GOOD WAREHOUSING

Definitions

Warehouse - A facility where company stocks are stored. In Pharma business, typically store raw material, packaging material, semi finished and finished goods.

Distribution - The process in which the finished drug product is moved from the initial warehouse to the final consumer. This process may involve several steps from beginning to end depending on the complexity of any manufacturing /marketing agreements.

Licences

u A potential warehousing and distribution organization must hold all

necessary local government licences covering the storage and/or distribution

of the relevant drug products.

u Deliveries should be made only to other authorized wholesalers or the person

authorised to supply medicinal products to the public in the country.

Personnel

u Key personnel who carry out supervisory and/or controlling functions relating to

warehousing or distribution should possess the necessary integrity, knowledge,

experience, and professional or technical qualifications appropriate to the task

assigned to them.

u The concept of the Responsible Person (RP) was introduced by the Directive

2/25/EEC. The RP should ensure that the conditions of the Wholesale Dealer’s

Licence are met and that the guidelines on Good Distribution Practice are

complied with.

u Personnel should be trained in relation to good storage and distribution practice and to the duties assigned to them. All training should be documented.

u The following aspects should be included in any formal training programme:

- Regulatory Requirements

- Standard Operating Procedures

- Record-keeping

- Security

- Storage Requirements

- Safety