The revised GDP guidelines introduce the following changes:
- the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
- suitable documentation which prevents errors from spoken communication;
- sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
- adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
- appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
- outsourced activities correctly defined to avoid misunderstandings;
- rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
- Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products).
Read more at: http://ec.europa.eu/health/human-use/good_distribution_practice/index_en.htm
The revised guidelines
will enter into force in six months from the date of publication, on 8 September 2013.