Monograph development

The BP Secretariat prepares monographs by working with:

  • market authorisation holders (MAHs)
  • other pharmacopoeias
  • the BP Commission (BPC) and its expert advisory groups (EAGs), panels of experts and working parties
  • the BP Laboratory
  • interested parties

Contribute to monograph development

Send the following information to bpcom@mhra.gov.uk to develop a new monograph, or propose a revision to a published monograph. The Common Technical Document (CTD) equivalents are given in brackets.

  • definition/characteristics (3.2.P.1)
  • licensed finished product specification (3.2.P.5.1 & 6)
  • methods (3.2.P.5.2), supporting validation data (3.2.P.5.3) and batch data (3.2.P.5.4) for:
    • identification
    • dissolution
    • related substances
    • assay
    • any other tests as necessary
  • names and structures of known synthetic impurities and degradants (3.2.P.5.5)
  • product stability information (3.2.P.8.3)

Send the following materials with Material Safety Data Sheets and Certificates of Analysis to the
Materials Management team at the BP Laboratory, Queen's Road, Teddington, Middlesex TW11 0LY:

  • finished product – 100 units per strength or 100 mL per strength
  • API – 100 g
  • associated impurities – 25 g

Refer to supplementary chapter III of the BP for more guidance.

Information provided will be kept confidential to the BP Secretariat and Laboratory and to the
relevant BPC EAGs.