Vol. 7, Issue 3 (2018)

Author(s):
Kiranbala Jain and Meenakshi Bharkatiya

Abstract:
Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. Process validation is an essential component for the safety of drug product and also to maintain the quality of the product. Validation is establishing documented evidence which provides a high degree of assurance that a specific process for manufacturing of tablets will consistently produce a product meeting its pre-determined specifications and quality attributes. Validation and quality assurance will go hand in hand, ensuring the quality for the products. The present article gives an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process.