28/29 September 2021
The final GDP Guidance on Interpretation and Implementation has been published as a joint publication of the ECA Foundation and the Pharmaceutical Quality Group of the Chartered Quality Institute.
Although the 2013 EU-GDP guidelines provide far more details than previous guidelines, it is clear that there was and is a need for further guidance on the interpretation and implementation of the regulatory expectations. "Through our risk based inspection programme we regularly identify sites where their understanding of regulatory compliance presents them with a challenge", said Mark Birse (Deputy Director, Inspection, Enforcement & Standards Division, Head of Inspectorate, MHRA) in his foreword.
So both the PQG and the ECA Foundation with its European GDP Association started a project which began with the creation of a series of individual chapter guides which are all available for free for members of the European GDP Association. However it was always the intent to provide a single document - which has now been accomplished.
This document and its chapters are built around the format and text of the 2013 EU-GDP guidelines, providing a sound basis for the implementation and maintenance of a GDP quality system with clear responsibilities and processes and the application of risk management principles. It should be of benefit to all involved in GDP activities for initial training, continuing professional development and as a reference source or audit tool.
Mark Birse welcomes this ECA PQG GDP Guideline, "the outcome of significant work by a number of experienced professionals from across the EU, as it will no doubt assist in providing clarity and support for those operating with this sector".
Every participant of the ECA GDP Conference (Barcelona, 5/6 June 2018) will get a free copy of the GDP Guidance on interpretation and implementation. An interactive PDF of the document will be accessible in the members' area of the EGDPA website soon.