Pharmaceutical Process Validation: An Industrial Perspective

Quality is the primary reason for the industry for the products manufactured and validation has therefore become one of the most debated topic of recent times. Validation means confirming that a system or a product caters to its predetermined specifications so that the quality and safety of the product is ensured. It utilizes statistical tools for the analyses of the process logically so that a process is designed in a suitable manner that gives enough assurance that the product is consistent in quality throughout its lifecycle. Earlier, Process Validation (PV) was considered as a burden as it was thought that PV was only a regulatory requirement and was criticized by many. But, literature from previous three decades state that pharmaceutical process validation has evolved and now it is well accepted and regarded as a part of total quality and process management. Validation development is do so that the particular process delivers the product with its predetermined quality attributes and hence validation has become one of the regulatory perquisite for the grant of their manufacturing and marketing authorizations. Hence PV is one of the integral part of quality assurance and this article emphasises on process validation and its types, lifecycle approach and merits of PV.