Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...

Chemical regulations exist to safeguard human and environmental health throughout a substance’s life cycle (manufacture, intended use phase, and disposal). Regulatory decisions require scientific ...

Process designs and control strategies can be improved by adopting a risk-based approach to product quality. The author describes how this approach can be applied to spray-drying operations. Taking a ...

While the Occupational Safety and Health Administration's (OSHA) first standards for employers in 1971 were revolutionary for their time, they have since fallen by the wayside with the introduction of ...

This article is part of PharmTech's supplement "Injectable Drug Delivery." Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Because of the nature ...

BOSTON & DENVER--(BUSINESS WIRE)--ProcessUnity and CyberGRX announced today that the Third-Party Risk Management (TPRM) leaders have joined forces, creating the industry’s most powerful software and ...