Research Article Patil et al., 10(9-10): Sep/Oct, 2019:6364-6384] CODEN (USA): IJPLCP ISSN: 0976-7126 © Sakun Publishing House (SPH): IJPLS 6364 INTERNATIONALJOURNALOFPHARMACY&LIFESCIENCES (Int. J. of Pharm. Life Sci.) Process Validation for Famciclovir Vishal Patil*, Deepak Kumar Gupta, Raju Choukse and Rakesh Patel School of Pharmacy, Dr. APJ Abdul Kalam University, Indore (M.P.) - India Abstract The project entitled "Process validation of Famciclovir 500 mg Tablets" was carried out at Macleods Pharmaceuticals as the validation batch met the specification of tablets. Process validation study on three consecutive batches, Batch No. A, B,and C of Famciclovir 500 mg. Tablets having batch size of 112500 tablets was successfully completed and the manufacturing critical process parameters were validated of this transferred product to show that the process was under control. The study includes the validation of critical steps of manufacturing such as blending, compression, coating and container packing. It shall also establish the suitability of equipments and area used for the production. The process of manufacturing was carried as per the approved batch manufacturing card. The all process validation batches had been manufactured and validated in full compliance with cGMP requirement. Key-words: Process validation, Famciclovir, GMPs. Introduction -"Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre determined specifications and quality characteristics." [1] Conducting process validation is not only a regulatory requirement, but also makes a great deal of sense from engineering as well as a business point of view. It is evident that pharmaceutical companies that are well versed in conducting process validation have a competitive advantage over those who are not. Process validation is required, in both general and specific terms, by the Current Good Manufacturing Practices regulations for finished pharmaceuticals, 21 CFR parts 210 and 211. A requirement for process validation is set forth in general terms in sections 211.100 written procedures; deviations-which states, in parts; "there shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality and purity; they purport or are represented to posses". Several sections of cGMP regulations states, validation requirement in more specific terms. Excerpts from some of the sections are: Section 211.100 sampling and testing of in process materials and drug products. * Corresponding Author E.mail: cemoon06@gmail.com a) "Control procedures shall be established to monitor the output and validate the performance of those manufacturing process that may be responsible for causing variability in the characteristics of in process material and drug products." Section 211.113 control of microbiological contamination b) "Appropriate written procedures, design to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of any sterilization process." The requirement of process validation is implicit in the language of schedule M, Good manufacturing practices regulation which states "To achieve the objective, each licensee shall evolve methodology and procedure which should be documented and kept for reference and inspection". Process validation is required by the medical device GMP regulation, 21 CFR parts 820. Section 820.5 requires every finished device manufacturer to states: "Prepared and implement a quality assurance program that is appropriate to the specific device manufactured". Section 820.3 states: "All activities necessary to verify confidence in the quality of the process used to manufacture a finished device". A generally stated requirement for process validation is contained in section 820.100, states: "Written manufacturing specification and processing procedure shall be established, implemented, and controlled to assure that device conforms to its original design or any approved changes in that design". Validation is an essential element in the