British Pharmacopoeia 2023

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.

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

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.

European Pharmacopoeia

The Ph. Eur. is published by the European Directorate for the Quality of Medicines & HealthCare.

The European Pharmacopoeia Commission is responsible for the publication of the Ph. Eur. The UK is a member of the EP Commission and is involved at all stages of Ph. Eur. monograph development.

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.

Post a Comment


Table of Contents