What are the Requirements for Premises and Storage Facilities?
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Wholesale distributors must have suitable and adequate premises and storage facilities, to ensure proper storage and distribution of medicinal products.
Deficiencies in this area regularly come up in GPD Non-Compliance Report. For example, on 28 July 2022, the competent authority of Czechia (State Institute for Drug Control) has entered a report into the EudraGMDP database. It states that the company in question does not provide approved storage facilities. (Source: EudraGMDP Database, Inspection Date: 03. November 2021; Report Number: sukls279009/2021)*.
Against this background, the question arises as to what are actually the concrete requirements for premises and storage facilities according to the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01)?
Taking a look at Chapter 3 (premises and equipment), one finds mainly the following stipulations:
- suitably secure and structurally sound
- clean, dry and maintained within acceptable temperature limits
- free from litter and dust
- adequate lighting
- access restricted to authorised personnel
- protection from prevailing weather conditions
- clearly marked areas
- segregated areas, e.g. for products that have been removed from saleable stock
- adequate separation between the receipt and dispatch and storage areas
- no insects, rodents or other animals
- preventive pest control programme
- no presence of food, drink, smoking material or medicinal products for personal use
- control of environmental factors (e.g. temperature, light, humidity and cleanliness)
- availability of cleaning programmes, instructions and records
- initial temperature mapping exercise before use or an assessment of potential risk for small premises
* To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.