Food Safety

Total Quality Management (TQM)

Total Quality Management (TQM) refers to management methods used to enhance quality and productivity in business organizations. TQM is a comprehensive management approach that works horizontally across an organization, involving all departments and employees and extending backward and forward to Read more…

By Nia, ago
Pharma

Sterility Failure Investigations

The intent of this article is to provide practical advice based upon gaps that the author has observed during investigations into numerous sterility test failures. The approach described will also apply to other types of viable microbial contamination events, such Read more…

By Nia, ago
Pharma

Audit Trail Generation and Review

The audit trail is an integral requirement of an electronic record, ensuring the validity and integrity of the record and the link between any electronic signature and the record associated with it. Its regulatory requirements are fairly straightforward, but the Read more…

By Nia, ago
Food Safety

Health Canada Regulation

A multi-year consultative development process led to Canada’s Natural Health Products regulations, a system that most agreed would bear watching as a possible model for other regions where the distinctive characteristics of natural health products could be recognized and the Read more…

By Nia, ago