Abstract
Author(s): SR Parthasarathy* and PK Krishna Priya
This article outlines the general principles and approaches that are appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this article as drugs or products. This article incorporates principles and approaches that all manufacturers can use to validate manufacturing processes and cleaning processes. This article aligns process validation activities with a product lifecycle concept and encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.