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UK MHRA Consults On Applying Quality By Design Principles To Monographs

 
• By Vibha Sharma

The proposal by the UK regulator builds on a case study which showed that AQbD processes can add value to pharmacopoeial method development.

aluminum tanks for the storage of raw materials in the chemical industry, sterile conditions in the enterprise
Applying The AQbD Concept Can Assure Medicines Quality • Source: Shutterstock

The UK Medicines and Healthcare products Regulatory Agency is inviting stakeholder feedback on its proposal to apply analytical quality by design (AQbD) principles to pharmacopoeial standards. The agency believes that the adoption of AQbD principles would offer "clear added benefits" and lead to a "more robust, and clear framework than that which currently exists" in the British Pharmacopoeia.

The consultation document – on which comments will be accepted until 31 August – includes a series of examples...

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