GDP inspections by supervisory authorities have grown in number and intensity. Many partners in the distribution chain also have customer audits to face. What does the ideal preparation for a GDP inspection look like?
The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs). Please read more about the new Questions and Answers on GDP
The British Medicines and Healthcare Products Regulatory Agency (MHRA) has published a report summarising GDP inspection deficiency data from its 2016 inspections.
The US FDA published a form 483 criticising the shipping practice of a pharmaceutical company. They simply ignored temperature excursions and respective complaints.
Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.
The British Standards Institution (bsi), Group Japan, has developed a so called PAS (Publicly Available Specification) to specify requirements for temperature-controlled delivery services for chilled and frozen goods.
GDP Guidelines are certainly a hot topic in the EU and in WHO states. In the US, things are still developing but are getting more and more important, as the excerpts from recent Warning Letters addressing GDP isssues show.
The European GDP Association has been growing steadily since its foundation as Good Distribution Practice Interest Group in 2013. Now it represents close to 1.900 professionals from all over the world. Recently the Association announced that two new members joined the Advisory Board.
The trade press has extensively covered the counterfeit of Harvoni, a pharmaceutical produced by Gilead. The background circumstances as well as the consequences to be drawn from this incident are of interest here. Read more about the counterfeit case and the GDP consequences.
