BP Consultations

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. 

Change proposals 2020: LC/UV-DAD, LC-PAD and expression of related substances limits

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. 

Guidance on the application of vector copy number quantification for the ATMP community

British Pharmacopoeia consultation on non-mandatory, best practice guidance for standardising the application of vector copy number quantification. 

Guidance on the application of flow cytometry for the cell and gene therapy community

British Pharmacopoeia consultation on authoritative, non-mandatory, best practice guidance for standardising the application of flow cytometry. This consultation closed on 19 May 2021.

Proposed Supplementary Chapter for BP 2022 – The application of Analytical Quality by Design to pharmacopoeial methods

Stakeholders are invited to comment on the draft supplementary chapter for the application of analytical quality by design to pharmacopoeial methods. This consultation closed on 2 May 2021.

Application of Analytical Quality by Design concepts to pharmacopoeial standards for medicines

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.

Strategy for pharmacopoeial public quality standards for biological medicines 

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. 

Dissolution

The British Pharmacopoeia developed a strategy, through public consultation, to improve dissolution testing requirements and guidance for solid oral dosage forms.

Inhaled products

The British Pharmacopoeia developed revised requirements for inhaled product monographs, through public consultation.