cGMPs and Compliance Resource Center
Can FDA Walk the Talk on Standards?
FDA’s Office of Product Quality needs a change agent. Ali Afnan has a suggestion.
cGMP Judgment Day
A look at recent FDA enforcement activities and lessons to be learned.
Managing Risk: GMPs Are Not Enough
Risk-based asset management offers a way to prioritize assets and reduce overall risk.
Managing Risk: GMPs are not Enough
Risk-based asset management offers a way to prioritize assets and reduce overall risk
White Papers: In Depth Research
Ensuring Quality & Regulatory Compliance When Collaborating with a Service Provider
Author: DPT Laboratories
With the FDA's heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices cGMP are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners.
Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations
A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing.
Reducing Airborne Contaminants with Polymeric Floor Coverings
A major medical device manufacturer has recently revealed significant airborne reduction counts. The facility based in the USA achieved this result by evaluating their contamination control methods at floor level.
Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry
This report by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) highlights the critical role of the FDA in today's biomedical research and innovation ecosystem, and the need for a strong, science-based agency and an efficient, consistent and transparent regulatory process.