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Quality assertiveness by industrial process validation program of superliv ds premix formulation

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

The axial aim of this study is to create a valuable Risk Management Approach that enables a Process Validation over products lifecycle. Quality risk management has been described in regulatory guidance for several aspects of process validation, such as product lifecycle, extent of validation, determination of critical quality attributes, critical process parameters, process design space, sampling plans and statistical confidence levels. Verification of the process in every single produced batch over the product life time is now an expectation from regulatory authorities. In accordance to this Ayurvet Limited has compulsory adopted Process Validation as collection and evaluation of data, from the process design phase, commercial production phase, establishing scientific evidence that a process is in state of control and therefore capable of consistently and effectively assure product quality. Since Herbal formulations and processes are complex and multivariate by nature, a scientific understanding of relevant multi-factorial relationships requires risk-based approach. In this context, planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, are formally documented and the impact on the validated status or control strategy assessed. Validation study inevitably leads to process optimization, better productivity and lower manufacturing cost. It is implicit that a robust product development process is in place to enable successful process validation. The aim was successfully achieved on Superliv DS Premix formulation, and a systematic approach that enables process validation study for the assessment, control, communication and review of risks, targeting the highest quality of herbal formulations is now available to be applied - Ayurvet Limited Process Validation Program.

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