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V 10 October 2015 Tablets & Capsules validation The four pillars of pharmaceutical validation Parveen Bhandola Validation Edge This article explains the four fundamental principles of validation: product and process understanding; data-driven and statistically supported action; multidisciplinary and broad-based methodology; and a holistic approach. With these universally applicable princi- ples, you can develop compliant, effective, and efficient validation programs that suit any situation and that will comply with regu- latory expectations. alidation is an integral part of the quality systems used in the life-science industry. Though the basic principles of val- idation haven't changed, how we approach validation and the regulatory expectations have evolved over the years, especially since the FDA published "Guidance for Industry—Process Validation: General Principles and Practices" in January 2011 [1].