Monograph development
The British Pharmacopoeia will consider elaboration of a monograph in the British Pharmacopoeia if it adheres to the criteria in BP Supplementary Chapter III B. Monograph Development Mechanism.
Participation in monograph development is welcomed
Manufacturers are encouraged to get involved. Manufacturers who wish to participate in the preparation of a monograph for the British Pharmacopoeia that has recently been initiated can do so by:
- Submitting a new draft monograph with supporting validation data;
- Submitting proposals for appropriate standards and analytical procedures together with validation data.
Summary Guidance
Data required
General guidance as to the types of test required and the level of control considered appropriate can be obtained by reference to current BP monographs for similar chemical entities or products where such are available. Further information is given in BP Supplementary Chapter III C. Monograph Development: Guidance to Manufacturers. In general any monograph for a drug substance or product should include the features listed below:
General guidance as to the types of test required and the level of control considered appropriate can be obtained by reference to current BP monographs for similar chemical entities or products where such are available. Further information is given in BP Supplementary Chapter III C. Monograph Development: Guidance to Manufacturers. In general any monograph for a drug substance or product should include the features listed below:
Licensed finished product specification
Definition/Characteristics
Solubility
Identification
Tests (including but not limited to):
- Related substances and limits for impurities;
- Dissolution (where necessary);
- Uniformity of content (where necessary);
- Assay;
- Any other tests as necessary.
Product stability information
Storage
Labelling
Appropriate and relevant validation data relating to the proposed analytical procedures and methodology should be provided (see Supplementary Chapter III F. Validation of Analytical Procedures). In particular, data to demonstrate the stability-indicating nature of methods (i.e. forced degradation studies) and information identifying both synthetic impurities and degradation products should be provided. Additionally, appropriate and relevant batch and stability data to support the proposed specifications should be provided.
Confidentiality
Information provided will be kept confidential to the BP Secretariat and Laboratory and to the relevant Expert Advisory Group(s) of the British Pharmacopoeia Commission.
Information provided will be kept confidential to the BP Secretariat and Laboratory and to the relevant Expert Advisory Group(s) of the British Pharmacopoeia Commission.
Samples
The BP Laboratory will check to ensure that the methods are suitable as Pharmacopoeial tests. A quantity of the material sufficient to carry out in duplicate all the tests and the assay in the proposed specification should be supplied (minimum 100 units per strength). This sample should be taken from a typical production batch, that is, it should not be specially prepared. In addition appropriate amounts of possible impurities should be supplied (0.1 to 0.5 g is usually suitable).
The BP Laboratory will check to ensure that the methods are suitable as Pharmacopoeial tests. A quantity of the material sufficient to carry out in duplicate all the tests and the assay in the proposed specification should be supplied (minimum 100 units per strength). This sample should be taken from a typical production batch, that is, it should not be specially prepared. In addition appropriate amounts of possible impurities should be supplied (0.1 to 0.5 g is usually suitable).
Many monographs require the use of one or more reference substances (BPCRS); these are established by the Laboratory before publication of the monograph (see Supplementary Chapter III E. British Pharmacopoeia Chemical Reference Substances).
If a reference substance for assay purposes or for impurity control is required, please indicate if adequate supplies will be available. About 50 g of material is required to establish a reference material for an assay standard and about 10 g of a named impurity. If it is perceived that an ongoing supply of sufficient quantities of material(s) will not be possible, this should be drawn to the attention of the BP Secretariat so that an alternative approach may be considered.
When sending samples, material safety data sheets that comply with COSHH Regulations should be supplied for all materials including impurities, so that Pharmacopoeia staff are aware of possible hazards when handling these materials.
Submission Guidelines
Data packages
Electronic submission of data packages is preferred. Submit data packages by the following routes:
Electronic submission of data packages is preferred. Submit data packages by the following routes:
Online: via the Monograph Initiation Request Form.
Email: BPmonographs@mhra.gsi.gov.uk
Post: Monograph Initiation Secretariat
British Pharmacopoeia Commission
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
Vauxhall
London
SW8 5NQ
Checklist
All data packages sent by email or post should be returned with a reply form and checklist.
All data packages sent by email or post should be returned with a reply form and checklist.
Samples
Send all samples with material safety data sheets to:
Send all samples with material safety data sheets to:
Monograph Initiation Samples
British Pharmacopoeia Commission Laboratory
Queen’s Road
Teddington
Middlesex
TW11 0LY
When samples have been sent please email BPmonographs@mhra.gsi.gov.uk to inform the British Pharmacopoeia Commission Laboratory to expect samples.
The associated pages of information provides guidance on the status of new monographs that are being drafted and monographs which are undergoing revision.
Explanation of status
Initiated – the development of this monograph has been initiated but work has not yet started. At this stage manufacturers may submit proposals for appropriate standards with supporting data. For more information see the Monograph Initiation page.
In progress – work on this new monograph is in progress following submission of data by manufacturers. For more information see the Draft Monographs page.
Revision – work is in progress in revising this published monograph following request by a manufacturer, changes to the relevent drug substance monograph or request by the BP Commission's Expert Advisors. For more information see the Draft Monographs page.
Finalised - work on this monograph is complete and will be published in a forthcoming edition of the British Pharmacopoeia.