British Pharmacopoeia (BP) 2017

The British Pharmacopoeia (BP) is the official publication that contains a comprehensive collection of standards and guidelines for medicinal products and pharmaceutical substances used in the United Kingdom. The BP is recognized worldwide as one of the leading authorities in pharmaceutical standards, and the latest edition, British Pharmacopoeia 2017, continues this tradition of excellence.

The British Pharmacopoeia 2017 provides a set of quality standards and specifications for medicines used in the UK, and these standards are also used in many other countries. The publication includes monographs, which provide detailed information on individual pharmaceutical substances, and general chapters that provide guidance on various aspects of pharmaceutical manufacturing and quality control.

One of the key features of the British Pharmacopoeia 2017 is its focus on ensuring that medicines meet high standards of quality, safety, and efficacy. The publication contains a range of tests and assays that can be used to assess the quality of pharmaceutical substances, and it provides guidance on how to conduct these tests and interpret the results.

Another important aspect of the British Pharmacopoeia 2017 is its emphasis on ensuring that medicines are manufactured in a way that is consistent with good manufacturing practices. The publication provides guidance on various aspects of pharmaceutical manufacturing, such as facility design, equipment qualification, and process validation.

Overall, the British Pharmacopoeia 2017 is an essential reference for anyone involved in the manufacture, testing, or regulation of pharmaceutical products. Its comprehensive collection of standards and guidelines ensures that medicines produced in the UK and beyond meet high standards of quality, safety, and efficacy.

The British Pharmacopoeia (BP) 2017 supersedes the BP 2016 and becomes legally effective on 1 January 2017. This edition incorporates new BP and European Pharmacopoeia monographs and a significant number of revised monographs. Also included are new information for unlicensed medicines and DNA barcoding.

Updated annually, the BP is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products. The BP 2017 includes almost 4,000 monographs which are legally enforced by the Human Medicines Regulations 2012. Where a pharmacopoeial monograph exists, medicinal products sold or supplied in the UK must comply with the relevant monograph. All monographs and requirements of the European Pharmacopoeia are also reproduced in the BP.  

New for 2017:
  • 29 new BP monographs
  • 234 amended monographs
  • Four new formulated preparation monographs for biological medicines
  • Two new monographs for unlicensed formulations
  • A new informally harmonized drug product monograph (Aprepitant Capsules)
  • A new supplementary chapter on DNA barcoding
  • A new supplementary chapter on the Aseptic Preparation of Unlicensed Medicines
  • All European Pharmacopoeia monographs integrated (8th Edition as amended by Supplements 8.1 to 8.8)
  • Three in-year website and offline download updates to harmonize with the European Pharmacopoeia 9th Edition (9.0) and Supplements 9.1 and 9.2.

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