Directions of the pharmacy warehouse according to the charter. Term paper Pharmacy warehouse. Tasks. Functions Warehouse Logistics. The system for maintaining temperature when the power supply is interrupted

Introduction

Doctors and pharmacists have a joint activity, which is 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 if the patient is not 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 certain structure. Warehouses positioned in such a way as to ensure a functional relationship between all parts of the warehouse. pharmacy warehouse drug documentation

Tasks and functions of the pharmacy warehouse

A pharmacy warehouse is a room specially designed for storing medicinal and medical facilities and drugs. In addition to storage, a pharmacy warehouse can also purchase and sell medical drugs and products, as well as medical devices, pharmacy equipment and inventory, which meet all quality requirements under applicable law.

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

1. concludes contracts with suppliers;
2. procure the goods of the pharmacy assortment and medical products;
3. conducts claims and claims work, imposes penalties to suppliers in case of violation of contractual obligations;
4. accepts medicines and medical devices from suppliers in terms of quality, quantity and cost;
5. organizes the storage of medicines and medical devices, taking into account their physico-chemical properties and the requirements of the Global Fund;
6. ensures safety, accepts orders from drugstores, medical and preventive and other institutions, as well as pharmaceutical enterprises for the packaging, acquisition and timely delivery of medicines and medical devices on orders;
7. organizes strict compliance with the accounting and dispensing of pharmaceutical, parapharmaceutical and other goods;
8. exercises control at all stages production activities;
9. provides control over the expiration dates and stockpiling, shipment of medicines and medical devices, their timely implementation taking into account the expiration dates, as well as compliance with price discipline in the supply and settlements with suppliers and consumers;
10. complies with labor protection and safety requirements.

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

In the process of implementing standards of good manufacturing practice, manufacturers are faced with the need to control the quality of manufactured finished medicines (SFS) at each stage of their delivery to the consumer. One of the most important stages of this process is quality assurance in the distribution and various stages of storage of finished drugs.

The various stages of storage are mentioned here because, in addition to the intermediate storage of finished drugs in group packaging, the standards also establish rules for the storage, distribution of drugs, at any stage of storage, delivery or distribution of drugs, in any type of packaging and packaging. The chain of delivery of finished drugs from the manufacturer originates immediately after the end production cycle medicinal product, and after the initial packaging of the finished dosage form (GLF), in the case of transferring the Angro packaging to the secondary packaging to another counterparty, or secondary packaging, including group packaging.

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

To analyze the potential risks in the circulation of finished drugs, it is necessary to separate the entire cycle of the drug supply chain from the manufacturer to the consumer at specific stages.

The main stages of the circulation of finished drugs after the completion of the production cycle can conditionally be represented as follows:

Quarantine storage of drugs in the manufacturer’s warehouse
Storage finished productsapproved by the quality control department for shipment to consumers at the manufacturer’s warehouse
Loading, delivery, unloading of OTC drugs on the way from the manufacturer’s warehouse to the distributor’s warehouse
Storage of drugs in the distributor’s warehouse
Loading, delivery, unloading of OTC drugs on the way from the distributor’s warehouse to the warehouse for the final sale of OTC drugs
Storage of drugs in the warehouse of final sale.

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

An ideal situation when handling a medicinal product is to minimize the supply chain from producer to consumer, but in addition to shortening the supply chain (regarding the time it takes for the drug to travel, as well as the number of stages of unloading / distribution), one of the most important tasks when handling FPPs is control of the conditions under which drugs are stored and distributed. As a rule, the main controlled parameters include temperature, humidity and the rate of change of 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 the external environment quite strict. As well as resistance to the growth of microorganisms in areas without adequate lighting or air circulation. The features of the organization of the storage space suggest that the dimensions are much larger than the dimensions of the controlled production or auxiliary zones, but the requirements for regulating the temperature balance, stability of maintaining the level of humidity and air circulation at all points of the warehouse do not allow using an approach similar to that used for calculating ventilation systems production facilities.

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

To reduce the time spent on the finished drugs in areas of uncontrolled temperature (loading / unloading zone or the process of moving between the stages of storage of HFs), warehouses are usually created close to the loading area and the finished product is transferred directly to the 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 reviewed the difficulties and difficulties arising from the organization of warehouse areas at a manufacturing enterprise, it can be noted that the creation of a warehouse that meets many of the requirements of standards, norms and rules for ensuring the quality of medicines is not a trivial task, but also temperature and humidity mapping warehouse areas often presents even greater complexity than production facilities.

But modern development design techniques, engineering systems, monitoring systems, temperature, humidity control, ventilation systems automation systems, as well as automation systems responsible for controlling the storage and handling of a series of finished medicines on pallet storage allows you to create a warehouse area that meets the most stringent requirements of standards, including date, and the order of the Ministry of Health of Russia No. 646n dated 08/31/2016 on the organization of storage and circulation of finished medicines that entered into force on March 1, 2017.

Certain techniques will be listed below to simplify the observance and maintenance of temperature and humidity parameters in a narrow range when creating a modern storage area.

Walling

As mentioned earlier, there are no special requirements for the surface of enclosing structures, but, nevertheless, to exclude risks caused by damage or poor condition of the surface, as well as instability of the temperature and humidity conditions, it seems most reasonable to use surfaces similar to those for a controlled unclassified zone (CNC). It is also recommended to use materials with high thermal insulation properties, and in especially critical cases, to use multilayer technology with air gaps to ensure the preservation of temperature conditions when power is turned off. Regarding the roof, the situation is similar, but in addition to all other conditions, the issue of preserving 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 limit for medicines.

Organization of shelf storage

Currently, in the absence of real alternatives to rack storage, the main task to reduce the risks of maintaining the temperature and humidity conditions is to reduce the area under the aisles and maximize efficient use volumes. Both of these measures can be implemented with the maximum automation of moving pallets in storage areas, but this involves significant capital investments, so the issue of payback and the feasibility of using traditional ways of moving pallets or alternative methods should be evaluated, analyzed and adopted from the point of view of how full compliance with security requirements quality and in terms of economic feasibility. We should not forget about the risk assessment of the adverse effect of the choice of a particular storage or transfer method on the properties of the medicinal product and maintaining the stability of the quality parameters.

Separately, it is worth considering the issue of materials used for shelf storage. A certain time ago, the question of the admissibility or inadmissibility of using wooden pallets for the storage and movement of packaged medicines was rather 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 budget of the manufacturer.

The question of washing pallets is not considered separately, because it is quite easy to implement and should be provided at the design stage if there is no possibility of overloading drugs in the locks 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 stock storagesignificantly differ from the solutions used in the production facilities. On the one hand, the volume of circulating air is quite significant, on the other hand, the intensity of air exchange can be reduced due to the fact that storage areas, as a rule, are not classified according to cleanliness classes. An additional requirement for air exchange systems is that the reliability and stability of the supported parameters is more critical than the reaction rate and temperature adjustments. 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 standby lighting, and, therefore, rather favorable conditions for the development of mold and other microorganisms. This problem can be solved by introducing a denser network of smaller ducts instead of using a centralized air supply and centralized exhaust.

Cooling system

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

The system for maintaining temperature when the power supply is interrupted

The issue of maintaining given conditions in emergency it is extremely important in the design and construction of warehouse space, as it directly affects the stability and compliance with the parameters for warehouses within the GDP. It should also be noted that as part of the initial validation of a functioning warehouse, a preservation test of the set parameters in the event of an emergency lack of power supply should be carried out, a period of guaranteed preservation of conditions should be set and a period after which product verification and re-validation of the warehouse should be performed. Also, a separate ventilation system for warehouses will allow using uninterruptible power supplies only to supply the most critical systems in the event of an accident. Instead of maintaining all systems at a reduced level of energy consumption with the risk of disruption for each of the ventilation systems.

Monitoring system

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

Fire systems

Taking into account the realities and requirements of Russian legislation, the requirements for a complex of fire-fighting measures and the systems with which warehouse areas are equipped make up a rather vast area. It should only be noted that fire-fighting systems (fire extinguishing, warning and evacuation systems) should be assessed in terms of risks for both the product and the personnel, but at the same time, with a dismissive approach to design and coordination in the Ministry of Emergencies, it should be understood that the absence 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 facilities). But in this section there are nuances that allow you to use alternative approaches and solutions. An example is the fully automatic system for moving pallets in a warehouse, and the restriction of personnel access directly to the area of \u200b\u200brack storage. In this case, it is possible to use systems to lower the level of oxygen in the warehouse air, and thus reduce the fire extinguishing pipelines, as well as the volume of fire prevention measures. But, once again, I repeat that the primary task in designing and creating a warehouse from the point of view of fire prevention is to coordinate fire systems in supervisory authorities.

According to the requirements of cGMP and GDP (Good Documentation Practice) and qualification of processes must be provided in advance, retrospective validation is not allowed, therefore, a validation plan for both the warehouse separately and as part of pharmaceutical production must be provided in advance at the design stage and agreed with the service quality assurance manufacturer. The main task is to fully comply with all the requirements of good practices for the constancy 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, agreed with the quality assurance service, indicating the deadlines for completion, the dates for repeated validation activities and possible risks. In the ideal case, 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 go through all stages of qualification and be contained in all documents that regulate, control and standardize the procedures associated with the use of storage facilities.

Staff

The requirements for personnel associated with any processes in the pharmaceutical warehouse (such as the movement of finished drugs, control of auxiliary processes, and workflow) do not differ from the requirements for personnel in the pharmaceutical industry, in addition, that a responsible person should be appointed at the warehouse, responsible (by analogy with the authorized person) for the quality of each series of products passing through the warehouse.

Documentation

Requirements for documentation that regulates the activities of storage facilities are absolutely identical to the requirements of Good Documentation Practice for any other pharmaceutical industry and should include full traceability, change control, control of non-compliance and other aspects. It should be noted that the introduction of a sufficient system of proper document management is one of the most important aspects that allow the warehouse to pass validation and qualification before putting it into operation, and the state of the document management system should not be overlooked when creating a warehouse.

In conclusion, it can be noted that a separate pharmaceutical warehouse complex within the pharmaceutical supply chain or in the pharmaceutical industry, regarding the requirements for ensuring quality and functioning, cannot and should not differ from pharmaceutical production. Some aspects of the functioning of the warehouse are controlled even more strictly than during production, and losses due to improper fulfillment of quality assurance requirements can be extremely painful for the manufacturer / distributor both in terms of loss of series and reputation, and this is not even about fines of regulatory authorities , and about the safety of consumers, staff. Therefore, despite the external simplicity of organizing a warehouse complex, it is necessary not to reduce the requirements for design and creation, but to try to analyze the maximum possible risks at the initial or intermediate stages in the process of release and circulation of medicines 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 equipment for a pharmacy warehouse
4.	The movement of goods in the pharmacy warehouse:
	4.1.	Reception of goods
	4.2.	Quality checking
	4.3.	Placement of goods at the places of storage (video film)
	4.4.	Vacation of goods from the storage department.

1 . To fulfill the main tasks facing the wholesale link of goods distribution, warehouses are created that function independently as entityare either structural units distributor.

Warehouses - This is a building, structures and various devices intended for the reception, placement and storage of goods received at them, their preparation for consumption and release to the consumer.

^ Pharmacy warehouse It is organized for the purpose of supplying medicines, medical devices and other goods to pharmacy organizations, hospitals and other organizations and enterprises.

The main tasks of the pharmacy warehouse are: reception, storage and dispensing to pharmaceutical organizations, as well as pharmaceutical manufacturing enterprises Medicines, medical devices, pharmaceutical equipment and inventory that meet all quality requirements under applicable law.

Pharmacy Warehouse Features:

concludes contracts with suppliers;
carries out the procurement of pharmaceutical assortment goods and medical devices;
conducts claims and claims work, imposes penalties to suppliers in case of violation of contractual obligations;
carries out the reception of drugs and medical devices from suppliers in terms of quality, quantity and cost;
organizes storage of drugs and medical devices taking into account their physicochemical properties and the requirements of the Global Fund;
ensures safety and accepts orders from pharmacies, hospitals and other institutions, as well as pharmaceutical enterprises for the packaging, acquisition and timely delivery of drugs and medical devices;
organizes strict compliance with the accounting and dispensing of pharmaceutical, parapharmaceutical and other goods;
complies with labor protection and safety requirements.

To carry out the main functions, managers of the pharmacy staff

Warehouses are required to follow the regulatory documents governing its activities, to study supply and demand in the pharmaceutical market, to comply with the certification and control procedures, and the execution of relevant documentation.

^ 2. Pharmacy warehouse can be located in a separate 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 placing a warehouse in a building for medical or pharmacy purposes, the administrative and household 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 should have power supply, heating, water supply, sewage systems, supply and exhaust ventilation. The decoration of the premises (the inner surface of the walls, ceilings) should be smooth, allowing for the possibility of wet cleaning using disinfectants.

The possibility of access by unauthorized persons to production facilities should be excluded.

The composition of the pharmacy warehouse includes the following production facilities and areas:

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

2. storage department - storage of goods, sets of orders of pharmacies and healthcare facilities;

3. expedition department - packaging of goods and delivery to pharmacies and hospitals;

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

5. accounting - accounting documenting business operations of a pharmacy warehouse.

^ In the front desk it is necessary to provide zones:

Unloading, unpacking and sorting the arrived goods;

Temporary storage of drugs of domestic production;

Temporary storage of imported goods;

Movement and placement of means of mechanization and transportation;

Checking drugs (solutions, including for injection) for the absence of mechanical impurities;

Temporary storage of goods for complaint.

The reception department should be isolated from other rooms, but interconnected with the premises of the main storage of medicines.

In storage rooms, medicines can be placed: on racks, on standard pallets in factory containers, on commodity containers, in containers of elevator racks (small goods).

The number of storage rooms depends on the groups of drugs that require isolated placement.

Traditionally, regardless of the volume of work of the warehouse, the following storage departments are provided for: dry medicines, liquid medicines, finished medicines, sanitation and hygiene products, dressings, toxic and narcotic drugs (if there is a license for their storage).

The expedition must provide for the following main areas:

For the placement of goods prepared for shipment;

For the movement of means of mechanization (transport);

For storage of in-vehicle vehicles.

^ 3. Equipment and equipment warehouse

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

pharmacy warehouse:

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

Distillers;

Drying ovens;

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

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

^ 4. The movement of goods In a warehouse it consists of the following operations: unloading, acceptance for storage, quality control, placement at storage locations, and the release of goods from storage departments.

^ 4.1. Reception of goods . Reception of goods, incl. Medicines are carried out by the reception department of the warehouse in accordance with regulatory documents.

For the acceptance and transfer of received products to the appropriate departments at each pharmacy warehouse is created selection committeeconsisting 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.

Acceptors must be familiar with the rules for accepting products in terms of quantity, quality and cost, the basic and special conditions for the supply of medical products, the physical properties of drugs, their form of 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 delivered quantity, 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 reception department should be carried out in the presence of the heads (deputies) of those departments to which the goods will be transferred.

Delivery of goods is carried out in accordance with the contract. Under the contract, one or more consignments of goods may be received.

The consignment (at wholesale bases, warehouses and in retail) - products of the same name, received on one transport document, waybill or invoice.

Before starting acceptance, you must pay attention to the shelf life of the drug.

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

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

Special delivery conditions determine the remaining expiration dates, according to which drugs should be shipped by the manufacturer in such a way that at the time of their shipment, at least 80% of the expiration date indicated on the label remains, and for bacterial preparations, dental and polymeric materials - at least 5 -% expiration date.

When shipping the specified products from the warehouse to retail chain and health care facilities, the remaining shelf life should 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. Products with a shorter shelf life may be delivered by agreement with the buyer, which is determined by contractual terms.

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

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

Batch number Is a digital, alphabetic or alphanumeric designation that specifically identifies a series.

The valid options for specifying the expiration date are: “Shelf life until X 04” or “until X 04”.

^ An example of decoding a series of drugs :

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 for quantity and quality.

^ Acceptance by quantity . When accepting packaged domestic and imported goods by quantity, it must be taken into account that their quantitative characteristics include the mass of the goods (net) and packaging (containers). Received goods may be packaged and not packaged. If the goods are packed (boxes, boxes, etc.), then their acceptance begins with the determination of the gross mass.

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

Gross mass can be determined in several ways:

Direct outweighing of all packaging units included in the consignment;

By calculation (multiplying the average gross mass of each packaging unit by their total number) in case all packaging units of the batch have a fixed (identical) 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 \u003d M b - M t, where M t is the mass of the package.

^ Quality Reception . Acceptance of products by quality and completeness (the latter is provided for some medical devices) is carried out after acceptance of products by the number of seats and gross weight.

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

All drugs entering pharmacy and medical institutions from pharmacy bases (warehouses) of various forms of ownership and departmental subordination are subject to control.

Medicines that have certificates of conformity duly issued, issued upon receipt at the destination, are subject to selective control for certain indicators: description, packaging, labeling.

^ Drug Control Indicators

Index	Content Control
Description	Check appearance, color, smell
Packaging	Checking the integrity of the package and its compliance with the physicochemical properties of drugs
Marking	Compliance with the labeling of primary, secondary and group packaging, the presence of a leaflet in Russian in the package (or separately in a pack for the entire number of drugs); proper packaging of toxic and narcotic drugs. Medicines intended for the manufacture of injectable solutions should have the indication “Suitable for injection”.

In addition, drugs for injection and eye drops are subject to mandatory serial control for compliance with the requirements of regulatory documentation on pH indicators and mechanical impurities.

Medicinal plant material (LRS) (each batch) is checked by indicators: authenticity, fineness, impurity content, degree of infection with barn pests. Briquettes are additionally tested for strength and disintegration. In addition, each batch of LRS is tested for radioactivity.

In cases requiring quality control of drugs, in the prescribed manner, the number of checked packaging units in the consignment is determined and the necessary sample is taken.

Samples taken are transferred to the laboratory located in the warehouse, or to the laboratory with which the contract is concluded. Transfer of goods to main storage is carried out after receiving laboratory tests or an expert opinion.

^ 4.3. Placement of goods at the places of storage (video film)

4.4. Vacation of goods from the storage department. Goods are dispensed to pharmacy organizations, hospitals and other purchasing organizations on the basis of orders placed in accordance with contracts, in writing, by telephone, fax or using other means of communication.

The persons responsible for the shipment of drugs provide each order for drugs with accompanying documents and control the availability of all necessary information in the shipping documents. Such documents may include waybills, invoices, etc.

To complete the order in the picking area, work tables or roller conveyors with installations controlled by pickers are equipped. Small batches of drugs should be packed in a packaging container, standing on tables or conveyor. Filled boxes with medicines are installed on the conveyor behind the container.

At the end of the tables or conveyor there is a controller who checks the accuracy of the order picking by the order printout received by him.

Containers with orders are delivered on an expedition.

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

From the expedition, after checking the inviolability of the seal and accompanying documents, the container with the order arrives on the ramp in the box or zone where the machine is fitted to be sent to the customer.

The movement of goods in the warehouse is carried out in strict accordance with the current documentation on the accounting of goods and control in all departments of the warehouse. In the storage departments for each inventory item, a quantitative account should be made. Based on the accounting documents drawn up in the established manner, the materially responsible person of the warehouse is obliged to note the arrival and consumption of goods.

Appendix No. 1

An approximate list of necessary equipment

pharmacy warehouse:

racks, pallets, merchandise;
refrigerators for storage of thermolabile substances;
mechanization equipment for loading and unloading;
instruments for recording air parameters;
lockable metal cabinets (safes) for storing certain groups of drugs, accounting records and reference books;
work tables and chairs;
cabinets for separate storage of special and outer clothing and shoes;
disinfectants and equipment for ensuring the sanitary regime;
when carrying out the function of packaging, additionally necessary:

- weighing devices checked in the prescribed manner;

Distillers;

Drying ovens;

Other equipment in accordance with established requirements.

Appendix No. 2

SLIDES

(multimedia presentation)

Appendix No. 3

VIDEO

“Storage of drugs and medical devices at the pharmacy warehouse”

^ ACTUALIZATION OF THE TOPIC

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

Let's recall from the previous topics:

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

Who represents the wholesale distribution chain?

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

Therefore, a modern pharmacist must know the basic requirements of the organization of pharmacy warehouses, know the regulatory and technical documentation that regulates their activities, know the rules for storing medicines, medical devices, parapharmaceutical products.

Designing a pharmacy warehouse - laborious processwhich can be performed after identifying a clear need for medicines and medications. Before we reveal all the nuances of designing a pharmacy warehouse, let's decide what a pharmacy warehouse is and what functions it performs.

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

Urban
District
Regional
Federal

The owner of a pharmacy warehouse can be a state or a private person (company). The ownership form of the pharmacy warehouse was approved by 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, where the methods and terms of payment are agreed.

The main tasks of the pharmacy warehouse: reception, storage and dispensing to pharmacy organizations, medical institutions and other organizations, as well as pharmaceutical manufacturing enterprises of medicines, medical devices, pharmaceutical equipment, medicines, pharmaceuticals and equipment that meet all quality requirements in accordance with current legislation. To organize the work of the pharmacy warehouse, you will need a business plan that will outline the functions of employees, regulationsregulating their activities, studied the supply and demand in the regional pharmaceutical market, took into account the procedure for certification and quality control of goods, and also determined the conditions for the preparation of necessary documentation. Without a business plan, designing a pharmacy warehouse will be much more difficult.

Designing a pharmacy warehouse begins with a study terms of reference (TK) of the customer, which should take into account:

The operating mode of the pharmacy warehouse
Area, dimensions, dimensions of the prefabricated building
Location of the pharmacy warehouse
The main purpose of the interior (administrative, industrial, domestic, etc.)
Volumes of stored goods in stock
Acceptance and marketing areas for pharmaceutical products
Storage conditions for goods (normal and special)
The mode and conditions of the expedition

The project owner will need a forecast of demand for the products of this pharmacy warehouse, as well as the estimated breadth of the range and volume of products sold. After careful processing and analysis of all the data obtained, the design of a pharmacy warehouse will be organized. We note right away that the area of \u200b\u200binternal premises will depend on the general size of the warehouse, the mode of operation and the number of employees. The design of the pharmacy warehouse is carried out in accordance with applicable sanitary standards and rules (SNiP). The layout of the wholesale pharmacy warehouse includes general administrative and domestic internal premises. Separate internal premises are provided in the retail and wholesale and retail pharmacy warehouse. Warehouse space in both wholesale and retail warehouse must be separated from the administrative and other premises, have a separate entrance, driveway, ramp for unloading goods. Wholesale drug stores can receive products for wholesale from manufacturers or other wholesale companies, institutions, organizations (foreign or domestic), various ministries.

Despite the fact that the pharmacy warehouse, to a greater extent, is engaged in the procurement and sale of pharmaceutical products, the design of the pharmacy warehouse belongs to the production type of design, which we wrote about in the section "Special Offers". We offer turnkey pharmacy warehouse design, which includes:

Architectural project
Design project
Engineering project

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

- 274.00 Kb

State educational institution of higher professional education Nizhny Novgorod State Medical Academy of the Federal Agency for Health 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: Kononova S.V.

N. Novgorod, 2009

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

Theoretical part.

Regulatory legal documentation …………………………………………… .4

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

Organization of the work of the pharmacy warehouse ...................................... 6

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

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

Inspections of pharmacy warehouses ……………………………………………… ..11

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

The movement of goods in the pharmacy warehouse ……………………………………… ..19

Automation of goods distribution management in a pharmacy warehouse ... ... .22

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

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

The practical part.

Pharmacy warehouse - warehouse of the Pharmacy Holding group of companies .......... 33

Distribution Companies ……………………………………………………… 36

Algorithm for the acceptance of goods .................................................................................. 39

Conclusions ………………………………………………………… 48

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

Used Books…………………………………………………. .50

Introduction

An important part of healthcare is the pharmaceutical service, which is designed to provide the population with timely and high-quality medical care. The objective of the pharmaceutical service is to more fully meet the needs of the population and healthcare facilities for medicines, develop a network of pharmacy institutions, increase the level of training and improve pharmaceutical personnel.

The general availability of drug care is ensured by the development of a network of pharmacies and drugstores as close as possible to the population.

The joint work of doctors and pharmacists to determine the need for medicines and the distribution of 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 ensure drug pharmacies, 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. Warehouses are located in such a way as to ensure a functional relationship between all parts of the warehouse.

Regulatory documentation.

The procedure for carrying out pharmaceutical activities in the wholesale sale of medicines in 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 legal status provided for by the Civil Code of the Russian Federation.
According to this standard, drug wholesale is carried out only if there is a license issued in the prescribed manner. Information about the number, validity period of the license and the authority that issued it is placed in convenient places for familiarization. A pharmaceutical wholesaler should have a sign that displays information on the legal form of the enterprise, its company name, location (legal address) and mode of operation. As part of the premises of the wholesale enterprise, storage facilities (pharmacy warehouse) and administrative and household premises should be provided. The area of \u200b\u200bthe warehouses of the main industrial purpose must correspond to the volume of stored goods per unit of storage area, including the areas of acceptance of products, the main storage of drugs, a room for drugs requiring special conditions storage (thermolabile, narcotic and psychotropic, poisonous and potent, etc.), expeditionary. When designing pharmacy warehouses, the accuracy in calculating warehouse space largely depends on the correct forecast of demand for the products of this warehouse and determining the required stocks (expressed in real 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 \u200b\u200badministrative premises depends on the number of personnel and is calculated in accordance with applicable sanitary norms and rules (SNiP). If the warehouse of the drug wholesaler is located in a building for medical or pharmacy purposes, the administrative and utility 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 of pharmacy organizations of medical institutions and other organizations and enterprises.
The main tasks of the pharmacy warehouse is the reception, storage and dispensing of pharmaceutical 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 applicable law.
In accordance with the main objectives of the pharmacy warehouse performs the following the functions:

concludes contracts with suppliers;
carries out the procurement of pharmaceutical assortment goods and medical devices;
conducts claims and claims work, imposes penalties to suppliers in case of violation of contractual obligations;
carries out the reception of drugs and medical devices from suppliers in terms of quality, quantity and cost;
organizes storage of drugs and medical devices taking into account their physicochemical properties and the requirements of the Global Fund;
ensures safety, accepts orders from pharmacies, medical and preventive and other institutions, as well as pharmaceutical enterprises for the packaging, acquisition and timely delivery of drugs and medical devices on orders;
organizes strict compliance with the accounting and dispensing of pharmaceutical, parapharmaceutical and other goods;
exercises control at all stages of production activity;
provides control over the expiration dates and being in stock, the shipment of drugs and medical devices, their timely implementation taking into account the expiration dates, as well as compliance with price discipline in the supply and settlements with suppliers and consumers;
complies with labor protection and safety requirements.

To perform the basic 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, comply with certification and quality control procedures, and the preparation of relevant documentation.

Organization of the pharmacy warehouse.

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, acceptance, storage, picking and delivery of orders. When carrying out loading and unloading operations, incoming cargo must be protected from atmospheric precipitation, exposure to low and high temperatures.
Wholesale enterprises can receive products for wholesale from manufacturers or other wholesale organizations that may belong to different ministries, be foreign or domestic. They can also sell (transfer to disposal) drugs to other wholesalers, manufacturing enterprises for production purposes, pharmacy organizations and institutions, research institutes, individual entrepreneurs licensed for medical activity. The assortment of pharmaceutical wholesalers may include pharmaceutical products - medicines (including homeopathic ones) and medical devices, parapharmaceutical products (hygienic and cosmetic products, biological food additives, etc.), as well as other products traded on the pharmaceutical market (medical instruments, substances, etc.). Medicines sold on the territory of the Russian Federation must be registered in the prescribed manner. It is forbidden to sell drugs that have fallen into disrepair, expired and rejected during the certification process.

Warehouse premises.

The warehouse may be located in a separate 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 placing a warehouse in a building for medical or pharmacy purposes, the administrative and household 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 should have power supply, heating, water supply, sewage systems, supply and exhaust ventilation. The decoration of the premises (the inner surface of the walls, ceilings) must be smooth, allow the possibility of wet cleaning using disinfectants, while the use of unpainted wooden surfaces is not allowed; decoration materials must comply with established requirements. Additional requirements are imposed on floor coverings with regard to resistance to the effects of mechanization, wet cleaning using disinfectants, and the absence of dust-forming action. In the warehouse, it is necessary to allocate a special isolated place for storage of detergents and disinfectants, equipment and materials used in cleaning rooms, processing equipment, and a dressing room. In the dressing room, outer clothing and shoes are stored in isolation from removable special clothes and shoes.

When carrying out loading and unloading operations, incoming cargo 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 \u200b\u200bthe storage area. Its main functions are the reception of goods in quantity, completeness and quality; completeness and quality; verification of supporting documentation; claim work; distribution of goods by storage location in accordance with the methods and conditions of storage of individual groups of goods used in the warehouse. In addition, the product sampling functions may be assigned to the quality analysis; packing of goods, acquisition 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 meet the order, do not have the necessary supporting documentation, as well as those for which there is an assumption of their contamination, are appropriately labeled and placed in a specially allocated (quarantine) zone separately from other drugs 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.

Storage facilities for narcotic drugs, psychotropic substances, toxic and potent substances must comply with the established requirements (see Order No. 330 of 11/12/1997).
The possibility of access by unauthorized persons to production facilities (the part of the warehouse intended for receiving, sorting, storing, picking, 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, monitoring shelf life, 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 - shelving, on pallets in containers, etc. Two indicators play a role here: the utilization rate of the storage area (an indicator characterizing the ratio of the area occupied directly by the cargo to the total area of \u200b\u200bthe cargo area) and the utilization ratio of the storage volume (the indicator characterizing the ratio of the volume occupied by the cargo to the cargo volume of the storage area). Depending on the chosen method of storage and 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, in the storage areas of the pharmacy warehouse, orders are also completed and transferred to the expedition department.

Description

Theoretical part.

Regulatory legal documentation …………………………………………… .4

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

Organization of the work of the pharmacy warehouse ...................................... 6

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

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

Inspections of pharmacy warehouses ……………………………………………… ..11

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

The movement of goods in the pharmacy warehouse ……………………………………… ..19

Automation of goods distribution management in a pharmacy warehouse ... ... .22

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

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

The practical part.

Pharmacy warehouse - warehouse of the Pharmacy Holding group of companies .......... 33

Distribution Companies …………………………………………… 36

Algorithm for the acceptance of goods ..................................................... 39

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

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

Used Books…………………………………………………..

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