Express Pharma

Quality by Design: Step-by-step Implementation for Formulation Development

Ranjit Barshikar QbD/cGMP Consultant & Member of Editorial Board, Journal of Generic Medicines

Ranjit Barshikar, QbD/ cGMP Consultant & Member of Editorial Board, Journal of Generic Medicines, England gave a comprehensive presentation on the steps to implement Quality by Design in formulations. He detailed the importance and role of QbD in formulation development and drug delivery to ensure better product quality and thereby patient compliance. His session emphasised on not just quality by testing (QbT) of the final product but also quality by design (QbD) of the process, including sourcing input ingredients of the desired quality.

He listed down six steps as a QbD road map for formulation development. The first step was creating a quality target product profile to define quality attributes, prerequisites to deliver therapeutic benefit as per label claims.

The second step is to identify Critical Quality Attributes (CQA) and determine the physical, chemical, biological, or microbiological property or characteristic that should be within appropriate limit to ensure desired product or raw material quality. The third step involves ranking critical process parameters and adopting them effectively to get the right impact in case of critical quality attributes. It requires initial risk assessment of the formulation variables justification to develop an effective control strategy.

The next step is marking the design space in a way that it leaves room for innovation and at the same time provides meaningful regulatory flexibility. The fifth step is devising an effective control strategy to ensure process performance and product quality. The last one in Barshikar’s list is life cycle management.

Barshikar also elaborated on USFDA requirements and the role of QbD in easing regulatory compliance. He ended his session by reiterating that QbD is about delivering a high quality product that meets customer’s need.

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