Quality by design: A systematic approach to pharmaceutical development


By Mayank Nagar, Kamal Singh Panwar, V. S. Chopra, Indu Bala



The use of QbD principles during product development provides opportunities to facilitate innovation and continual improvement throughout the product lifecycle, compared to traditional approaches hence it is systematic way to product and process development. QbD principles increase process knowledge and product understanding, often through the application of new technologies such as PAT or modeling. The increased process knowledge and product understanding resulting from QbD can increase the efficiency of manufacturing processes; reduce product recalls and compliance actions, resulting in cost savings for pharmaceutical companies. By reducing uncertainty and risk, QbD can allow industry and regulators to focus their resources in the most critical areas. Because much more process understanding has been demonstrated and expressed in the dossier, QbD filings also can help facilitate CMC reviews and GMP inspections by the regulators and decrease the number of post-approval regulatory submissions required to make process changes. QbD can also facilitate the use of innovative technologies and promote the use of new approaches to perform process validation, such as continuous quality verification.

Key Words : Quality by design (QbD), continual improvement, process analytical technique (PAT), chemical manufacturing and control (CMC), good manufacturing properties (GMP), validation.

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