Pharmaceutical Technology-09-01-2014

Biopharma manufacturers must reduce risk in their complex supply chains and establish effective monitoring and control systems.

Changing regulations are impacting the identification and monitoring of variable materials in excipients.

New excipients and improvements to existing excipients are needed to facilitate access to new drugs for patients.

The quality and composition of excipients can vary due to environmental factors, processing methods, raw material quality, manufacturing location changes, and even operator actions.

FDA is moving in the right direction in terms of implementing stratification by levels of compliance across pharmaceutical manufacturing sites. However, quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.

Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.

API development and manufacturing companies expanded their capabilities, built partnerships, and achieved milestones in regulatory inspections.