GDP – Buenas Prácticas de Distribución
All the steps on the Medicine Distribution chain (from the manufacturing/import to dispensing) should follow the current regulations, due to the impact that it may have in the medicine quality. The new guidelines include the updating of Directive 2011/62/EU (published on March 2013) and are in force from 8th September 2013. Among new items, it can be highlighted the need of having a robust quality system, based on risk assessment and the corresponding monitoring, transport requirements, returns management, suppliers verification, the figure of medicines intermediation, etc. In November 2013 the regulation was updated, coming into force on 24th November 2013.
The distribution of Medicine Active Substances should follow GDP principles in all the steps to avoid conservation defects, adulteration and the breakage of pharmaceutical medicine protection chain. From 2003 the World Health Organization, WHO, edited the “Good Trade and Distribution Practices for Pharmaceutical Starting Materials” World Health Organization, WHO Technical Report Series, No. 917, 2003, establishing the directives for a correct distribution of all substances being part of a medicine. Based on that, the European Union has developed a Project of Directive for the Good Distribution of Active Pharmaceutical Ingredients (API) and the International Pharmaceutical Excipients Council, IPEC, has established the Pharmaceutical Excipients Good Distribution Practices, IPEC GDP 2006.
AuditGMP Pharma has got the knowledge, experience and needed tools to audit the different parts of the distribution chain, with the main objective, of assuring Good Distribution Practices compliance.