Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently ...

The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.

A large-scale analysis of U.S. water quality data reveals that most toxic chemicals remain poorly characterized or undetected in routine monitoring. This is largely due to sparse risk assessment data, ...

Editor’s note: This article is the third in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. The new final standards on quality ...