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British Pharmacopoeia 2018 Software
The British Pharmacopoeia 2018 replaces the British Pharmacopoeia 2019. It was prepared by the British Pharmacopoeia Commission in collaboration and support of expert advisory groups, expert panels and working groups and used around 4,000 monographs for substances, preparations and articles in practice medicine. Some of these monographs are of national origin and are drafted or edited under the supervision of the British Pharmacopoeia Commission, while others (identified by users with a wreath or asterisks) are drafted or edited under the auspices of the European Pharmacopoeia Commission, supported by its expert groups and working groups and taken from the European Pharmacopoeia. . This edition, together with the accompanying volume, British Pharmacopoeia (Veterinary) 2018, includes all monographs of the 9th edition of the European Pharmacopoeia, as amended by Appendices 9.1 to 9.8. UK Pharmacopoeia users thus benefit from searching this comprehensive indexed overview of all current UK pharmaceutical standards for medicinal products for human use.
Effective date
The effective date for the British Pharmacopoeia monographs in this issue is 1 January 2018.
National monographs removed from these or previous editions of the British Pharmacopoeia remain in force in accordance with Regulation 252 (2) (c) Human Medicines Regulations 2012.
The implementation dates of the European Pharmacopoeia publications are listed in the next Chapter IV B: Implementation dates. The monographs of the European Pharmacopoeia are marked with an asterisk next to the title.
Appendices
A list of monographs first included in the British Pharmacopoeia 2018 is given at the end of this introduction. It includes 35 new monographs of national origin and new monographs copied from the 9th edition of the European Pharmacopoeia, as amended by Appendices 9.1 to 9.8.
Pharmacopoeial - Public quality standards for biological drugs
The Agency for the Regulation of Medicines and Health Products (MHRA) continues to implement its strategy for pharmacopoeial public quality standards for biological medicines published in 20171. the default function.
Part of the published strategy is to explore alternative approaches to standards for biological medicines. This led to the establishment in 2018 of a working group on alternative approaches to documentary and physical standards for biotechnology products (WP BIO-DPS). an alternative approach to these issues while continuing to support innovation throughout the product life cycle. The working group examines ideas for new concepts in standards, including performance and class standards, and how you can evaluate the value and potential implementation of such concepts.
The strategy also emphasizes the need to explore and maintain documentation opportunities and physical standard settings for advanced therapy medicinal products (ATMPs). MHRA works with groups in the ATMP community to improve their understanding of the challenges and needs of the ATMP community and the role of standards in promoting innovation and product quality assurance.
Discussion of Dissolution
The response to the dissolution discussion was published in January 2019 and included stakeholder feedback and suggestions submitted by the Pharmaceutical Experts Advisory Group and the British Pharmacopoeia Commission. The response document outlines revised melt testing principles. BP responds to each of these points with a clear action plan specifying how this policy will be implemented.
BP 2018 includes an initial revision of Chapter I E (dissolution tests of solid oral dosage forms) and a change in the order of additives. These initial changes to the pharmacopoeial digestion test support information are the first step in implementing this revised policy.
Traditional herbal preparations; Homeopathic preparations
Two new BP monographs for herbal medicines have been included in this issue. They demonstrate a continuing commitment to providing standards for herbal medicines commonly used in the UK and for those known to be used in the preparation of traditional medicines. Annex XI V: Deoxyribonucleic Acid (DNA) -based herbal drug identification techniques have been updated to provide a working example of DNA-based identification of Tribulus terrestris. Additional Chapter VII D: DNA bar coding as a tool for botanical identification of herbal drugs has also been updated to include a reference order for Tribulus terrestris Fruit and Galium aparine L. (Cliveers). If individual monographs have a reference sequence, a non-binding annex informing the user about the published reference sequence in Additional Chapter VII D is attached to the monograph.
Unlicensed drugs
With this new edition, another 5 monographs have been added for the unlicensed version. All monographs for such wording are described in the statement that the monograph is prepared for an unlicensed version. General and individual monographs are intended for use on all types of unlicensed drugs, ie formulations prepared under a "special" manufacturer's license and prepared at the time of preparation under the supervision of a pharmacist.
The general monograph on unlicensed drugs has been amended to indicate that alternative sterility testing methods may be required for sterile preparations prepared in advance or in small doses.
Analytical quality according to design (AQbD)
The British Pharmacopoeia, in collaboration with the MHRA and stakeholders, is investigating the application of the Quality by Design concept to analytical methods and pharmacopoeia. Various AQbD concepts have been practically tested in conjunction with the British Pharmacopoeia Laboratory, including: risk analysis, design experiments (DoE) and analytical target profiles (ATP). The Australian Therapeutic Goods Administration was also a major contributor to the project.
The MHRA recognizes the importance of coordination between regulators, pharmacopoeias and stakeholders in the development of new and innovative policies, such as the application of the AQbD principles. The results of this work should therefore be published before the publication of BP 2018. The MHRA will also publish a joint consultation to find stakeholder views on how AQbD concepts can be applied in the context of a pharmacopoeia.
Revision
A significant number (331, consisting of 103 technical versions and 228 editorial versions) of national monographs were edited by this edition. In these monographs, those with major technical changes are mentioned at the end of this introduction. For readers, this list lists the section as a section of each monograph that has been updated.
The list of versions added to this introduction is as complete as possible. However, in order for the reader to be able to use the current standard, it is important to refer to the full text of each individual monograph.
For texts reproduced from the European Pharmacopoeia, the database of the European Directorate for the Quality of Medicines and Healthcare (EDQM) (see Website below) provides information on versions of monographs or other texts on a historical basis, starting with the 5th edition of the European Pharmacopoeia. British Pharmacopoeia Chemical Reference Substances (BPCRS)
The British Pharmacopoeia 2018 Software continues to expand the BPCRS catalog of key elements of published monographs. The catalog currently contains more than 800 items. The British Pharmacopoeia Commission Laboratory is constantly working to improve the percentage of BPCRS in stock and is working to create a BPCRS to support new monographs for BP 2018 and future editions available to our users at the same time. if publication is available and after the date of implementation.
Name changes
British Pharmacopoeia 2018 Software 108 monograph titles were edited in this issue. Following the decision of the British Pharmacopoeia Commission to change the titles of the monograph to include the distribution of the standard term, changes were made to the titles of the hits in the monograph in this issue and included in the list of appendices. Loss
73 monographs have been removed from the British Pharmacopoeia 2018. A list of discarded monographs will be added at the end of this introduction.
Infrared reference spectra
As in the previous edition, the reference spectra in this edition are arranged in alphabetical order. Six new spectra were added to the collection.
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