1.8.1 | Management of a storage facility |
Any storage area, which is not physically an integral part of the premises of a pharmacy, must constitute part of a pharmacy licensed by the Department of Health and recorded with Council. Such a storage area must fall under the authority of the responsible pharmacist of the pharmacy of which it forms a part, and be operated in compliance with Good Pharmacy Practice. Thus, such a storage area cannot exist/operate independently of a pharmacy.
1.8.2 | Condition of the storage area |
(a) | The walls, floors, windows, ceiling, woodwork and all other parts of the storage area must: |
(ii) | be kept in such good order, repair and condition as to enable them to be effectively cleaned and to prevent, as far as is reasonably practicable, any risk of infestation. |
(b) | Walls must be finished in a smooth, washable and impermeable material, which is easy to maintain in a hygienic condition. |
(c) | The storage area must have an air-conditioner in good working order; |
(d) | Light conditions, temperature and humidity within the storage area must comply with the requirements for the storage of medicine, other pharmaceutical products, raw materials and packaging materials. |
(e) | The temperature in the storage area must be below 25 °C. |
(f) | Storage areas must have sufficient shelving constructed from a smooth, washable and impermeable material, which is easy to maintain in a hygienic condition. |
(g) | Storage areas for Pharmaceuticals must be self-contained and secure. |
(h) | Storage areas must be large enough to allow for orderly arrangement of stock and proper stock rotation. |
(i) | No medicine may be stored on the floor. |
1.8.3 | Control of access to the storage area |
(a) | The pharmacist must ensure that every key, key card or other device, or the combination of any device, which allows access to a storage area when it is locked, is kept only on his/her person. |
(b) | Control of access to the storage area must be of such a nature that only a person authorised by the responsible pharmacist has direct access to medicine. |
(c) | A procedure must be in place to ensure access to the storage area in an emergency situation in compliance with the Occupational Health and Safety Act, 1993. |