Minireview: Process Validation as Essential Tool in Pharmaceutical Industry
Sandip P Dholakia*1, Anil P. Valiya1, Tejas M. Thakar1,Jitendra S. Patel1, Madhabhai M. Patel1
1. Department of Chemistry, Shankersinh Vaghela Bapu Institute of Pharmacy, Vasan-Gandhinagar (Gujarat)
Process validation is an important tool in modern pharmaceutical industry. Validation gives a quality proof to the product which was manufactured under specified condition and quality parameter defined by GMP. The process validation is established documented evidence which provides high degree on assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristic. If each step of manufacturing process is validated, we can assure that the final product is of desire quality. Validation of the individual steps of the processes is called the process validation. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test. This article covers Introduction, type of validation, Phases of Process Validation, Documentation, SOP, Validation Master Plan and Validation Protocol. Validation is an integral part of quality assurance, during the formulation of any product quality has always been an important factor and therefore training is required before moving on at every step such as manufacturing material, equipment, process and procedures so that the quality of the product may be regulated.
Keywords: Process Validation, Process Validation Stages, Validation master plan, protocol, quality control.