Cleaning validation process in pharmaceutical industry

Abstract

Validation is the skill of designing and practicing the designed steps by the documentation. Process validation also highlights the role of objective measures and statistical tools & analyses and emphasizes knowledge, detection, and control of variability, and gives assurance of the consistency of quality and productivity throughout the life cycle of the product. According to GMP, validation studies are an essential part of the GMP; these are mandatory and done according to the predefined protocols. The process validation is established and gives a high degree of assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristics. The validation study gives the accuracy, sensitive specificity and reproducibility of the test methods employed by the firm which, which shall be accepted and documented , the validation is an essential part of the quality assurance. Validation is one of the necessary steps in achieving and maintaining the quality of the final product. If all the steps of the production process are validated, we can assure that the final product is of the best quality.