The Deeper, Darker Side Of Environmental Validation/Equipment Qualification

In our application notes and articles on validation, we usually stay at the level of principles and best practices because every application is different. The regulations published by the FDA and EMA, as well as other regulatory agencies such as SFDA and PMDA, are written broadly for just this reason: the needs of each product and the parameters of each environment will, more than any other factors, determine how you will apply the practices described in regulations and guidance.