The British Pharmacopoeia recognises the value that stakeholders can contribute to the development of standards, which ultimately results in higher quality medicines for patients. This page links to details of ongoing or completed consultations that have supported stakeholder contributions to our broader work.
The quality of a medicine is critical to ensuring its safety and efficacy, and therefore the medicine’s suitability for patients. The use of analytical techniques is a vital component in the assurance of medicines quality.
British Pharmacopoeia (BP) has prepared draft authoritative, non-mandatory, best practice guidance on the Characterisation of the particle population in AAV products.
Here you will find details of important monograph change proposals that we have consulted with Users about. Read more about the background to these proposals, the outcomes and actions we have taken or are planning.
British Pharmacopoeia consultation on non-mandatory, best practice guidance for standardising the application of vector copy number quantification.
British Pharmacopoeia consultation on authoritative, non-mandatory, best practice guidance for standardising the application of flow cytometry. This consultation closed on 19 May 2021.
A public consultation on this supplementary chapter closed on 2 May 2021. The Supplementary Chapter was first published in BP 2022.
Following a practical case study and subsequent public consultation, the Medicines and Healthcare products Regulatory Agency (MHRA) has developed a strategy for the application of Analytical Quality by Design (AQbD) concepts in pharmacopoeial standards.
Read about the Medicines and Healthcare products Regulatory Agency (MHRA) public consultation on its Strategy for pharmacopoeial quality standards for biological medicines and its outcomes.
The British Pharmacopoeia developed a strategy, through public consultation, to improve dissolution testing requirements and guidance for solid oral dosage forms.
The British Pharmacopoeia developed revised requirements for inhaled product monographs, through public consultation.