The British Pharmacopoeia 2023 marks a significant update, superseding the previous 2022 edition. It has been meticulously compiled by the British Pharmacopoeia Commission, with extensive contributions from its Expert Advisory Groups, Panels of Experts, and Working Parties. This edition includes approximately 4,000 monographs, providing detailed specifications for substances, preparations, and articles essential to the practice of medicine.
Monographs and Their Origins
The monographs in the British Pharmacopoeia serve as authoritative standards. Some of these are of national origin, developed or revised under the direction of the British Pharmacopoeia Commission. Others, denoted by a chaplet of stars, originate from the European Pharmacopoeia Commission. These latter monographs have been developed or updated with input from the European Pharmacopoeia’s own Groups of Experts and Working Parties and are reproduced in the British Pharmacopoeia to ensure comprehensive standards.
Integration with the European Pharmacopoeia
The 2023 edition, along with the British Pharmacopoeia (Veterinary) 2023, incorporates all monographs from the 10th Edition of the European Pharmacopoeia, including amendments up to Supplements 10.1 and 10.8. This integration ensures that users of the British Pharmacopoeia have access to the most current pharmacopoeial standards across the UK for both human and veterinary medicines.
The BP 2023 complete package
- Six-volume printed edition, including the BP (Veterinary) 2023
- Single-user online licence
- Single-user download for offline use
BP 2023
Available from 1 August 2022 | Effective from 1 January 2023 | Superseding the BP 2022.
The British Pharmacopoeia (BP) 2021 is the most comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products. It includes around 4,000 monographs including the BP (Veterinary) and all European Pharmacopoeia (Ph. Eur.) monographs, making the BP a convenient and fully comprehensive set of standards that can be used across Europe and beyond.
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Why use the BP?
If a pharmaceutical substance or finished product is marketed in a country where the BP is a legal standard, it must comply with the requirements of the BP throughout its shelf life.
The BP is a vital reference tool for all individuals and organisations involved in pharmaceutical:
- research & development
- manufacture
- quality control and analysis
Usage and Application of General Notices
The British Pharmacopoeia follows distinct guidelines depending on the source of the monograph. When a monograph is reproduced from the European Pharmacopoeia, the methods, tests, or other matters referenced in the appendix adhere to Part III of the General Notices. For all other monographs, Part II of the General Notices applies.
What does the BP contain?
The BP includes:
- general notices (providing general information applicable to all texts)
- general monographs (apply to all dosage forms)
- specific monographs providing mandatory standards for:
- active pharmaceutical ingredients
- excipients
- formulated preparations (licensed and unlicensed products)
- herbal drugs, herbal drug products and herbal medicinal products
- materials for use in the manufacture of homoeopathic preparations
- blood-related products
- immunological products
- radiopharmaceutical preparations
- infrared reference spectra
- appendices
- supplementary chapters (providing additional guidance)
- comprehensive index
British Pharmacopoeia (Veterinary)
The BP (Veterinary) is published as a companion volume to the British Pharmacopoeia. It contains standards for substances and products used solely in the practice of veterinary medicine in the UK.
The BP (Vet) also incorporates monographs and texts of the European Pharmacopoeia.
What's included?
In addition to all European Pharmacopoeia and BP Veterinary texts being included, the new BP 2023 edition also features:
Monographs and BPCRS:
- 23 new BP monographs, 59 new Ph. Eur. monographs.
- 151 amended BP monographs.
- All monographs from the Ph. Eur. 10th edition as amended by supplements 10.1 to 10.8 are included.
- The Ph. Eur. 11th edition, as amended by supplements 11.1 and 11.2 are included as in-year online and download product updates.
- Updates to BPCRS coincide with BP 2023 to ensure that you remain compliant.
Supporting content:
New Analytical Quality by Design (AQbD) guidance for selected monographs ensures patient safety by providing an outline of best practices to ensure product quality is upheld throughout the product’s lifecycle.
The Advanced Therapy Medicinal Products (ATMP) Flow Cytometry and Vector Copy Number best practice guidance texts offer a practical and phase appropriate validation tool to help your cell therapy programme succeed.
A new Supplementary Chapter for Inactivated Veterinary Autogenous Vaccines.
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