Pharmaceutical Product Development: Quality by Design (QbD)

Chintu Valeru

doi:10.37022/jpmhs.v7i3.115

Authors

Valeru Chintu Priyadarshini Institute of Pharmaceutical Education and Research, 5th Mile, Pulladigunta, Guntur-522017.Andhra Pradesh, India.

DOI:

https://doi.org/10.37022/jpmhs.v7i3.115

Keywords:

Quality by Design (QbD), ICH Guidelines, Target Product Quality Profile (TPQP), Critical Quality Attribute (CQA), Critical Process Parameter (CPP), Quality Risk Management (QRM)

Abstract

A popular modern strategy in pharmaceutical development is called "quality by design," or QBD, which started with established goals including the product's safety and efficacy. Safety and product efficacy are the primary goals of QBD in pharmaceutical development. With QBD, the design itself is emphasized for excellence. QBD was introduced by the Food and Drug Administration in order to comprehend the production process. An overview of the pharmaceutical quality system, quality risk management, and international council for harmonization (ICH) rules for product development is provided in this article in order to preserve product quality. The scientific foundation of QBD, regulatory industry perspectives, and QBD technologies were briefly discussed. There was a focus on excipients, manufacturing process development, container closure systems, and pharmacological substances. The Q9 guidelines for quality risk management, Q10 guidelines for pharmaceutical quality systems, and Q8 guidelines for pharmaceutical development form its basis. In the research and production of pharmaceuticals, it also provides an application of Quality by Design.

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