The European GDP Association is quite active in supporting its members. What has been achieved in the past six months?
The Association has started a project with the Pharmaceutical Quality Group (PQG) of the Chartered Quality Institute to create a guidance document for interpretation and implementation of the GDP requirements for APIs. Work started in November 2018, with the aim to have the new document published in November 2019. Format and structure of the document will be the same as the GDP for finished products. For this purpose a Joint Venture Agreement between PQG and the ECA Foundation was established to clarify the roles, responsibilities and accountabilities of both the PQG and ECA in the delivery of this guideline on Good Distribution Practices for APIs.
The Association was contacted by the Japan Pharmaceutical Manufacturers Association, JPMA. They would like to publish Japanese translated material of the "Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline" into the periodical publications issued by JPMA. Permission was granted (JPMA to take responsibility for the accuracy of the translation)
The Code of Practice "The Responsible Person for GDP" has been revised and Version 2 is now available for members of the European GDP Association. Under the direction of Sue Mann, a small task force has worked on these updates to help ensure this document continues to be a useful resource for those working in this sector. In particular, the changes include more information on the expectations of the role and responsibilities of a RP in line with increased regulatory agency focus on the RP. Additionally, there is further guidance on data integrity expectations and more detail regarding different aspects of the role of RP where this can provide improved clarification of requirements and expectations.
Supported by Afshin Hosseiny and Wolfgang Schmitt, Prabjeet Dulai, Director of GDP & Quality Matters Ltd. has written an article for ECA's GMP Journal. It describes how to deal with Deviations in Storage and Transportation.