Areas of activity of the pharmacy warehouse according to the charter. Coursework Pharmacy warehouse. Tasks. Functions. Warehouse Logistics. Temperature maintenance system during power outage

Introduction

Doctors and pharmacists have joint activities, which are determined by regional and regional programs to provide the population with free or preferential funds. Pharmacists keep records of patients attached to the pharmacy, and inform doctors in case of non-arrival of a patient on the list.

To provide 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 specific structure. Warehouses positioned in such a way as to ensure a functional relationship between all parts of the warehouse. pharmacy warehouse medicinal documentation

Tasks and functions of the pharmacy warehouse

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

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

1. concludes contracts with suppliers;
2.Purchases goods pharmacy assortment and medical products;
3. conducts claims and claims work, 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 State Fund;
6. ensures the safety, accepts orders from pharmacies, treatment-and-prophylactic and other institutions, as well as pharmaceutical enterprises for packaging, packaging and timely delivery of medicines and medical products on orders;
7. organizes strict observance of the order of accounting and dispensing of pharmaceutical, parapharmaceutical and other goods;
8.controls at all stages production activities;
9.Ensures control over the expiration dates and stay in the warehouse, the shipment of medicines and medical products, their timely sale, taking into account the expiration dates, as well as the observance of price discipline in the supply and settlements with suppliers and consumers;
10. complies with labor protection and safety requirements.

To perform the main functions, managers and staff of a pharmacy warehouse are required to follow the regulatory documents governing its activities, study supply and demand in the pharmaceutical market, observe the procedure for certification and quality control.

In the process of introducing standards for proper industrial practice manufacturers are faced with the need to control the quality of manufactured finished pharmaceutical products (FPP) at every stage of their delivery to the consumer. One of the most important steps in this process is quality assurance during the distribution and various stages of storage of finished medicinal products.

Various stages of storage are mentioned here due to the fact that in addition to intermediate storage of finished medicines in group packaging, the standards also establish rules for storage, distribution of FPP at any stage of storage, delivery or distribution of FPP in any type of packaging and packaging. The chain of delivery of finished medicinal products from the manufacturer begins immediately after the end of the production cycle of the medicinal product, and after the primary packaging of the finished dosage form (FP), in the case of transfer of the Angro packaging to the secondary packaging to another counterparty, or secondary packaging, including group packaging.

Due to the vastness of the areas of control over the distribution and storage of RTU drugs, there is a separate section of the cGxP standards called GDP (Good Distribution Practice) or Good Distribution Practice.

To analyze potential risks in the circulation of finished medicines, it is necessary to separate the complete cycle of the drug circulation chain from the manufacturer to the consumer into specific stages.

The main stages of the circulation of finished medicinal products after the completion of the production cycle can be roughly represented as follows:

Quarantine storage of RTU drugs at the manufacturer's warehouse
Storage finished products approved by the quality control department for shipment to consumers at the manufacturer's warehouse
Loading, delivery, unloading of RTU drugs on the way from the manufacturer's warehouse to the distributor's warehouse
Storage of RTU drugs at the distributor's warehouse
Loading, delivery, unloading of RTU drugs on the way from the distributor's warehouse to the warehouse for the final sale of RTU drugs
Storage of RTU drugs at the final sale warehouse.

This article will consider issues related to the storage of medicines in warehouse areas at various stages of the circulation of medicines on the way from manufacturer to consumer.

The ideal situation when handling a drug is to minimize logistics chain from the manufacturer to the consumer, but in addition to shortening the supply chain (regarding the time the drug is on the way, as well as the number of stages of unloading / distribution), one of the most important tasks when handling FPP is to control the conditions under which the drugs are stored and distributed. Typically, the main monitored parameters are temperature, humidity and the rate of change in temperature and humidity.

Despite the absence of special requirements for structural materials for the execution of enclosing structures, the requirements for thermal insulation of internal spaces from external environment are presented quite strict. As well as resistance to the growth of microorganisms in areas without sufficient lighting or air circulation. The peculiarities of the organization of the warehouse space suggest that the dimensions are much larger than the dimensions of the controlled production or auxiliary zones, but the requirements for the regulation of the temperature balance, the stability of maintaining the humidity level and air circulation in all points of the warehouse do not allow the use of an approach similar to the approach used for calculating ventilation systems. industrial premises.

Due to the traditional rack storage of finished products, it is necessary to take into account a significant proportion of aisles when organizing rack systems, at least the minimum required to move the lifting mechanisms.

To reduce the time spent on finished medicinal products in areas with uncontrolled temperatures (loading / unloading zone or the process of moving between stages of drug storage), warehouses, as a rule, are created close to the loading area, and the finished products are moved directly to vehicle... And the finished product release zones are placed as close as possible to the quarantine storage warehouse and further to the finished product warehouse.

Having considered the difficulties and difficulties arising in the organization of storage areas at a manufacturing enterprise, it can be noted that the creation of a warehouse that meets the many requirements of standards, norms and rules for ensuring the quality of medicines is not a trivial task, but temperature and humidity mapping storage areas are often even more complex than production facilities.

But modern development design techniques, engineering systems, monitoring systems, temperature and humidity control, ventilation system automation systems, as well as automation systems responsible for controlling the storage and circulation of batches of finished medicines on pallet storage, allows you to create a warehouse area that meets the most stringent requirements of standards, including including, and entered into force on March 1, 2017, the order of the Ministry of Health of Russia No. 646n dated August 31, 2016 on the organization of storage and circulation of finished medicines.

Below will be listed certain techniques to simplify the observance and maintenance of temperature and humidity parameters in a narrow range when creating a modern warehouse site.

Walling

As mentioned earlier, there are no special requirements for the surface of the enclosing structures, but, nevertheless, in order to eliminate the risks caused by damage or unsatisfactory condition of the surface, as well as instability of temperature and humidity conditions, it seems most reasonable to use surfaces similar to surfaces for a controlled unclassified zone. (CNC). Also, to ensure the preservation of temperature conditions when the power supply is cut off, it is recommended to use materials with high thermal insulation properties, and in especially critical cases, use a multilayer technology with air spaces. Regarding the roof, the situation is similar, but in addition to all other conditions, the issue of maintaining the integrity of the roof in a local climate should be considered separately, and decisions on the design implementation of the roof should be made taking into account the maximum risk limitation for medicines.

Rack storage organization

At present, in the absence of real alternatives to rack storage, the main task to reduce the risks of maintaining the temperature and humidity regime is to reduce the area under the aisles and maximize efficient use volumes. Both of these measures can be implemented with maximum automation of the movement of pallets through warehouse areas, but this implies significant capital investments, therefore the question of payback and the feasibility of using traditional methods of moving pallets or alternative methods should be assessed, analyzed and accepted from the point of view of full compliance with the security requirements. quality and in terms of economic feasibility... At the same time, one should not forget about the risk assessment of the adverse effect of the choice of one or another storage or transportation method on the properties of the RTU drug and maintaining the stability of the quality parameters.

Separately, it is worth considering the issue of materials used for rack storage. A certain time ago, the question of the admissibility or inadmissibility of using wooden pallets for storing and moving packaged medicines was quite acute. For solutions this issue it is proposed to use a similar approach to deciding on the choice of pallet material. The balance of risks and economic feasibility, as well as the involvement of carriers, since the issue of pallet turnover can be removed with their help, and is painless enough for the manufacturer's budget.

The issue of pallet washing is not considered separately, because it is quite simple to implement and should be provided at the design stage in the absence of the possibility of transshipment of drugs in the gateways between the production and storage areas, as well as when using the same pallets throughout the enterprise.

Ventilation system

The warehouse ventilation system should preferably be separated from the general ventilation of the enterprise for a number of reasons. The first reason is that the space-planning solutions used in warehouse storage are significantly different from solutions used in production areas. On the one hand, the volume of circulating air is quite significant, on the other hand, the rate of air exchange can be reduced due to the fact that storage areas are usually not classified according to cleanliness classes. An additional requirement for air exchange systems is that the reliability and stability of the parameters maintained is more critical than the speed of response and temperature correction. Also when organizing ventilation systems Special attention it is necessary to present air circulation throughout the entire volume of the warehouse due to the fact that the warehouse, as a rule, does not have lighting in standby mode, and, therefore, sufficiently favorable conditions for the development of mold and other microorganisms. This problem can be solved by introducing a denser duct network with a smaller cross-section instead of using a centralized air supply and centralized exhaust.

Cooling system

These systems are most critical in enterprises, whose warehouses must ensure the maintenance of a stable low temperature in the specified parameters (for example, insulin production). Nevertheless, the problem of stability, reliability and uniformity of cooling of the volume of warehouses is extremely important, as it is assessed in the framework of mapping and validation of warehouses with a lower temperature. The solution of this problem requires investments, but in the process of operation it will reduce the intensity of regular revalidation, and will also allow the use of simpler solutions in the monitoring system.

Temperature maintenance system during power outage

The issue of maintaining the specified conditions in emergency is extremely important in the design and construction of warehouse space, as it directly affects the stability and compliance with the parameters required for warehouses under the GDP. It should also be noted that, as part of the initial validation of a functioning warehouse, a test should be carried out to maintain the specified parameters in the event of an emergency power failure, a period of guaranteed preservation of conditions should be set, and a period after which it is necessary to check the product and revalidate the warehouse should be specified. Also, a separate ventilation system for the warehouse will allow the use of uninterruptible power supplies only to supply the most critical systems in an emergency. Instead of keeping all systems at a reduced power level, with the risk of disruption to each ventilation system.

Monitoring system

A variety of monitoring system options allow the manufacturer (distributor) to choose the most suitable one in terms of operation, capital investment and risk analysis. The only thing worth noting is that when applying automated systems monitoring and control climatic conditions the warehouse must strictly adhere to the standards and requirements of GAMP 5 and CFR Part 11, otherwise there is a risk of wasted investments in an expensive monitoring system that cannot pass validation, while traditional system with manual recording of parameters at several points can be validated with a clear structure of standard procedures, instructions and work organization at significantly lower capital and operating costs. But, again, with significant warehouse space and as an increase in attractiveness for customers (in the case of distributors), equipping warehouse space with a fully automatic and successfully validated monitoring and control system can be justified from both economic and operational points of view.

Fire protection systems

Taking into account realities and requirements Russian legislation, the requirements for the complex of fire-prevention measures and systems with which warehouse areas are equipped constitute a fairly extensive area. It should only be noted that fire-fighting systems (fire extinguishing, warning and evacuation systems) should be assessed in terms of risks both for the product and for personnel, but at the same time, with a negligent approach to design and approval in the Ministry of Emergency Situations, it should be understood that the lack of these approvals will serve as an obstacle to the start of operation of both the warehouse and full production (in the case of combined production and storage areas). But in this section, there are nuances that allow the use of alternative approaches and solutions. An example is fully automatic system moving pallets in the warehouse, and restricting the access of personnel directly to the area of rack storage. In this case, it is possible to use systems for lowering the oxygen level in the air of the warehouse, and thus reducing the fire extinguishing pipelines, as well as the volume of fire-fighting measures. But, once again, I repeat that the primary task in the design and creation of a warehouse from the point of view of fire-prevention measures is the coordination of fire-prevention systems in the supervisory authorities.

According to the requirements of cGMP and GDP (Good Documentation Practice) and the qualification of processes must be foreseen in advance, retrospective validation is not allowed, therefore, the validation plan for both a warehouse separately and as part of a pharmaceutical production must be foreseen in advance at the design stage and agreed with the service. quality assurance of the manufacturer. The main task is to fully comply with all the requirements of good practices for the invariability of product quality at the stages of storage and handling, as well as the ability to control and monitor product quality, personnel safety. Be that as it may, the plan of validation measures for putting the warehouse into operation must be approved in advance, coordinated with the quality assurance service, indicating the deadlines, dates for repeated validation activities and possible risks... Ideally, the requirements for the warehouse, climatic parameters, the order of use. The movement, workflow and all related processes must be contained in the User Requirements Specification (URS), and all requirements, without exception, must pass all stages of qualification and be contained in all documents that regulate, control and standardize procedures related to the use of storage facilities.

Staff

Requirements for personnel associated with any processes in a pharmaceutical warehouse (both the movement of finished medicines, control of auxiliary processes, and document flow) do not differ from the requirements for personnel in pharmaceutical production, in addition, that the warehouse should have a responsible person responsible (by analogy with an authorized person) for the quality of each batch of products passing through the warehouse.

Documentation

The requirements for documentation regulating the activities of warehouses are absolutely identical to the requirements of Good Documentation Practice for any other pharmaceutical industry and must include full traceability, change control, control of non-conformities and other aspects. It should be noted that the implementation of a sufficient system of proper workflow is one of the most important aspects that allow the warehouse to be validated and qualified before commissioning, and monitoring the status of the workflow system should not be overlooked when creating a warehouse.

In conclusion, it can be noted that a separate pharmaceutical warehouse complex within the drug circulation chain or as part of a pharmaceutical production, in terms of quality assurance and operational requirements, cannot and should not differ from pharmaceutical production. Some aspects of the warehouse operation are even more strictly controlled than during production, and losses during improper performance quality assurance requirements can be extremely painful for a manufacturer / distributor both in terms of batch loss and reputation, and we are not even talking about fines from regulatory authorities, but about the safety of consumers and personnel. Therefore, despite the outward simplicity of the organization of the warehouse complex, it is necessary not to reduce the requirements for design and creation, but to try to analyze the maximum number of possible risks at the initial or intermediate stages in the process of release and circulation of drugs on the market.

LECTURE PLAN

1.	Pharmacy warehouse, its tasks and functions
2.	Requirements for the placement of a pharmacy warehouse, warehouse structure
3.	Equipment and furnishing of a pharmacy warehouse
4.	Movement of goods in a pharmacy warehouse:
	4.1.	Acceptance of goods
	4.2.	Quality checking
	4.3.	Placement of goods at storage locations (video)
	4.4.	Release of goods from the storage department.

1 ... To fulfill the main tasks facing the wholesale link of commodity circulation, warehouses are created that function independently as entity, or are structural units distributor.

Warehouses- this is a building, structures and various devices intended for the reception, placement and storage of goods received on them, preparing them for consumption and delivery to the consumer.

^ Pharmacy warehouse organized for the purpose of supplying medicines, medical products and other goods to pharmacies, health care facilities and other organizations and enterprises.

The main tasks of a pharmacy warehouse are: acceptance, storage and delivery to pharmacy organizations, as well as pharmaceutical manufacturing enterprises Medicines, medical devices, pharmaceutical equipment and inventory that meet all quality requirements under current legislation.

Pharmacy warehouse functions:

concludes contracts with suppliers;
carries out the purchase of goods of the pharmacy assortment and medical devices;
conducts claims and claims work, imposes penalties on suppliers in case of violation of contractual obligations;
accepts drugs and medical devices from suppliers in terms of quality, quantity and cost;
organizes the storage of drugs and medical devices, taking into account their physical and chemical properties and the requirements of the State Pharmacopoeia;
ensures the safety and accepts orders from pharmacies, health care facilities and other institutions, as well as pharmaceutical companies for packaging, packaging and timely delivery of drugs and medical products;
organizes strict adherence to the procedure for accounting and dispensing pharmaceutical, parapharmaceutical and other goods;
complies with labor protection and safety requirements.

To perform the main functions, the managers of the pharmacy staff

Warehouses are obliged to follow the regulatory documents governing its activities, study supply and demand in the pharmaceutical market, comply with the certification and control procedure, and draw up the appropriate documentation.

^ 2. Pharmacy warehouse can be located in a detached non-residential building, industrial building or in non-residential premises of residential buildings. The warehouse should be isolated from other premises, have a separate entrance, driveway, ramp for unloading goods.

When a warehouse is located in a building for medical or pharmacy purposes, administrative and amenity premises can be shared. If the 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 apartments.

Warehouses must have power supply, heating, water supply, sewerage systems, supply and exhaust ventilation. The decoration of the premises (the inner surface of walls, ceilings) must be smooth, allowing for the possibility of wet cleaning with the use of disinfectants.

The ability of unauthorized persons to access industrial premises should be excluded.

The pharmacy warehouse includes the following production facilities and zones:

1.reception (reception department)- qualitative and quantitative acceptance of goods received from suppliers;

2.storage department- storage of goods, sets of orders for pharmacies and health care facilities;

3.expedition department- packaging of goods and delivery to pharmacies and health care facilities;

4.procurement department- work with suppliers, buyers, conclusion of contracts and control over their execution;

5.Accounting- accounting, documenting business operations of the pharmacy warehouse.

^ In the reception department it is necessary to provide zones:

Unloading, unpacking and sorting of the arrived goods;

Temporary storage of domestically produced medicines;

Temporary storage of imported goods;

Movement and placement of mechanization and transportation means;

Checks of medicines (solutions, including for injections) for the absence of mechanical impurities;

Temporary storage of goods for which a complaint is presented.

The reception department should be isolated from other premises, but have an interconnection with the premises for the main storage of medicines.

In storage rooms, drugs can be placed: on racks, on standard pallets in factory containers, on sub-items, in containers of elevator racks (small goods).

The number of storage rooms depends on the groups of medicines requiring isolated placement.

Traditionally, regardless of the volume of the warehouse, the following storage departments are provided for: dry medicines, liquid medicines, finished medicines, sanitation and hygiene goods, dressings, poisonous and narcotic drugs (if there is a license to store them).

The following main zones must be envisaged in the expedition:

To accommodate goods prepared for shipment;

For the movement of means of mechanization (transport);

For storage of intra-warehouse vehicles.

^ 3. Equipment and equipment of the warehouse

The pharmacy warehouse should be equipped with equipment and inventory in accordance with the functions performed. The equipment and furnishings of a commodity pharmacy warehouse must correspond to the main tasks that are solved in the warehouse, be up-to-date.

pharmacy warehouse:

work tables and chairs;
when carrying out the repackaging function, it is additionally necessary:

Distillers;

Drying cabinets;

An indispensable condition for opening a warehouse is the availability of specialists with vocational education- pharmacists and pharmacists.

Production activities (purchase, acceptance, storage, wholesale of drugs and medical devices, etc.) are carried out by specialists with a pharmaceutical education.

^ 4. Movement of goods in the warehouse consists of the following operations: unloading, acceptance for storage, quality control, placement at storage locations, goods release from storage departments.

^ 4.1. Acceptance of goods ... Acceptance of goods, incl. Medicines, carried out by the warehouse reception department in accordance with the regulatory documentation.

To receive and transfer received products to the appropriate departments, each pharmacy warehouse creates selection committee consisting of at least three people. The chairman of the selection committee is the head of the reception department, and in warehouses with a small amount of work - the head of the pharmacy warehouse.

The persons carrying out the acceptance are obliged to know well the rules for the acceptance of products in terms of quantity, quality and cost, the basic and special conditions for the delivery of medical products, the physical properties of drugs, the forms of their release and other important issues.

All deliveries must be accompanied by documents allowing to establish: the date of shipment, the name of the drug (including the dosage form and dosage), the quantity delivered, the price of the dispensed drug or the cost of the drug, the name and address of the supplier and recipient.

Unpacking of all products in the receiving department should be carried out in the presence of the heads (deputies) of those departments to which the goods will be transferred.

The delivery of goods is carried out in accordance with the contract. One or several consignments of goods can be received under the contract.

The consignment(at wholesalers, warehouses and retail) - products of one name, received under one transport document, invoice or invoice.

Before starting acceptance, you must pay attention to the expiration date of the medicinal product.

^ Shelf life- the period of time during which the quality of the finished drug is guaranteed to meet the requirements of regulatory documents.

Depending on the shelf life limits, products are divided into perishable (from 6 hours to 96 hours), short-term storage (from 12 hours to 30 days); long-term storage: with a limited shelf life (in practice pharmaceutical organizations a limited shelf life of up to 2 years is considered); without limitation of the expiration date (can save consumer properties for several years without losing them).

Special delivery conditions define the remaining expiration dates, according to which drugs must be shipped by the manufacturer so that at the time of shipment at least 80% of the expiration date indicated on the label remains, and for bacterial drugs, dental and polymer materials- not less than 5% of the shelf life.

When shipping the specified products from a warehouse in retail network and for healthcare facilities, the remaining shelf life must be at least 6%, and for bacterial preparations, at least 40% of the shelf life indicated on the label.

Medical products with a shelf life of more than two years can be shipped to the buyer if the remaining shelf life is at least 18 months. Delivery of products with a shorter shelf life can be made by agreement with the buyer, which is determined by the contractual terms.

The remaining shelf life can be determined by the batch number.

^ Series- a certain amount of a homogeneous finished product manufactured in one derivative cycle under constant conditions.

Series number Is a numeric, alphabetic or alphanumeric designation that specifically identifies a series.

The following options for specifying the expiration date are acceptable: "Best before X 04" or "before X 04".

^ An example of decoding a series of medicinal products :

ASKORUTIN - 96052007 - manufactured in May 2007, 96 - production number of the series;

Valid until VI 2009 - valid until June 2009.

After checking the accompanying documents and the remaining expiration dates, the consignment is accepted in terms of quantity and quality.

^ Reception by quantity ... Upon acceptance of packaged domestic and imported goods in terms of quantity, it is necessary to take into account that their quantitative characteristics include the mass of the product itself (net) and packaging (tare). Incoming goods may or may not be packed. If the goods are packed (boxes, boxes, etc.), then its acceptance begins with the determination of the gross weight.

^ Gross weight(M b) - the total weight of the goods and packaging.

Gross weight can be determined in several ways:

Direct outweighing of all packaging units included in the consignment;

By calculation (multiplying the average gross weight of each packaging unit by their total number) if all packaging units of the batch have a fixed (equal) weight.

^ Net weight(M n) - the mass of the goods without packaging.

For unpackaged goods - by weighing;

For packaged goods - according to the formula M n = M b - M t, where M t is the mass of the package.

^ Quality reception ... Acceptance of products in terms of quality and completeness (the latter is provided for some medical devices) is carried out after acceptance of products in terms of the number of places and gross weight.

^ 4.2. Quality checking ... The quality control procedure for drugs circulating on the pharmaceutical market is regulated by the relevant orders of the Ministry of Health of Russia,

All drugs supplied to pharmacies and medical institutions from pharmacy bases (warehouses) different forms property and departmental subordination are subject to control.

Medicinal products that have duly issued certificates of conformity, issued upon admission to the place of destination, are subject to selective control for certain indicators: description, packaging, labeling.

^ Drug control indicators

Index	Control content
Description	Examination appearance, color, smell
Package	Checking the integrity of the packaging and its compliance with the physicochemical properties of drugs
Marking	Compliance with the labeling of primary, secondary and group packaging, the presence of an insert leaflet in Russian in the package (or separately in a pack for the entire quantity of drugs); correct design packaging of poisonous and narcotic drugs. Medicines intended for the manufacture of solutions for injection must have an indication "Suitable for injection."

In addition, drugs for injections and eye drops are subject to mandatory serial control for compliance with the requirements of regulatory documents for pH and mechanical inclusions.

Medicinal plant raw materials (MP) (each batch) are checked according to indicators: authenticity, crushing, content of impurities, degree of infestation by barn pests. Briquettes are additionally tested for strength and disintegration. In addition, each batch of medicinal plant raw materials is checked for the absence of radioactivity.

In cases requiring quality control of drugs, the number of checked packaging units in a batch of goods is determined in accordance with the established procedure and the required sample is taken.

The selected samples are transferred to the laboratory located in the warehouse, or to the laboratory with which an agreement has been concluded. The transfer of goods to the main storage is carried out after receiving laboratory tests or an expert opinion.

^ 4.3. Placement of goods at storage locations (video)

4.4. Issuance of goods from the storage department... The delivery of goods to pharmacy organizations, healthcare facilities and other purchasing organizations is carried out on the basis of orders issued in accordance with contracts, in writing, by phone, fax or using other means of communication.

The persons responsible for the delivery of drugs provide each order of drugs with accompanying documents and control the availability of all the necessary information in the shipping documents. Such documents can be consignment notes, invoices, etc.

For order picking, work tables or roller conveyors with installations controlled by pickers are equipped in the picking area. Small batches of drugs should be placed in the packaging container, standing on the tables or on the conveyor. The filled boxes with medicines are placed on the conveyor behind the container.

At the end of the tables or conveyor there is an inspector who checks the correctness of the order picking according to the printout of the order received.

Containers with orders are delivered to the expedition.

When packing goods on an expedition, the packer fills the box and signs two copies of the box insert, puts one copy of the insert in the box, and the second is attached to the waybill, which remains on the expedition.

From the expedition, after checking the intactness of the seal and accompanying documents, the container with the order goes to the ramp in the box or area where the car is fitted for shipment to the customer.

The movement of goods through the warehouse is carried out in strict accordance with the current documentation for the accounting of goods and control in all departments of the warehouse. In storage departments, quantitative accounting should be made for each nomenclature and accounting position. Based on duly executed accounting documents the materially responsible person of the warehouse is obliged to note the receipt and consumption of goods.

Appendix No. 1

Indicative list of required equipment

pharmacy warehouse:

racks, pallets, items;
cold rooms for storing thermolabile substances;
mechanization equipment for loading and unloading operations;
devices for recording air parameters;
lockable metal cabinets (safes) for storing certain groups of drugs, accounting documents and reference literature;
work tables and chairs;
cabinets for separate storage of special and outer clothing and footwear;
disinfectants and equipment to ensure the sanitary regime;
when carrying out the repackaging function, the following are additionally required:

- weighing devices checked in accordance with the established procedure;

Distillers;

Drying cabinets;

Other equipment as required.

Appendix No. 2

SLIDES

(multimedia presentation)

Appendix No. 3

VIDEO

"Storage of drugs and medical devices in a pharmacy warehouse"

^ UPDATING THEME

Currently, the pharmaceutical market in Russia is developing quite dynamically.

Let's recall from previous topics:

What are the channels through which the goods move from the producer to the consumer?

Who represents the wholesale link of commodity circulation?

As we can see, in the process of movement of goods from the manufacturer of pharmaceutical goods to the consumer, most of the time (approximately 80-90%) falls on the storage process. Therefore, the organization of warehouses occupies an important place in the system of goods movement.

Consequently, a modern pharmacist must know the basic requirements for organizing pharmacy warehouses, know the regulatory and technical documentation governing their activities, know the rules for storing medicines, medical devices, parapharmaceutical products.

Pharmacy warehouse design - laborious process which can be performed after identifying a clear need for drugs and medication. Before we reveal all the nuances of designing a pharmacy warehouse, let's define what a pharmacy warehouse is and what functions it performs.

A pharmacy warehouse is an organization that aims to provide citizens with pharmaceuticals. A pharmacy warehouse has its own infrastructure and can be:

Urban
District
The regional
The federal

The owner of a pharmacy warehouse can be the state or a private person (company). The form of ownership of the pharmacy warehouse was approved by the Government Decree on September 1, 2002. The main organizational and legal materials are reflected in the Civil Code of the Russian Federation,

In our company, the design of a pharmacy warehouse is carried out on commercial basis... The customer or investor pays for the project, according to the terms of the General Contract agreement, which stipulates the methods and terms of payment.

The main tasks of the pharmacy warehouse: reception, storage and delivery to pharmacy organizations, medical institutions and other organizations, as well as pharmaceutical manufacturing enterprises of drugs, medical devices, pharmaceutical equipment, medicines, pharmaceuticals and inventory that meet all quality requirements under current legislation. To organize the work of a pharmacy warehouse, you will need a business plan, which will outline the functions of employees, regulations regulating their activities, the supply and demand in the regional pharmaceutical market was studied, the procedure for certification and quality control of goods was taken into account, and the conditions for issuing the necessary documentation were determined. Without a business plan, designing a pharmacy warehouse will be much more difficult.

Pharmacy warehouse design begins with a study terms of reference(TOR) of the customer, which should take into account:

Pharmacy warehouse working hours
Area, dimensions, dimensions of the pre-fabricated building
Pharmacy warehouse construction site
The main purpose of the internal premises (administrative, industrial, household, etc.)
The volume of stored goods in the warehouse
Areas of acceptance and sale of pharmaceutical products
Storage conditions of goods (normal and special)
Expedition mode and working conditions

The project owner will need a forecast of the demand for the products of this pharmacy warehouse, as well as the estimated breadth of the assortment and the volume of products sold. After careful processing and analysis of all the data received, the design of the pharmacy warehouse will be organized. Immediately, we note that the area of internal premises will depend on the total size of the warehouse, working hours and the number of employees. The design of a pharmacy warehouse is carried out in accordance with the current sanitary norms and rules (SNiP). The layout of the wholesale pharmacy warehouse includes common administrative and utility rooms. The retail and wholesale-retail pharmacy warehouses have separate internal premises. Warehouse space in both wholesale and retail warehouse must be necessarily separated from administrative and amenity and other premises, have a separate entrance, driveway, ramp for unloading goods. Wholesale pharmacy warehouses can receive products for wholesale from manufacturers or others wholesale companies, institutions, organizations (foreign or domestic), various ministries.

Despite the fact that the pharmacy warehouse is mainly engaged in the procurement and sale of pharmaceutical products, the design of a pharmacy warehouse refers to production type design, which we wrote about in the heading "Special offers". We offer turnkey design of a pharmacy warehouse, which includes:

Architectural project
Constructive project
Engineering project

In the project of the pharmacy warehouse, great attention is paid to engineering systems and communications. Without high-quality lighting, heating, ventilation, water supply and sewerage systems, the prefabricated warehouse will not be allowed to operate. If you are in the mood for a quick payback of the project, its profitability and profitability, please contact our specialists. Turnkey design of a pharmacy warehouse will allow you to save time and money, as well as equip the pharmacy warehouse with high-tech equipment and well-thought-out warehouse logistics. We are waiting for orders!

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State educational institution of higher professional education Nizhny Novgorod State Medical Academy of the Federal Agency for Healthcare and Social Development

Department of UEF and Pharmaceutical Technology

Pharmacy warehouse. Tasks. Functions. Warehouse Logistics.

Course work

5th year students of the Faculty of Pharmacy,

Head: S. V. Kononova

N. Novgorod, 2009

Introduction ………………………………………………………………………… 3

Theoretical part.

Normative legal documentation ……………………………………… .4

Tasks and functions of the pharmacy warehouse ……………… ……………………… ..5

Organization of the pharmacy warehouse …………………………………… ..6

Warehouse premises ……………………………………………………… .. .7

Equipment and inventory of pharmacy warehouses …………………………… .10

Checks of pharmacy warehouses …………………………………………… ..11

Storage of drugs and other groups of goods …………………………………… .. 11

Movement of goods in the pharmacy warehouse …………………………………… ..19

Automation of commodity circulation management in a pharmacy warehouse ... ... .22

Operational accounting at the pharmacy warehouse …………………………………… 25

Warehouse logistics …………………………………………………… ..28

The practical part.

Pharmacy warehouse - warehouse of the group of companies "Apteka holding" ………… .33

Distributor companies ………………… ……………………………… 36

Algorithm of goods acceptance ……………………………………………… ... 39

Conclusions ……………………………………………………………………… 48

Conclusion ………………………………………………… ……………… ..49

Used Books…………………………………………………. .50

Introduction.

An important part of health care is the pharmaceutical service, which is designed to provide the population with timely and high-quality medical care. The task of the pharmaceutical service is to better meet the needs of the population and healthcare facilities in medicines, develop a network pharmacies, raising the level of training and improving the pharmaceutical staff.

The general availability of medical care is ensured by the development of a network of pharmacies and pharmacy points to bring them as close as possible to the population.

Joint activities of doctors and pharmacists to determine the need for medicines and allocate their resources, systematically informing doctors about the availability of medicines and the prospects for supplying them improves the provision of medicines to the population.

To provide pharmacies with drugs, 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 specific structure. Warehouses are located in such a way as to ensure a functional relationship between all parts of the warehouse.

Regulatory and legal documentation.

The procedure for the implementation of pharmaceutical activities at wholesale medicines on the territory of the Russian Federation is established by the Industry Standard “Rules wholesale trade medicines. Basic Provisions ”, entered into force on September 1, 2002 and may have any form of ownership and any organizational and legal status provided for by the Civil Code of the Russian Federation.
According to this standard, wholesale trade in drugs is carried out only if there is a license issued in accordance with the established procedure. Information about the license number, validity period of the license and the issuing authority is placed in convenient places for review. An enterprise wholesale trade of medicines must have a sign on which information is placed on the organizational and legal form of the enterprise, its corporate name, location (legal address) and operating hours. The premises of the wholesale enterprise should include warehouse (pharmacy warehouse) and administrative premises. The area of storage facilities for the main production purpose must correspond to the volume of stored goods per unit of storage area, including areas for product acceptance, main storage of drugs, premises for drugs requiring special conditions storage (thermolabile, narcotic and psychotropic, poisonous and potent, etc.), expeditionary. When designing pharmacy warehouses, the accuracy in calculating the storage space largely depends on the correct forecast of the demand for the products of this warehouse and the determination of the required stocks (expressed in physical terms). When designing storage facilities, it is necessary to take into account the breadth of the assortment and the volume of products sold, as well as the requirements for the conditions and shelf life of products. The total area of administrative and utility rooms depends on the number of personnel and is calculated in accordance with the current sanitary norms and rules (SNiP). If the warehouse of a drug wholesaler is located in a building for medical or pharmacy purposes, the administrative premises may be shared.

Tasks and functions of the pharmacy warehouse.

Pharmacy warehouse is organized with the aim of supply of medicines, medical devices and other goods to pharmacy organizations of medical and preventive institutions and other organizations and enterprises.
The main tasks of the pharmacy warehouse is the reception, storage and distribution of pharmacy organizations, medical institutions and other organizations, as well as pharmaceutical manufacturing enterprises of drugs, medical devices, pharmaceutical equipment and inventory that meet all quality requirements under current legislation.
In accordance with the main tasks, the pharmacy warehouse performs the following function:

concludes contracts with suppliers;
carries out the purchase of goods of the pharmacy assortment and medical devices;
conducts claims and claims work, imposes penalties on suppliers in case of violation of contractual obligations;
accepts drugs and medical devices from suppliers in terms of quality, quantity and cost;
organizes the storage of drugs and medical devices, taking into account their physical and chemical properties and the requirements of the State Pharmacopoeia;
ensures safety, accepts orders from pharmacies, medical and prophylactic and other institutions, as well as pharmaceutical enterprises for packaging, packaging and timely delivery of drugs and medical devices on orders;
organizes strict adherence to the procedure for accounting and dispensing pharmaceutical, parapharmaceutical and other goods;
carries out control at all stages of production activities;
ensures control over the expiration dates and stay in the warehouse, the shipment of drugs and medical devices, their timely implementation, taking into account the expiration dates, as well as the observance of price discipline in the supply and settlements with suppliers and consumers;
complies with labor protection and safety requirements.

To perform the main functions, the managers and staff of the pharmacy warehouse are required to follow the regulatory documents governing its activities, study the supply and demand in the pharmaceutical market, observe the procedure for certification and quality control, and draw up the relevant documentation.

Organization of the pharmacy warehouse.

A modern pharmacy warehouse is a complex technical structure that has a specific structure. Warehouses are located in such a way as to ensure a functional relationship between the areas of loading and unloading, acceptance, storage, picking and release of orders. When carrying out loading and unloading operations, the incoming goods must be protected from atmospheric precipitation, exposure to low and high temperatures.
Wholesale enterprises may receive products for wholesale from manufacturers or others wholesale organizations which may belong to different ministries, be foreign or domestic. They can also sell (transfer at the disposal) drugs to other wholesalers, manufacturing enterprises for production purposes, pharmacy organizations and institutions, research institutes, individual entrepreneurs licensed for medical activities. The assortment of drug wholesalers may include pharmaceutical products - drugs (including homeopathic drugs) and medical devices, parapharmaceutical products (hygiene and cosmetic products, biological food additives, etc.), as well as other goods circulating on the pharmaceutical market (medical instruments, substances, etc.). Medicines sold on the territory of the Russian Federation must be registered in accordance with the established procedure. It is prohibited to sell drugs that have become unusable, expired and rejected during the certification process.

Warehouse premises.

The warehouse can be located in a separate non-residential building, an industrial building or in non-residential premises of residential buildings. The warehouse should be isolated from other premises, have a separate entrance, driveway, ramp for unloading goods. When a warehouse is located in a building for medical or pharmacy purposes, administrative and amenity premises can be shared. If the 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 apartments.
Warehouses must have power supply, heating, water supply, sewerage systems, supply and exhaust ventilation. The decoration of the premises (the inner surface of walls, ceilings) must be smooth, allow for the possibility of wet cleaning with the use of disinfectants, while the use of unpainted wooden surfaces is not allowed; finishing materials of the premises must comply with the established requirements. Additional requirements are imposed on the floor coverings in terms of resistance to the effects of mechanization, wet cleaning with the use of disinfectants, and the absence of dust-forming action. At the warehouse, it is necessary to allocate a special isolated place for storing detergents and disinfectants, inventory and materials used for cleaning premises, processing equipment, and a dressing room. In the dressing room, outerwear and shoes are stored separately from removable special clothes and shoes.

When carrying out loading and unloading operations, the incoming goods must be protected from atmospheric precipitation, exposure to low and high temperatures.

Acceptance area pharmaceutical products can occupy a separate warehouse or represent a separate area of the storage area. Its main functions are acceptance of goods in terms of quantity, completeness and quality; completeness and quality; verification of accompanying documentation; conducting claims work; distribution of goods by storage locations in accordance with the methods and conditions of storage of individual groups of goods used in the warehouse. In addition, the acceptance site can be assigned the functions of sampling goods for quality analysis; packing of goods, picking of enlarged units for storage in a warehouse, as well as dismantling of the latter for the same purpose; temporary storage (accumulation) of incoming cargo for operational distribution in the main warehouse areas.

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

Medicines requiring special storage conditions must be immediately identified and stored in the prescribed manner.

Premises for storing narcotic drugs, psychotropic substances, poisonous and potent substances must comply with the established requirements (see Order No. 330 of 12.11.1997).
The possibility of unauthorized persons' access to production facilities (part of the warehouse intended for receiving, sorting, storing, assembling, dispensing and shipping drugs) should be excluded.

Storage area allows you to implement the functions of a pharmacy warehouse related to ensuring the safety of goods (compliance with storage conditions, control over expiration dates, the 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 utilization rate of the warehouse area (an indicator characterizing the ratio of the area occupied by the cargo directly to the total area of the cargo area) and the utilization rate of the warehouse volume (an indicator characterizing the ratio of the volume occupied by the cargo to the cargo volume of the storage area). Depending on the chosen storage method and the use of one or another equipment, it is possible to achieve optimal use of the cargo storage area, taking into account their further processing. As a rule, in the storage areas of the pharmacy warehouse, orders are also collected and transferred to the forwarding department.

Description

An important part of health care is the pharmaceutical service, which is designed to provide the population with timely and high-quality medical care. The task of the pharmaceutical service is to more fully meet the needs of the population and medical institutions in medicines, develop a network of pharmacies, improve the level of training and improve pharmaceutical personnel.

Theoretical part.

Normative legal documentation ……………………………………… .4

Tasks and functions of the pharmacy warehouse ……………………………………… ..5

Organization of the pharmacy warehouse …………………………………… ..6

Warehouse premises ……………………………………………………… ... 7

Equipment and inventory of pharmacy warehouses …………………………… .10

Checks of pharmacy warehouses …………………………………………… ..11

Storage of drugs and other groups of goods …………………………………… ..11

Movement of goods in the pharmacy warehouse …………………………………… ..19

Automation of commodity circulation management in a pharmacy warehouse ... ... .22

Operational accounting at the pharmacy warehouse …………………………………… 25

Warehouse logistics …………………………………………………… ..28

The practical part.

Pharmacy warehouse - warehouse of the group of companies "Apteka holding" ………… .33

Distributor companies ……………………………………………… 36

Algorithm of goods acceptance …………………………………………… ... 39

Conclusions ……………………………………………………………………… 48

Conclusion ……………………………………………………………… ..49

Used Books…………………………………………………..

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