of the region using our own vehicles.

Warehouse structure. Due to the fact that the premises of many pharmacy warehouses do not always allow these recommendations to be fully implemented, the number of departments in warehouses of the same categories varies noticeably.

In accordance with the recommendations, in category I pharmacy warehouses, in addition to the receiving department and the expedition department, the following operational departments are provided: dry medicines; liquid medicines; poisonous medicines; finished medicines; medicines in ampoules; bacterial preparations and blood substitutes; antibiotics, vitamins and their preparations; flammable substances and compressed gases, disinfectants; dressing materials; sanitary hygiene and patient care products; pharmaceutical equipment, spectacle optics and medical instruments; pharmaceutical packaging and auxiliary materials; prescription glass and containers.

In total, category I warehouses have 16 departments; in warehouses of category II - 15, category III - 13, category IV - 10 and in category V warehouses - 9 departments. Additionally, warehouses of all categories must have a packaging room for packaging dry and liquid medicines, a washing and packaging room.

In order to unify the storage of goods and quickly fulfill orders, a unified classification of groups of medical goods according to the operational departments of pharmacy warehouses has been developed. In particular, it is recommended to store potent List B drugs, photosensitive, strong-smelling, volatile, hygroscopic, crystalline hydrates, coloring, weight and tablet drugs in the dry medicine department. All ready-made medications and hormonal preparations should be stored in the finished medicines department. The corresponding groups of goods are stored in other departments.

In accordance with the developed structure of warehouses, a list of positions in the pharmaceutical warehouse is recommended, which should be filled by persons with higher or secondary pharmaceutical education.

In terms of organizational structure, many regional pharmacy warehouses are quite complex farms. In addition to operational departments, the structure includes various services: transport, security, machine counting bureau, accounting, etc.

The activities of heads of departments and various services are regulated by relevant orders and regulations, as well as job descriptions approved by the warehouse management.

A pharmaceutical warehouse can be located in a separate non-residential building, an industrial building or in non-residential premises of residential buildings, while the warehouse must be isolated from other premises, have a separate entrance, an access area and a ramp for unloading goods.

If a warehouse is located in non-residential premises of residential buildings, it is prohibited to load and unload medical products under apartment windows.

A modern pharmacy warehouse is a complex technical structure that has a certain structure.

Warehouses are located in such a way as to ensure a functional relationship between the areas of loading and unloading, receiving, storing, picking and issuing orders.

When carrying out loading and unloading operations, incoming cargo must be protected from precipitation and exposure to low and high temperatures. The pharmaceutical products receiving area may occupy a separate warehouse space or be a dedicated area of ​​the storage area.

Its main functions are receiving cargo in terms of quantity, completeness and quality; checking accompanying documentation; conducting claims work; distribution of goods to storage locations in accordance with the methods and conditions of storage of individual groups of goods used in the warehouse.

In addition, the acceptance area may be assigned the functions of sampling goods for quality analysis; packaging of cargo, completing enlarged units for storage in a warehouse, as well as disassembling the latter for the same purpose; temporary storage (accumulation) of incoming cargo for prompt distribution at the main warehouse areas.

Medicines in damaged packaging that do not have a certificate of conformity, do not meet the order, do not have the necessary accompanying documentation, as well as those for which there is an assumption of their contamination, are appropriately marked and placed in a specially designated (quarantine) area separately from other medicines until they are identified or destroyed in the prescribed manner.

Medicines requiring special storage conditions must be immediately identified and stored in the prescribed manner. The storage area allows you to implement the functions of a pharmacy warehouse related to ensuring the safety of goods (compliance with storage conditions, monitoring expiration dates, integrity of secondary packaging, etc.).

The cargo capacity of the storage area depends not only on the size, but also on the chosen storage method - racking, on pallets, in containers, etc. As a rule, in the storage areas of the pharmaceutical warehouse, orders are also collected and transferred to the forwarding department.

The expedition area is a separate room designed for accounting for shipped cargo, their temporary storage, preparation of accompanying documentation, etc. Warehouses must have power supply, heating, water supply, sewerage, and supply and exhaust ventilation systems.

The finishing of the premises is carried out using materials that allow wet cleaning. Floor coverings are subject to additional requirements regarding their resistance to the effects of mechanization, wet cleaning using disinfectants, and the absence of dust-forming effects.

In the warehouse, it is necessary to allocate a special isolated place for storing detergents and disinfectants, equipment and materials used in cleaning premises and processing equipment, and a dressing room. In the dressing room, outerwear and shoes are stored separately from removable special clothing and shoes.

Pharmacy warehouse in accordance with the volume of work, the size of the warehouse space equipped with equipment and supplies For:

• carrying out unloading and loading operations (loaders, forklifts, trolleys, stackers);
• ensuring the storage of goods (racks, pallets, refrigeration equipment, air conditioners, metal cabinets and safes for storing certain groups of drugs, accounting documentation and reference literature);
• registration of air parameters (thermometers, hygrometers or psychrometers, which are placed on the inner wall of all rooms where drugs are stored, away from heating devices at a height of 1.5-1.7 m from the floor and at a distance of at least 3 m from the doors. Indicators of these devices are recorded daily in a special journal or card; devices must be certified and calibrated in the prescribed manner);
• packaging of goods (pallet wrapper);
• automation of cargo accounting (reading devices - scanner, laser scanner, data collection terminals, computer equipment);
• storing outer and special clothing and shoes in the dressing room (closets);
• ensuring sanitary conditions (disinfectants, household equipment - buckets, brushes, vacuum cleaner, etc.).

In order to ensure the quality of the technological operations of the pharmaceutical warehouse and the goods stored there, access of unauthorized persons to the production premises intended for the reception, sorting, storage, packaging, dispensing and shipment of drugs is prohibited.

57. Concept, purpose and objectives of financial management. Composition and content of financial statements

Financial management, in other words, financial management is a system of principles, methods and forms of rational and effective regulation of financial resources and relations of an enterprise in order to ensure sustainable production and economic activity, achieve sufficient profits and increase the competitiveness of an economic entity.

Table 1. Known definitions of the term “financial management”

Financial management is aimed at increasing financial resources, investments and increasing the volume of capital. It can be represented by the following diagram:

Rice. 1. General scheme of financial management