Moist heat sterilization is widely used for aqueous-based products. It's not used in instances where it results in product/material or packaging degradation. You must fully evaluate and document any ...

In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

Radiation sterilization is used mainly to sterilize heat-sensitive materials and products. However, many materials, drugs and packaging materials are also radiation-sensitive. This method is allowed ...