Prospective Process Validation of Vitamin-E 200 (Alpha Tocopherol Acetate BP 200 Mg) Capsule

Authors: Shome M*

DOI: 10.23880/nnoa-16000330

Volume 9, Issue 4

Abstract

Process validation is a documented evidence which provides a high degree of assurance that a specific process will consistently produce a result meeting its predetermined specifications and quality attributes. Validation is documented act of proving that any procedure, process or system that actually leads to a expected result. The purpose of this investigation is to study prospective process validation of Vitamin-E 200 (Alpha Tocopherol Acetate BP 200 mg) capsule. Quality cannot be adequately assured by in-process inspections and testing but it should be built into the manufacturing process. This process should be controlled in order that the finished product meets all quality specifications. Therefore, building of quality requires careful attention to a number of factors, such as the selection of materials, product and process design, control variables in-process inspection. The critical process parameters were identified with the help of process capability and evaluated by challenging its lower and upper release specifications. Three initial process validation batches of same batch size, method, equipment, & validation criteria were taken. The critical parameters involved in dispensing, mixing (preparation of bulk solution), band solution preparation, encapsulation and band sealing stages were identified and evaluated as per validation plan. The outcome indicates that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes which is in compliance with the GMP.

Keywords: Prospective Process Validation; Control Variables; In-Process Control

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