Research Article Patil et al., 10(9-10): Sep/Oct, 2019:6359-6363] CODEN (USA): IJPLCP ISSN: 0976-7126 © Sakun Publishing House (SPH): IJPLS 6359 INTERNATIONALJOURNALOFPHARMACY&LIFESCIENCES (Int. J. of Pharm. Life Sci.) Validation for Moxifloxacin Tablet Pankaj Patil*, Deepak Kumar Gupta, Raju Choukse and Rakesh Patel School of Pharmacy, Dr. APJ Abdul Kalam University, Indore (M.P.) - India Abstract Quality Assurance includes management of the quality of raw materials, assemblies, products and component, management, production, validation and inspection processes. Validation is action of providing in accordance with principle of GMP, that any procedure, process, equipment, materials activity or system actual leads to expected results". At various stages in a validation/qualification exercise there is need for protocols, documentation, procedure, equipment, specifications and acceptance criteria for test results. The FDA has the authority and responsibility to inspect and evaluate process validation performed by manufactures. The cGMP for validated formulations (drugs) manufacturing required that drug product be produced with a high degree of assurance meeting all the attributes they are intended to process of meeting all the attributes they are intended to process. All the physical parameters of all three batches were found well within the acceptable limits. Key-words: Quality Assurance, Validation, Good Manufacturing Practices & FDA. Introduction "Quality Assurance is defined as the maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production. It is the systematic measurement, comparison, with a standard, monitoring of processes and associated feedback loop that confers error prevention. QA includes principles like, "fit for purpose" and "right first time". Quality Assurance therefore incorporates GMP and other factors". QA includes management of the quality of raw materials, assemblies, products and component, management, production and inspection processes. (Potdar 2006). Process validation (P.V.) may be defined as "a documented programmed which provide a high degree of assurance that a specific process will consistently produce a product meeting its pre- determined specifications and quality attributes." Various regulatory bodies have been various definitions to validation. * Corresponding Author E.mail: cemoon06@gmail.com Some consideration should be exercised when selecting the process validation strategy. Amongst these should be the use of different lots of active raw material and major excipients, batch produced on different shifts, the use of different equipment and facilities dedicated for commercial production, operating range of the critical processes, and a thorough analysis of the process data in case of re- qualification and re-validation, During the processing of the validation batches, extensive sampling and testing should be performed on the product at various stage and should be documented comprehensively. Fig. 1: General Type of Process Validation