The ADL Conclave 2022 also saw a panel discussion on the topic “Best practices in analytical QbD.” The panellists in the session involved Dr Ranjit Barshikar, CEO, QbD International; United Nations Adviser – Geneva (Moderator); Dr Sujay Rajhans, President and Head – R&D, JB Chemicals and Pharmaceuticals; Dr Sandeep Zokande, VP – Analytical, Indoco Remedies; Dr Amarnath Chatterjee, Sr Lead Investigator and Head – Analytical Development Biologics, Syngene International and Dr Shakil Sait, Associate VP – Analytical Development (API & Formulation), USV.
Dr Barshikar, while beginning the session, said that Quality by Design (QbD) is not new to the world. It is over seven-eight decades ago that this has been introduced, but pharma industry is way behind in implementing this concept. In the last one decade though, things have taken speed in terms of implementation, especially on the product development for the QbD elements’ implementation to ensure robust process, product development and minimise the failures and rejections (if any), and to increase the consistency in manufacturing batch after batch. He further mentioned other benefits of QbD, while taking the panel discussion forward.
During the discussion, Dr Rajhans gave information on the USP moving ahead into QbD for the industry purpose. Dr Sait said that there is lack of experience or knowledge on the drug substance and drug product, lack of knowledge in the physicochemical properties, improper screening of different phases through different lot, inadequate screening of mobile phase, etc. “aQbD is a systematic approach where we cover all the issues faced in the traditional approach. There, we define an Analytical Target Profile (ATP), where we design screening method based on scientific knowledge and experience establishing critical quality attributes, method optimisation using DoE for multi-variant factors, and then coming to method validation. aQbD helps us to have a robust, rugged and quality analytical method. It takes care of the lifecycle management and gains an ongoing assurance and ensure that the method remains in the state of control during entire routine use.”
Dr Chatterjee also shared his views with the audience on USP introducing general notices on analytical QbD, specifically with regard to the biological products.
Dr Zokande informed that the pharmacopoeia standards are designed based on the available information at the time of setting those standards, and are based on the regulatory requirements. “When we apply the pharmacopeia standards for our generic formulation or generic drugs, those standards may not be suitable as it is. We try to use the pharmacopeia standards, but when those are not suitable, we are designing some type of justification which means that our methodology is superior than pharmacopeial standards. So, aQbD is one such approach which is designed based on the science.”
The panellists also talked about recruiting people and training them in the process of aQbD, among several other topics of importance.
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