MHRA Seeks Comments Analytical Quality by Design
The UK’s Medicines and Healthcare products Regulatory Agency is inviting comments by Aug. 31 on the application of analytical quality by design (QbD) principles.
The agency defines analytical QbD as a systematic approach to development that emphasizes “product and process understanding and process control, based on sound science and quality risk management.”
The consultation is intended to gather feedback on the agency’s application of analytical QbD concepts. The document includes examples of potential models for inclusion in the MHRA’s drugmaking standards.