Lessons Learned from the First GDP Inspections in the Netherlands Based on the New EU GDP Guidelines
This article, co-authored by Riekert Bruinink (Senior Inspector from the Dutch Healthcare Inspectorate), and CoolPack’s Technical Advisor Dr. Rafik Bishara, discusses the lessons learned from the first GDP inspections in the Netherlands based on the new EU GDP Guidelines.
It has been more than one year ago that the new EU GDP Guidelines came into enforced implementation. It is an improvement and a step forward over the previous 1994 Guidance2 as the new one better reflects the various changes in the distribution industry which occurred during the last 20 years.
In this article we will present results of the first GDP inspections at companies with a wholesale license based on the new guidelines. During the inspections in the first half of 2014 the focus was on the most important changes related to the previous Guidelines of 1994. The new GDP Guidelines had a lot of impact on the GDP level of most pharmaceutical companies, because of the increased requirements for the quality system, the Responsible Person, qualification and validation, returned goods and the maintaining of temperature during transportation of all temperature sensitive medicinal products. It was not possible to inspect all the new changes of the GDP Guidelines, so a selection of topics was made.
Source: Pharmaceutical Outsourcing