Article: Improving Pharmaceutical Manufacturing Regulatory Risk

By ACSYS, Inc.

Pharmaceutical manufacturers must manage regulatory risk to ensure products are developed and produced in manner consistent with organizational goals and strategic objectives. Ongoing operations and marketplace supply can be hindered if a producer is not keenly aware of the regulatory environment and potential risks of underperforming processes. Operational requirements for development of clinical supply may also be adversely affected when regulatory issues exist. Similarly, drug development may be hindered by poorly performing production processes for managing laboratory testing, facilities and systems, quality and packaging/labeling.

Organizational regulatory risk management may become a competitive advantage for pharmaceutical manufacturers when applied in a way that ensures compliance and supports the operational/ production needs of the pharmaceutical producer. This report will address the regulatory risk of Current Good Manufacturing Practices (cGMP’s) through a review of regulatory trends over the past 12 months and also in a historical perspective of the past 4 years. A thorough review of all FDA activity in the area of cGMP’s provides insight into regulatory risks.

Used with permission from Acsys. For additional information, please visit www.acsys.org.