The British Pharmacopoeial Commission is requesting comment from OINDP manufacturers regarding proposed changes to its inhaled product monographs. The BP has posted a draft document authored by its Inhaled Products Working Party and has asked that manufacturers of MDIs, DPIs, and nebulizer solutions submit comments along with any relevant data.
The draft document introduction makes several recommendations, in large part related to the alignment of the BP “Preparations for Inhalation of the British Pharmacopoeia” general monograph and individual inhalation product monographs with the Ph. Eur. “Preparations for Inhalation” general monograph (0671). The working party also suggests that, “The BP Commission should advocate to the Ph. Eur. Commission that a general monograph providing information for the testing of spacers, holding chambers and facemasks should be developed through the Pharmacopoeial Discussion Group (PDG) harmonization process.”
Furthermore, the document notes that once the BP has aligned its requirements with the Ph. Eur. “Preparations for Inhalation” general monograph in 2014, the BP general monograph will be obsolete. Therefore, the working party suggests omitting that monograph from the BP from 2015 on.
Companies wishing to comment on the proposed changes should submit their information to the Secretariat (bpcom@mhra.gsi.gov.uk) using the official response form.
View the draft document.
