ABSTRACT
If every batch coming off a production line could consistently reproduce a drug product meeting its predetermined specifications and quality characteristics, there would be very little need for validation. Unfortunately, in the real world of manufacturing, many factors combine to make each unit unique and, therefore, a need for validation exists. The U.S. Food and Drug Administration (FDA), the Health Protection Branch of Canada (HPB), the UK Medicines Control Agency (MCA) and several other regulatory bodies have defined validation in their
regulatory documents. Most definitions of validation will normally include and deal with, to a major extent, the aspects and concepts of "risk of a process not in control and the benefit (financial or otherwise) derived from a process in control."
