Pharmaceutical Technology-09-01-2015

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Process analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

This special issue combines technical articles on leading pharma industry topics and a comprehensive preview of the upcoming CPhI Worldwide trade show

To enable efficient monitoring systems, life-science companies need to effectively apply run rules.

Click the title above to open the Pharmaceutical Technology September 2015 APIs, Excipients, and Manufacturing Supplement in an interactive PDF format.

This article discusses cleaning validation of equipment dedicated to the production of a single API.

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.