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Strategy for pharmacopoeial public quality standards for biological medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the important role that biological medicines have in protecting public health and has developed a Strategy for pharmacopoeial…
Uploaded: 14 July, 2023
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 …
Uploaded: 14 July, 2023
Application of Analytical Quality by Design concepts to pharmacopoeial standards for medicines
In June 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) published a consultation to understand the views of stakeholders on the application of Analytical Quality by Design (AQbD)…
Uploaded: 14 July, 2023
Guidance on the application of flow cytometry for the cell and gene therapy community
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…
Uploaded: 14 July, 2023
Guidance on the application of vector copy number quantification for the ATMP community
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…
Uploaded: 14 July, 2023
Change proposals 2020: LC/UV-DAD, LC-PAD and expression of related substances limits
In July 2020, the BP reached out to Users to consult on change proposals. Since the consultations closed in September 2020, we have worked to review all the comments and made recommendations to the re…
Uploaded: 14 July, 2023
Guidance on the Characterisation of the particle population in AAV products
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…
Uploaded: 14 July, 2023
Guidance on T cell and NK cell characterisation assays
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…
Uploaded: 14 July, 2023
New and revised draft texts available for comment
As part of our ongoing work to ensure that content within the BP is up-to-date and relevant, we routinely upload new and revised draft texts for public consultation and feedback. It is important to us…
Uploaded: 5 July, 2023
New Members sought for the British Pharmacopoeia Commission
The British Pharmacopoeia Commission is currently looking to appoint up to 6 new members with effect from 1st January 2024. This includes both professional members and lay members. For the professiona…
Uploaded: 5 July, 2023