Proceedings of the Council for Pharmaceutical Excellence



The Council for Pharmaceutical Excellence (CPE) was formed to emphasize the importance of good science and engineering in the manufacture and analysis of pharmaceutical products. Our goals are to promote the use of sound, scientifically based technologies, engineering principles, manufacturing practices and effective quality assurance strategies for pharmaceutical products within a regulated environment. Central to these goals is the development of formal comments and position statements in response to regulatory guidance documents which impact those areas. The CPE believes that overly prescriptive regulations have handicapped the industry in numerous ways and thus have severely curtailed the use of sound science for further innovation and process improvement.

 

This compilation of position papers, technical articles and internet posts represents the first Proceedings of the CPE. Herein, we present the views of Council members on subjects including manufacturing practices, Low Endotoxin Recovery, and commentary on draft EU Annex 1. Our stated opinions seek to improve the quality of pharmaceuticals and biopharmaceuticals while simultaneously reducing cost and improving patient safety.

 

Please click or touch "Proceedings Vol. 1" on the left to access Volume 1, which can be downloaded as you wish.