Worst Case Scenario Simulation: The deeper, darker side of Environmental Validation/Equipment Qualification

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.Having said that, along with providing monitoring and validation systems, we enjoy delving a little deeper into some of the issues that come up in the validation applications of our customers and contacts. We often receive questions from customers in logistics regarding simulating a worst case scenario as a method for qualifying containers used to transport pharmaceuticals. In this article we discuss considerations for qualifying a transport container that will be used for regulated products like pharmaceuticals, medical devices, or biologicals/HCT/ps.

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Source:  Vaisala