GDP Audits

GDP – Good Distribution Practices

All links in the Drug Distribution chain (from manufacturing/import to dispensing) must comply with current regulations, given the impact they have on the quality of the drug. The new guidelines include the update of Directive 2011/62/UE (published in March 2013) and are mandatory from September 8, 2013.

Among the new aspects, we can highlight the need to have a robust quality system, based on risk analysis and the corresponding monitoring, the requirements for transport, the management of returns, the verification of suppliers, the figure of drug intermediation, etc. In November 2013, the regulations were updated and entered into force on November 24, 2013.


The Distribution of the Base Substances of the medicines must follow the principles of GDP in the different links to avoid conservation defects, adulterations and breakage of the pharmaceutical chain of protection of the medicine.

Since 2003, the World Health Organization, WHO, published the “Good Trade and Distribution Practices for Pharmaceutical Starting Materials” World Health Organization, WHO Technical Report Series, No. 917, 2003, setting the guidelines for a correct distribution of all substances that make up a medicine.

On this basis, the European Union has drawn up a draft Directive for Correct Distribution of Active Pharmaceutical Substances (API) and the International Council on Pharmaceutical Excipients, IPEC, have established Practices for the Correct Distribution of Pharmaceutical Excipients, IPEC GDP 2006.

AuditGMP Pharma has the necessary knowledge, experience and tools to audit the different parties that make up the distribution chain, with the main objective of ensuring correct compliance with Good Distribution Practices.