What are the Requirements for Premises and Storage Facilities?

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

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.