14/15 December 2021
During several ECA events, the question came up whether it is allowed to take personal medication into the storage area.
According to chapter 2.5 of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), "appropriate procedures relating to personnel hygiene, relevant to the activities being carried out, should be established and observed. Such procedures should cover health, hygiene and clothing." Article 3.2 states that "rest, wash and refreshment rooms for employees should be adequately separated from the storage areas. The presence of food, drink, smoking material or medicinal products for personal use should be prohibited in the storage areas."
In a similar way, chapter 5 of the EU GDP Guidelines for Active Substances (Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use - 2015/C 95/01) states that "premises and equipment should be suitable and adequate to ensure proper storage, protection from contamination, e.g. narcotics, highly sensitising materials, materials of high pharmacological activity or toxicity, and distribution of active substances [...]"
That means that
As stated in the GDP Guidelines, no personal medication is allowed in the operational areas. Therefore, medication should be kept in lockers and not taken into storage and distribution areas. However, exceptions may be appropriate, e.g. allowing asthmatics to carry reliever inhalers with them. In this case, these exceptions for personal medication should be clearly documented following a risk-based approach.