Consultation for Vector Copy Number guidance revision and addition of Polymerase Chain Reaction validation annexes
The British Pharmacopoeia (BP) has prepared a draft update to the guidance for Vector Copy Number, which includes a revision to the guidance itself as well as new Polymerase Chain Reaction validation plans. This update, written by experts, will be helpful to a range of stakeholders including those in GMP regulated environments, research and development, academia, and clinical trials.
We would like your feedback on the guidance and validation plans from an individual standpoint as well as from your organisation’s standpoint – whichever is more appropriate. Your feedback will be used to improve the documents prior to their formal publication.
The consultation document, including background and the update can be found here.
Download the consultation document.
The response form can be found here.
Download the consultation response form.
Completed response forms should be returned to BiolStandards@mhra.gov.uk by 19 March 2025.