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Validation is a tool of quality assurance which provides confirmation of the quality in equipment systems, manufacturing process, software and testing methods. If each step of production process is validated we can assure that the final product is of best quality. Different dosage forms have different validation protocols. In this study process validation of Sodium Valproate enteric coated tablets of strength 200mg and 500mg was carried out. A common protocol was prepared for both the strengths and two batches of each were taken. In-process monitoring of all the critical processing steps such as dry mixing, granulation, wet milling, drying, dry milling, lubrication, compression and coating was done for this transferred product to show that the process was under control. LOD of dried, milled and lubricated granules were checked and was found within the limit. Assay after lubrication was within the specified limit, indicating blend uniformity. Physical parameters, dissolution, assay, test for related substance and residual ethanol content were performed and results found within the acceptance criteria. Keywords: Process validation, Tablets, Quality, Protocol, Manufacturing process. INTRODUCTION:1-9 The primary objective of any pharmaceutical plant is to manufacture products of requisite attribute and quality consistently, at the lower possible cost. Although validation studies have been conducted in he pharmaceutical industry for a long time, there is an ever-increasing interest in validation owing to their industry’s greater emphasis in recent years on quality assurance and productivity improvement. Validation is a necessary part of a quality assurance program and is fundamental to an efficient production operation. Process valida... ... middle of paper ... ... study department is responsible for performing stability studies and compilation of the results. Quality Assurance: QA is responsible for review and approval of the process validation protocol and report, as well as for managing validation constraints and deviations. It is within the scope of QA to approve and release of the validation batch for further processing and to manage any failure/ deviation/ out of specifications encountered during the progress of process validation. Engineering: Engineering is responsible to ensure that all the individual utilities and equipments are qualified, calibrated and ready for use. HSE: Health, safety and environment is responsible to ensure that appropriate personnel protective equipment are in place. It is responsible to ensure that adequate safety instructions have been given to the personnel involved in handling the product.
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