In the Zone

Validation is defined as the "Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to the expected results." (EC Guide to Good Manufacturing Practice, 1997). It is a requirement of GMP that each pharmaceutical manufacturer identify the validation work required to prove control of the critical aspects of their operations. Any aspect of, including significant changes to, the premises, the facilities, the equipment or the processes, which may affect the quality of the product, should be validated.