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Quality assurance by effective manufacturing process validation of bovituss liquid a polyherbal formulation

Author: 
Kotagiri Ravikanth, Anirudh Sharma and Deepak Thakur
Subject Area: 
Life Sciences
Abstract: 

Formulations must be manufactured to the highest quality levels. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. It is an essential regulatory requirement. According to Food and Drug Administration (FDA), the goal of validation is “To Establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes.” Process validation is to create robust manufacturing process that consistently produces a drug product with minimum variation that adheres to quality criteria of purity, identity and potency. In the last few decades there has been an exponential growth in the field of herbal medicine. It is getting popularized in developing as well as in developed countries owing to its natural origin and lesser side effects. Herbal medicines are being manufactured on the large scale in Pharmaceutical units, where manufacturers come across many problems such as availability of good quality raw material, authentication of raw material, availability of standards, proper standardization methodology of single drugs and formulation, quality control parameters. Therefore, at present quality assurance is one of the thrust area for the evaluation of traditionally vv used medicinal plants and herbal formulations. Phytochemical constituents present in the polyherbal formulation act as the critical quality attributes and control variables which are essential to carry out the process validation. Development of authentic analytical methods which can reliably profile the phytochemical composition and help in validation of manufacturing process is a major challenge to scientists. Thus control of the process from the beginning to the end and quality assurance along the complete process chain is the key which will ensure the batch to batch consistency of finished polyherbal products. Results proved that manufacturing process stands validated as it met acceptance criteria.

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