New GDP Monograph for Active Substances published

Recommendation

4/5 October 2023

The GDP Compliance Manager - Live Online Training

The Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. The monograph is based on the text of the European Commission "Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)", but is applicable to all sectors of the distribution network worldwide.

The document and its chapters are built around the format and text of the EU-GDP guidelines of active substances. The original text is quoted verbatim and appears contrasted in color. The monograph commentary provides:

• the rationale of each section of the quoted regulatory guidance
• discussion on the benefits and risks associated with each section
• recommendations regarding implementation

In addition, the document contains some figures providing diagrammatic representations, a glossary with abbreviations and definitions as well as a bibliography with useful links.

To order the publication as a booklet, go to the PQG website and select "Shop" from the navigation bar. Members of the ECA Foundation's GDP Association will receive a 30% discount by using a voucher code. The code needed may be found in the European GDP Association member's area. And if you are interested in the publication, but you are not a member yet, you can apply for membership using the application form.

An interactive PDF of the document will be accessible soon free of charge in the member's area of the European GDP Association.