Products being used within their end-product application can suffer systematic or random failures. Functional safety standards are designed to help influence the reduction of potential risks of ...

This annex alone justifies the purchase cost of NFPA 70E, even though it’s just three pages. Arguably, the core of it is Table F.3. If you can grasp the thinking behind, and application of, Table F.3 ...

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 ...

Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.

The author describes key considertions for a complete risk-assessment model and provides insight into a pending IPEC guideline in this area. The primary focus of risk assessment for the use of ...

The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...