Tuesday, 18 January 2022 14.00 - 15.30 h
The primary role of the ECA European GDP Association is to support wholesalers and manufacturers placing human medicinal product on the market in the European Economic Area and the United Kingdom (or distributing from these locations) in complying with the requirements of the EU GDP Guidelines (2013/C 343/01) and relevant legislation.
The objectives of the group include providing
a platform for all personnel involved in the pharmaceutical supply chain and sharing best practices for product storage, transportation and distribution. In order to achieve these goals, various documents have been published in recent years. These include:
Code of Practice for Responsible Persons (RPs): The Code of Practice has been developed to support Responsible Persons according to EU GDP Guide 2013/C343/01. It provides information about the Responsibilities and Duties of RPs as well as recommendations for education and ongoing training. Finally, an example of a job description should help RPs to define their role in the supply chain of medicinal products.
Roadmap to Good Distribution Practice: The European GDP Association has compiled this document to support pharmaceutical and wholesaler businesses in implementing regulatory requirements and expectations in their quality systems. In addition, it provides checklists to verify the minimum implementation of GDP.
Guidance on the interpretation and implementation of European Good Distribution Practice: This document has been published as a joint publication of the ECA Foundation and the Pharmaceutical Quality Group of the Chartered Quality Institute.
This document and its chapters are built around the format and text of the 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.
Good Distribution Practice for Active Substances Guidance on interpretation and implementation: This document was also published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. Its chapters are built around the format and text of the EU GDP Guidelines of active substances. The monograph commentary provides
the rationale of each section of the quoted regulatory guidance, a discussion on the benefits and risks associated with each section, and recommendations regarding implementation.
Q&A Document: In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The European GDP Association has answered these questions and combined them in a Q&A document.
All these documents are accessible free of charge in the member's area of the European GDP Association.
If you are interested in the publications, but you are not a member yet, you can apply for membership using the application form. Membership is available at no cost. Once you are signed in, the documents will be available for you.