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EUROPEAN PHARMACOPOEIA Free Access to Supportive Pharmacopoeial Texts in the Field of Vaccines for Human Use During the Coronavirus Disease (COVID-19) Pandemic

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EUROPEAN PHARMACOPOEIA Free Access to Supportive Pharmacopoeial Texts in the Field of Vaccines for Human Use During the Coronavirus Disease (COVID-19) Pandemic EUROPEAN PHARMACOPOEIA Free access to supportive pharmacopoeial texts in the field of vaccines for human use during the coronavirus disease (COVID-19) pandemic Updated package - October 2020 Published in accordance with the Convention on the Elaboration of a European Pharmacopoeia (European Treaty Series No. 50) European Directorate Direction européenne for the Quality de la qualité of Medicines du médicament & HealthCare & soins de santé Council of Europe Strasbourg Free access to supportive pharmacopoeial texts in the field of vaccines for human use during the coronavirus disease (COVID-19) pandemic Updated package The EDQM is committed to supporting users during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and providing access to relevant guidance/standards. To support organisations involved in the development, manufacture or testing of COVID-19 vaccines worldwide, many of which are universities and small and medium-sized enterprises, the EDQM is offeringte mporary free access to texts of the European Pharmacopoeia (Ph. Eur.) in the field of vaccines. This package includes quality standards for vaccines which developers can take into account to help build appropriate analytical control strategies for their COVID-19 candidate vaccines and ensure the quality and safety of the final product. Application of such quality requirements may ultimately help to facilitate regulatory acceptance of a subsequent marketing authorisation application. For ease of reading, a summary table listing the pharmacopoeial texts, with information regarding the vaccine types or vaccine platforms concerned (e.g. live attenuated viral vaccine, recombinant viral-vectored vaccines) is provided. The list of texts is not exhaus- tive and will be reviewed regularly and updated as required. The pharmacopoeial texts comprise overarching general texts (general notices, general monographs, dosage form monographs and general chapters) as well as selected indivi- dual vaccine monographs and analytical methods. The texts are from the 10th Edition of the Ph. Eur., including Supplement 10.4. This publication will be available on the EDQM website (https://go.edqm.eu/Pheurvac- cinespackage) until further notice. It will be withdrawn when appropriate. This in no way affects the existing legal status of the European Pharmacopoeia, nor does it imply or confer any demonstrated effectiveness of a particular vaccine type or vaccine platform for the prevention of COVID-19. This is confirmed by the inclusion of the following text at the bottom of pharmacopoeial texts reproduced in this document: “Not official text. Please refer to the current legallyffective e version of the Pharmacopoeia to ensure compliance.” The package was updated on 25 October 2020 to include additional Ph. Eur. texts. All rights reserved. Apart from any fair dealing for the purposes of research or private study, this publication may not be reproduced or transmitted in any form or by any means without the prior permission in writing of the publisher. If you have any questions or comments please contact the EDQM via the mailbox: [email protected]. The European Pharmacopoeia is published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM). © Council of Europe, 67075 Strasbourg Cedex, France - 2020 TEXT N° TITLE PRODUCT TYPE(S) General Notices 1. General Notices General monographs 2034 Substances for pharmaceutical use All vaccines. 2619 Pharmaceutical preparations All vaccines. 0153 Vaccines for human use All vaccines. 0784 Recombinant DNA technology, products of Recombinant protein-based vaccines. 1483 Products with risk of transmitting agents of Vaccines produced using material of animal origin. animal spongiform encephalopathies Dosage form monographs 0520 Parenteral preparations Vaccines for parenteral administration. 0676 Nasal preparations Vaccines for nasal administration. General chapters 5.2.1 Terminology used in monographs on biological All vaccines. products 5.2.2 Chicken flocks free from specified pathogens Vaccines produced in specified pathogen-free primary for the production and quality control of avian tissues. vaccines 5.2.3 Cell substrates for the production of vaccines Vaccines using cell cultures for production. for human use 2.6.16 Tests for extraneous agents in viral vaccines for Live attenuated viral vaccines, inactivated viral human use vaccines, recombinant viral vectored vaccines. 5.1.7 Viral safety Vaccines produced using material of human or animal origin. 5.2.8 Minimising the Risk of Transmitting Animal Vaccines produced using material of animal origin. Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products 5.14 Gene transfer medicinal products for human Certain considerations may be relevant to recom- use binant viral vectored vaccines using adenovirus or poxvirus as backbone, and to DNA vaccines. TEXT N° TITLE PRODUCT TYPE(S) methods of analysis 2.6.1 Sterility All vaccines1. 5.1.6 Alternative methods for control of microbiolo- All vaccines2. gical quality 2.6.2 Mycobacteria Vaccines using cell cultures or primary avian tissues for production. 2.6.7 Mycoplasmas Vaccines using cell cultures or primary avian tissues for production. 5.1.3 Efficacy of antimicrobial preservation Multi-dose vaccines containing a preservative. 2.6.14 Bacterial endotoxins All vaccines1. 5.1.10 Guidelines for using the test for bacterial All vaccines1. endotoxins 2.7.2 Microbiological assay of antibiotics Where antibiotics are used during the production process3, the residual antibiotic concentration may be determined by a microbiological assay adapted from chapter 2.7.2 or by other suitable methods (e.g. liquid chromatography). 2.6.34 Host-cell protein assays Recombinant protein-based vaccines and purified recombinant viral vectored vaccines. 2.5.33 Total protein Certain live attenuated viral vaccines and recombinant viral vectored vaccines that are less amenable to purification. 2.6.35 Quantification and characterisation of residual Vaccines produced in continuous cell lines4. host-cell DNA 2.2.29 Liquid chromatography When the method is selected. 2.6.21 Nucleic acid amplification techniques When the method is selected. 2.7.1 Immunochemical methods When the method is selected. 2.7.24 Flow cytometry When the method is selected. 2.2.1 Clarity and degree of opalescence of liquids Vaccines in liquid form, lyophilised vaccines after reconstitution. 2.2.2 Degree of coloration of liquids Vaccines in liquid form, lyophilised vaccines after reconstitution. 2.2.3 Potentiometric determination of pH Vaccines in liquid form, lyophilised vaccines after reconstitution. 2.2.35 Osmolality Vaccines for parenteral administration. 2.5.12 Water: semi-micro determination Lyophilised vaccines. 2.9.17 Test for extractable volume of parenteral Vaccines for parenteral administration. preparations 2.9.20 Particulate contamination: visible particles Vaccines in liquid form, lyophilised vaccines after reconstitution. 1 Unless otherwise justified and authorised, as described in the General Monograph Vaccines for human use (0153). 2 A comprehensive validation package, including the demonstration of equivalence with the compendial test, is a prerequi- site when opting to use alternative microbiological methods for sterility. 3 It is preferable to have a production free from antibiotics. Unless otherwise justified, at no stage during production is penicillin or streptomycin used. 4 See also General Chapter 5.2.3. Cell substrates for the production of vaccines for human use. TEXT N° TITLE PRODUCT TYPE(S) Individual vaccine monographs Examples of individual monographs for various types of vaccines. The following examples demonstrate the applicable requirements for specific products. They can be taken as guidance and should be considered for vaccines in a similar class without a specific monograph. 2441 Human papillomavirus vaccine (rDNA) Recombinant protein-based vaccines. Production in an insect cell / baculovirus expression vector system. 1056 Hepatitis B vaccine (rDNA) Recombinant protein-based vaccines. Production in CHO cells. 0214 Poliomyelitis vaccine (inactivated) Inactivated viral vaccines. 0537 Yellow fever vaccine (live) Live attenuated viral vaccines. Certain considerations may be relevant to recom- binant viral vectored vaccines using yellow fever virus or other viruses as backbone. 0213 Measles vaccine (live) Live attenuated viral vaccines. Certain considerations may be relevant to recom- binant viral vectored vaccines using measles virus or other viruses as backbone. 2772 Influenza vaccine (live, nasal) Live attenuated viral vaccines for nasal adminis- tration. Certain considerations may be relevant to recom- binant viral vectored vaccines using influenza virus or other viruses as backbone. Monographs on adjuvants 1664 Aluminium hydroxide, hydrated, for Vaccines containing aluminium hydroxide as adsorption adjuvant. 2805 Squalene Vaccines containing a squalene-based adjuvant. General Notices TEXT N° TITLE PRODUCT TYPE(S) 1. General Notices Please refer to the current legally effective version of the Pharmacopoeia to access the official standards. EUROPEAN PHARMACOPOEIA 1. General notices 07/2014:10000 (2) An enhanced approach to quality control could utilise corrected 10.0 process analytical technology (PAT) and/or real-time release testing (including parametric release) strategies as alternatives to end-product testing alone. Real-time
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