Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authrs: Vishawas Sinha, Kamlesh Pratap

Abstract: Quality by design (QbD) is the modern method to ensuring pharmaceutical safety and efficacy. This review describes quality by design and identifies some of its features to assure pharmaceutical quality. Each unit operation's process parameters and quality characteristics are identified. This article discusses the advantages, opportunities, and procedures involved in pharmaceutical product quality through design. The ICH quality recommendations Q8, Q9, and Q10 for pharmaceutical development, quality risk management, and pharmaceutical quality systems, respectively, provide examples of how to use quality by design in pharmaceutical development and manufacture.The goal of pharmaceutical development is to create a high-quality product and manufacturing method that consistently delivers the product's expected performance. Throughout the product's development, steps should be done to add to or improve its quality. It contains the Quality goal product profile, vital quality attributes, and other important Quality by Design features. QbD also compares the quality of a product based on end-product testing to the quality of a product based on quality by design. Quality by Design is a concept that was described and presented in an international conference for harmonisation.

Keywords: Critical quality attributes, critical material attributes, critical process parameters, international conference for harmonization, quality by design, quality target product profile