Vinodh Kumar S Mannur
KLE College of Pharmacy, India
Title: Challenges in Implementing Quality By Design (QbD) in the development of herbal products
Biography
Biography: Vinodh Kumar S Mannur
Abstract
A review of the regulatory status of herbal drugs/products was done for few countries. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. Quality by design is a crucial part of the modern approach to pharmaceutical quality. “Quality could be planned and most of quality deficit arises in the way process is planned and developed”, this thought of well-known quality expert Joseph Moses Juran gives foundation to the concept of quality by design (QbD). It refers to a new approach to product development that could increase efficiencies, provide regulatory relief and flexibility. Recently, the US Food and Drug Administration introduced quality by design (QbD) as a fundamental pharmaceutical quality model to be considered in the process and product development of pharmaceuticals. QbD concept has been supported by International Conference on Harmonisation (ICH) guidelines Q8 (R2). The beneficial impact of herbs on human health have been used for centuries and widely accepted by patients to the present day. The efï¬cacy of herbal drugs often results from a complex composition of substances. The complexity of herbal drugs is the major reason for the lack of satisfactory studies into their effect and causes problems for the deï¬nition and assurance of quality. The implementation of QbD enables robust manufacturing process, and facilitate product quality. Herbs have in general a broad variety of compounds depending on growth and harvesting conditions. A suitable process design rated by the QbD principals can ensures a robust process from extraction to puriï¬cation of herbal drugs in spite of their complex nature. Quality by Design is a powerful development approach that offers a number of technical, quality, and regulatory dividends. Hence application of quality by design (QbD) for development of herbal drugs can give rise to improved understanding of process which in turn will facilitate proper identification of sources of variation, management of variability by process design, and prediction of product quality attributes.