Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

Protocols will form key part of company’s quality system. Bio-Matrix Scientific Group is entering the facility validation process arena. Working with company’s chief scientific advisor, Geoffrey ...

(MENAFN- GlobeNewsWire - Nasdaq) Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK ...

Applying DOE and Risk-Assessment Methods Early Eases Process Validation However innovative or compelling a novel manufacturing process may be, its value depends on the ability to validate the process ...

A medical device's package plays a key role in safely delivering treatment to patients. It must ensure the integrity of the device from the point of manufacture to the point of final use. In addition, ...

This document is a comment on the X PRIZE validation protocol written by Kedes et al. (2011). We propose several modifications which we think will improve the fairness and transparency of the contest ...

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as ...