British Pharmacopoeia 2022 (BP 2022) pdf free download

British Pharmacopoeia 2022 five Volume (Volume I to Volume V) in pdf form are available here, you can download it from here for free.

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).

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The British Pharmacopoeia and coronavirus

During the coronavirus (COVID-19) outbreak the British Pharmacopoeia has committed to keeping its users updated and to supporting the wider healthcare response. As part of this the British Pharmacopoeia has prioritised the continued availability of written and physical standards, while also contributing staff and expertise to the Medicines and Healthcare products Regulatory Agency (MHRA) and participated in international pharmacopoeial initiatives. Availability of British Pharmacopoeia standards has been extended and expanded, including the free access publication of relevant supportive pharmacopoeial texts in cooperation with the European Pharmacopoeia. This has ensured that those developing, manufacturing and testing medicines in response to the COVID-19 pandemic have had ready access to the standards required.

Traditional Herbal Medicines; Homoeopathic Preparations

One new British Pharmacopoeia monograph for herbal medicine is included in this edition (Tinospora Stem). This reflects a continued commitment to providing quality standards for herbal drugs commonly used in the UK and

for those known to be used for the preparation of traditional medicines. The Herbal and Complimentary Medicines Expert Advisory Group has reviewed the work programme and will continue to develop useful standards that add value to users.

Unlicensed Medicines

With this new edition, a further four monographs for unlicensed formulations have been added. All monographs for such formulations are characterised by a statement that the monograph has been prepared to cover unlicensed formulations. The general and individual monographs are intended to apply to all types of Unlicensed Medicines, that is, those formulations prepared under a Manufacturer's 'Specials' Licence and those prepared extemporaneously under the supervision of a pharmacist.

The Supplementary Chapter on the Aseptic Preparation of Unlicensed Medicines 01 F) has been updated to include a new section on Ready-to Administer Injections. Such products are widely available and may be used in the home environment. They are prepared in aseptic preparation units and ate stored in a ready-to-administer form until administered to the patient.

New Analytical Technologies

LCIUV-DAD (Diode Array Detection), also known as a photo-diode array (PDA) detection, has been introduced as a routine identification test option in BP monographs in the BP 2022. This follows from a positive response to a change proposal made available via 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 the 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 within 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 pharmacopoeial application of AQbD and Analytical Method Lifecyle 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.

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
Volume VI	British Pharmacopoeia (Veterinary) 2020