Every entity operating at the wholesale level of the medicinal product supply chain is obliged to implement the principles of Good Distribution Practice (GDP). This is especially true since 2002, when GDP became part of the legal system, thus becoming an enforceable reality subject to detailed supervision and control by the pharmaceutical inspection.
Currently, GDP is perceived as a set of rules presenting the proper conduct for every entrepreneur involved in the logistics of pharmaceutical wholesale. The term “wholesale” has been broadly defined in the Pharmaceutical Law as any activity consisting of procuring, storing, supplying, or exporting medicinal products to authorized entities, excluding the direct supply of the population. In other words, GDP is a set of guidelines for the organization of wholesale entities, describing at a certain level of generality the processes that should take place within these entities. The purpose of implementing GDP was to create requirements for the pharmaceutical storage and transport environment, guaranteeing proper conditions for moving, as well as receiving, storing, and dispensing medicines. The currently applicable rules are presented in the Regulation of the Minister of Health of July 22, 2002, on Good Distribution Practice procedures (Journal of Laws 2002, No. 144, item 1216). In legal terms, Good Distribution Practice includes:
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maintaining the proper technical and sanitary condition of the pharmaceutical warehouse premises,
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principles for the storage of medicinal products,
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principles and procedures for receiving and dispensing medicinal products,
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conditions for the transport and loading of medicinal products,
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proper management of a pharmaceutical warehouse,
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the method of entrusting the substitution of the warehouse manager as a qualified person responsible for managing the warehouse.
Currently, in Poland, the drug distribution market is dominated by two wholesale models: the first model, based on distributing drugs from a warehouse, and the second model, based on distributing drugs using a consignment warehouse as a place for storing and shipping pharmaceutical products. Since the Pharmaceutical Law in Art. 72 point 2 equates pharmaceutical warehouses with consignment warehouses in legal terms, GDP principles must be implemented and followed in both pharmaceutical warehouses and consignment warehouses. Therefore, for simplicity, in the following part, the definition of “warehouse” also includes consignment warehouses.
Pharmaceutical warehouse premises
According to GDP, a pharmaceutical warehouse must consist of at least:
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a receiving area, where the receipt of products is controlled in terms of quality and quantity
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a storage room for keeping products, guaranteeing the achievement of temperature conditions specified in the relevant product registration certificates
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a dispatch room, i.e., a shipment release chamber
and:
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an office room dedicated to the warehouse’s administrative staff and its manager, and a social room.
Receiving and dispatch chambers must have separate entrances, and in the aforementioned warehouse storage rooms, there is an obligation to define communication routes appropriate to the nature of the tasks performed. The layout of the routes is decided by the entrepreneur running the warehouse.
General conditions for drug storage
The rooms where medicines will be stored and their surroundings must be kept clean by introducing appropriate procedures guaranteeing the maintenance of proper warehouse hygiene. It is also necessary to ensure – primarily in the process of receiving and dispensing the product – its effective isolation from external conditions. The surface area, volume, and technical infrastructure of the storage rooms must be adapted to the assortment handled and properly equipped with:
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ventilation devices guaranteeing a legally compliant room ventilation process,
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thermoregulation devices, i.e., automation ensuring the maintenance of proper product temperature conditions,
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legalized (calibrated) instruments enabling 24-hour monitoring and recording of temperature and humidity. In practice, this is an integrated system of temperature sensors placed in various parts of the warehouse (at different heights), connected wirelessly or via cable to a central computer recording data read from the sensors.
The article comes from the magazine “Logistyka” 6/2010.