HOT POST

50/recent/ticker-posts

Header Ads Widget

British Pharmacopoeia 2022

The BP 2022 supersedes the BP 2021 and becomes legally effective on 1 January 2022. This edition incorporates new monographs from both the BP and Ph. Eur. along with a significant number of revised monographs.

British Pharmacopoeia 2022
  • The British Pharmacopoeia Commission has caused this British Pharmacopoeia 2022 to be prepared under regulation 317(I) of the Human Medicines Regulations 2012 and, in accordance with regulation 317(4), the Ministers have arranged for it to be published.
  • The monographs of the Tenth Edition of the European Pharmacopoeia (2019), as amended by Supplements 10.1 to 10.5, published by the Council of Europe are reproduced either in this edition of the British Pharmacopoeia or in the associated edition of the British Pharmacopoeia (Veterinary).
  • All monographs and requirements of the European Pharmacopoeia(Ph. Eur.) are reproduced in the BP, making the BP a convenient and fully comprehensive set of standards that can be used across Europe and beyond.


Product Description
  • New, legally enforced standards, available from 1 August 2021.All European Pharmacopoeia texts included. Updated annually, the British Pharmacopoeia (BP) is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products.
  • It includes approximately 4,000 monographs which are legally enforced by the Human Medicines Regulations 2012. Medicinal products or active pharmaceutical ingredients sold or supplied in the UK must comply with the relevant monograph.
  • All monographs and requirements of the European Pharmacopoeia (Ph. Eur.) are reproduced in the BP, making the BP a convenient and fully comprehensive set of standards that can be used across Europe and beyond.


Coronavirus and the British Pharmacopoeia
  • During the coronavirus (COVID-19) outbreak, the British Pharmacopoeia pledged to keep its users informed and to assist the larger healthcare response. The British Pharmacopoeia has prioritized the continued availability of written and physical standards as part of this, while also contributing staff and expertise to the Medicines and Healthcare products Regulatory Agency (MHRA) and participating in international pharmacopoeial initiatives. 
  • British Pharmacopoeia standards are now more widely available, including the free publication of relevant supportive pharmacopoeial texts in collaboration with the European Pharmacopoeia. This ensured that those developing, manufacturing, and testing medicines in response to the COVID-19 pandemic had ready access to the necessary standards.

BP 2022 Monographs and content
  1. 25 new BP monographs, 38 new Ph. Eur. monographs.
  2. 133 amended BP monographs.
  3. All monographs from the Ph. Eur. 10th edition as amended by Supplements 10.1 to 10.5are included.
  4. Ph. Eur. supplements 10.6, 10.7, and 10.8 are included as in-year online and download product updates.

Homoeopathic Preparations; Traditional Herbal Medicines
  • This edition contains one new British Pharmacopoeia monograph on herbal medicine (Tinospora Stem). This reflects a continued commitment to providing quality standards for herbal drugs commonly used in the UK as well as those known to be used in traditional medicine preparation. The Herbal and Complementary Medicines Expert Advisory Group reviewed the work plan and will continue to develop useful standards that benefit users.


Unlicensed Medications
  • This new edition includes four additional monographs for unlicensed formulations. All monographs for such formulations include a statement stating that the monograph was prepared to cover unlicensed formulations. The general and individual monographs are intended to apply to all types of Unlicensed Medicines, including those prepared under a Manufacturer's 'Specials' Licence and those prepared extemporaneously under the supervision of a pharmacist.
  • A new section on Ready-to-Administer Injections has been added to the Supplementary Chapter on the Aseptic Preparation of Unlicensed Medicines (01 F). These items are widely available and can be used in the home. They are prepared in aseptic preparation units and kept in a ready-to-administer form until they are administered to patients.

New Analytical Technologies
  • In the BP 2022, LCIUV-DAD (Diode Array Detection), also known as photo-diode array (PDA) detection, has been introduced as a routine identification test option in BP monographs. This is the result of a favourable response to a change proposal made available through the regular review schedule for draft texts.

Analytical Quality by Design (AQbD)
  • The British Pharmacopoeia, working with the MHRA and stakeholders, continues to investigate the application of Quality by Design principles to analytical methods and pharmacopoeia. Several AQbD concepts have been assessed practically in conjunction with the British Pharmacopoeia Commission Laboratory, and the Australian Therapeutic Goods Administration. The MHRA published the outcomes of these studies with an accompanying public consultation I.
  • Consultation responses underscored the importance of AQbD concepts as potentially transformative catalysts for enabling innovation for analytical methods and ultimately further supporting the assurance of medicines quality. The result of the consultation has been the adoption of a strategy and accompanying work programme that will continue to drive forward this important area of regulatory science. The first outcome of this work programme, Supplementary Chapter on the use of Analytical Quality by Design concepts for analytical procedures, is included in this publication. The selective guidance this Supplementary Chapter provides will support users in the application of Analytical Quality by Design principles to pharmacopoeial procedures and across the entire Analytical Method Lifecycle.
  • In recognition of the importance of alignment between regulators, pharmacopoeias and stakeholders, a joint online workshop between the MHRA and United States Pharmacopeia on the pharmacopoeial application of AQbD and Analytical Method Lifecycle concepts was held in February 2021. The workshop included speakers from industry, ICH Expert Working Groups, the MHRA and United States Pharmacopeia.
  • The British Pharmacopoeia Commission has caused this British Pharmacopoeia 2022 to be prepared under regulation 317(1) of the Human Medicines Regulations 2012 and, in accordance with regulation 317(4), the Ministers have arranged for it to be published.
  • The British Pharmacopoeia 2022 contributes significantly to the quality control of medicinal products for human use. It contains publicly available, legally enforceable standards that provide an authoritative statement of the quality that a product, material or article is expected to meet at any time during its period of use. The pharmacopoeial standards are designed to complement and assist the licensing and inspection processes and are part of the overall system for safeguarding the health of purchasers and users of medicinal products in the UK.
  • The British Pharmacopoeia also has an important role to play internationally, being used across the globe and referenced in the national legislation of several countries. The British Pharmacopoeia Commission wishes to record its appreciation of the services of all those who have contributed to this important work.
  • The British Pharmacopoeia 2022 supersedes the British Pharmacopoeia 2021. It has been prepared by the British Pharmacopoeia Commission, with the collaboration and support of its Expert Advisory Groups, Panels of Experts and Working Parties and contains approximately 4000 monographs for substances, preparations and articles used in the practice of medicine.
  • Some of these monographs are of national origin and have been elaborated or revised under the auspices of the British Pharmacopoeia Commission whilst others (indicated to users by a chaplet of stars) have been elaborated, or revised, under the auspices of the European Pharmacopoeia Commission, supported by its Groups of Experts and Working Parties, and are reproduced from the European Pharmacopoeia. This edition, together with its companion volume, the British Pharmacopoeia (Veterinary) 2022, incorporates all the monographs of the lOth Edition of the European Pharmacopoeia, as amended by Supplements 10.1 and 10.5. Users of the British Pharmacopoeia thereby benefit by finding within this comprehensively indexed compendium all current United Kingdom pharmacopoeia standards for medicines for human use.

Volume

Content

Volumes I and II

Medicinal Substances

Volume III

Formulated Preparations: General Monographs

Formulated Preparations: Specific Monographs

Volume IV

 

Herbal Drugs, Herbal Drug Preparations and

Herbal Medicinal Products Materials for use in the Manufacture of Homoeopathic Preparations

Blood-related Products

Immunological Products

Radiopharmaceutical Preparations

Surgical Materials

Volume V

Infrared Reference Spectra

Appendices

Supplementary Chapters

Index



British Pharmacopoeia 2022 five Volume (Volume I to Volume V) in pdf are available here.

VOLUME I


VOLUME II


VOLUME III


VOLUME IV


VOLUME V

PEOPLE ALSO READ: British Pharmacopoeia 2020 pdf

Post a Comment

0 Comments

close