A review on process validation as an essential process

Abstract

The present article gives an introduction and general overview on process validation as an essential process for manufacturing pharmaceutical products. Process validation is an important component in the design, prototyping and manufacturing process and assures that a process will consistently produce product, meeting its predetermined quality characteristics and attributes. As quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. Also end-product testing by itself does not guarantee the quality of the product so quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.