Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

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. It is also not always clear how implementation into daily work can be performed for every requirement. How much is needed and what is necessary to meet the expectations of the GDP Inspectors.

On the GDP Association Webpage a section has been set up a while ago dealing with frequently asked questions (FAQs). It is planned to publish questions and answers to all chapters of the EU GDP Guide. Already last year FAQs have been published about the Scope of the Guide - and now FAQs have been released about Chapter 1 Quality Management. Answers to the following questions are available:

• Chapter 1 requires a Quality System. Is a Quality System according to ISO 9001 and the certification appropriate to comply with the requirements?
• What are the key requirements for a Quality System which is demanded by the EU GDP Guide?
• In the Supply Chain many logistic activities are outsourced to service providers e.g. transport and storage. Is it possible to agree a contract with the service providers so that they will be solely responsible also for the quality system and the quality of the medicinal product?
• According to Chapter 1.5 a Quality Risk Management should be in place. What is required also with regard to the necessary documentation?

Please read the FAQs on the EU Good Distribution Practice Guide.