When Do Guidelines Become Requirements?

Regulatory Update

MIQE Makes a Difference in PCR A guideline such as Minimum Information for Publication of Quantitative Real-time PCR Experiments (MIQE) is a good example of how a science-based guideline can impact customers and suppliers, becoming a kind of “voluntary regulation” which aims to improve the quality of laboratory research. Compliance with this guideline allows researchers and […]

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FDA Process Validation Guide Places New Emphasis on Understanding and Controlling Variation

Regulatory Update

The US FDA has issued revised recommendation for process validation which includes better means for understanding and controlling sources of variation. While this document refers to control of manufacturing processes, the same principles apply to measurement processes in the laboratory. In fact, it is impossible to demonstrate that a manufacturing process is in control unless […]

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