Pharma Quality by Design (QbD)

Creating the Organisational Strategy Map
through a participative workshop

Pharma Quality by Design (QbD)

Quality begins and ends with the customer. QbD is a concept first developed by quality guru Dr. Joseph M. Juran. Dr. Juran believed that quality should be designed into the product, and that most quality issues relate to the product design. The objective of Quality by Design (QbD) therefore is to build quality into the product thus reducing reliance on inspection to assure quality. Pharma Quality by Design (QbD) ensures safe and effective drug delivery to the consumer, and also offers the promise to significantly improve manufacturing process robustness.

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What We Do

The QbD approach stands in contrast to traditional approach of quality through inspection prevalent in the Pharma industry. SSA has been a vanguard for QbD adoption in India and its neighbouring region. SSA’s QbD deployment approach recognises the need for quality that transcends all stages of drug development from concept tocommercialisation. Our two-pronged approach of knowledge transfer through training and skill building through coaching ensures that QbD culture takes root in the organisation. With prestigious clients such as Sun Pharma, Astra Zeneca and Lupin to boast of, SSA’s QbD training material and consulting solutions sets the gold standard.

How We Help Clients

Our highly skilled and experienced consultants work closely with clients helping them negotiate the nuances of the QbD journey. Our approach involves helping clients carefully prioritise and select critical quality attributes, perform quality risk assessment and undertake design of experiment studies to statistically establish influencing factors. The end objective is to develop a viable design space and control strategy that ensures robust product and process quality throughout the product lifecycle.

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