ECA/PQG Guides

GDP for Active Substances Guidance In June 2020, the Good Distribution Practice for Active Substances 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. 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.

GDP Guidance on Interpretation and Implementation 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. It started with the creation of a series of individual chapter guides which are all available as pdf for members of the European GDP Association (see below). However it was always the intent to provide a single document. 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. Click here to purchase the Guides at the PQG web shop. Benefits for members As a member, you may also download the ECA/PQG Guides in the form of an interactive PDF document. ECA EU GDP association members are entitled to a 30% discount when purchasing hard copies of the GDP books. The code needed may be found in the GDP Association Members Area.