Supplementary Chapter on the use of Analytical Quality by Design concepts for analytical procedures

A public consultation on this supplementary chapter closed on 2 May 2021. Stakeholder comments were gratefully received and considered by the BP team and its expert working party. As a result, the Supplementary Chapter on the use of Analytical Quality by Design concepts for analytical procedures (Supplementary Chapter X) was published in the BP 2022.

The chapter is not mandatory and is provided as guidance for the application of Analytical Quality by Design principles to pharmacopoeial procedures and across the entire analytical method lifecycle. It is intended that the British Pharmacopoeia, together with its expert working party, will add to and revise this guidance as internal and external knowledge grows and further international standards are developed.

If you have any queries on the chapter, please email the usual BP query mailbox, BPCOM@mhra.gov.uk, and our team will get back to you.

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Application of Analytical Quality by Design to Pharmacopoeial Methods