Abstract

QUALITY ASSERTIVENESS BY PROSPECTIVE PROCESS VALIDATION OF TOXIROAK GOLD PREMIX A POLYHERBAL FORMULATION

Kotagiri Ravikanth, *Thakur Deepak, Sharma Anirudh, Chauhan Abhinay, Sadana Lokesh and Sapra Sameer

Abstract

Validation study first proposed by Food and Drug Administration (FDA) and is a concept that is fundamental to Good Manufacturing Practice (GMP) and any quality assurance program. Validation of the individual steps of the process is called process validation. It is necessary for the efficient use of the resources. The study incontrovertibly leads to an objective of process optimization, better productivity and lower manufacturing cost. Validation concept is somewhat less implemented in herbal industries. It is necessary to development of modern and objective standards for evaluating quality of herbal medicines. So there is an urgent need of process validation in manufacturing of herbal drugs to improvise the quality of herbal drugs. Phytochemical constituents present in the polyherbal formulation act as critical quality attributes and control variables which are essential to carry out the process validation. As per ICH Q8 guidelines of pharmaceutical development a critical quality attribute is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. 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.

Keywords: Process Validation, HPLC, Rutin, Toxiroak Gold premix.