Guidance For Quality Systems Approach To cGMP Regulations By Christine Park, Quality Architech
Why should pharmaceutical companies consider implementing a systemic approach to manufacturing and quality? The 21 CFR Parts 210 and 211 regulations provide direction for specific tasks and requirements to manufacture pharmaceutical products. But these regulations do not mandate integration of the activities or documentation of the interrelationship of these key processes to each other.
Decontamination: Hydrogen Peroxide Vapor (HPV) vs. Ultraviolet Radiation (UVC) By Bioquell Inc.
The fundamental differences between these technologies, in terms of their mode of antimicrobial action and the method of delivery, result in a marked difference in microbiological impact. Bioquell HPV eradicates pathogens on hospital surfaces and achieves a 6-log sporicidal reduction in vitro.
Maintaining a controlled room temperature (CRT) during transport is more complex than it sounds. In this white paper, find out how UPS's unique temperature-sensitive services and global network make UPS the obvious choice for products that require safe, consistent temperature throughout the supply chain. Learn more.
Streamlining Particle Count Data Management: White Paper Pharmaceutical cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent-cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt to remain both competitive and compliant with U.S. Food and Drug Administration (FDA) regulations.
Faster Time-To-Market: Case Study In the past, numerous departments at P&G were part of the verification process. For example, artwork traveled through marketing, production, legal, regulatory, consumer relations, print production, product development, and creative services.
Quality In The Global Pharmaceutical Supply Chain: White Paper Supplier quality has been a prime topic at recent industry conferences. Original equipment manufacturers (OEM), material suppliers, and contract manufacturers attended to listen to the implications and driving forces behind the scrutiny of our supply chain.