GDP for Medicinal Products
It is of key importance that the
quality and the integrity of the medicinal products are maintained during the
entire supply chain from the manufacturer to the patient. Today’s distribution
network for medicinal products is increasingly complex and involves many
players. The revised guidelines, published today, lay down appropriate tools to
assist wholesale distributors in conducting their activities and to prevent
falsified medicines from entering the legal supply chain.
The revised 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)
Source: LinkedIn.