Vol. 8, Issue 6 (2019)

Author(s):
Manish Kumar Mishra and Pooja Kumari

Abstract:
The present article focus on the Introduction of Validation and common outline on process validation in pharmaceutical industry. The word validation defined as “Validation is documented evidence that provides high degree of assurance”. Validation has become one of the important pharmaceutical industries accepted subjects. The process is evolved in such a way that all the given parameters are reached and it ensures that the output of the process will always meet the required parameters during regular production. Validation and quality assurance will go hand in hand, ensuring the through quality of the products. Process Validation highlight on process design elements and keeping process control during commercialization and link that process validation is a constant program and line up process validation activities with product lifecycle. The validation protocol includes inventory control and equipment inspection in the preliminary steps and in-process controls in the subsequent steps. Process validation also highlights the role of objective actions and statistical tools and examines and underlines knowledge, detection, and the control of inconsistency and gives assurance on consistent of quality throughout life cycle of product.