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...