Contribute to monograph development and improvement

You may ask the British Pharmacopoeia Commission to develop a new monograph or propose a revision to an existing one by following the steps below.

You may want to propose a revision to an existing monograph to update or improve a published method for any number of reasons: For example, if a reagent is no longer readily available, to achieve greater efficiency, or to reduce adverse environmental effects.

For example, scaling methods can help to reduce environmental impact. Appendix III Chromatographic Separation Techniques (Ph. Eur. method 2.2.46) outlines permitted adjustments that can be made to scale down a method, without the need for re-validation. We encourage users to send information to support revisions that adopt these permitted adjustments

Send the following information to 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, LGC, 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
  • placebo - 10 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.

Alternatively you can provide your feed back on existing draft texts via the dedicated consultation page. Within your draft texts of interest there will be specific instructions on how to submit your comments for that text.


Common Technical Document

Helpful Links

Contribute to draft texts