The Pharmaceutical and Medical Device industries have many national and international regulatory requirements that they must satisfy to ensure that they are allowed to continue to manufacture and sell their products.
Satisfying the regulatory commitment is a very expensive process. All Pharmaceutical and Medical Device companies invest a large proportion of their operating budgets simply satisfying these regulatory requirements.
Validation is part of these regulatory requirements. The FDA defines validation “as establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
Simply put, this means to prove that a process, system or equipment will do what it is designed to do time after time every time.
Each Pharmaceutical or Medical Device manufacturer must validate its process and equipment before they can accept commercial sales.