EP 10 (EUROPEAN PHARMACOPOEIA 10th EDITION) pdf free download
I. PREFACE
II. INTRODUCTION
III. EUROPEAN PHARMACOPOEIA COMMISSION
IV. CONTENTS OF THE 10TH EDITION
GENERAL CHAPTERS
1. General notices
2. Methods of analysis
2.1. Apparatus
2.2. Physical and physico-chemical methods
2.3. Identification
2.4. Limit tests
2.5. Assays
2.6. Biological tests
2.7. Biological assays
2.8. Methods in pharmacognosy
2.9. Pharmaceutical technical procedures
3. Materials for containers and containers
3.1. Materials used for the manufacture of containers
3.2. Containers
3.3. Containers for human blood and blood components, and materials used in their manufacture;
transfusion sets and materials used in their manufacture; syringes
4. Reagents
5. General texts
GENERAL MONOGRAPHS
MONOGRAPHS ON DOSAGE FORMS
MONOGRAPHS ON VACCINES FOR HUMAN USE
MONOGRAPHS ON VACCINES FOR VETERINARY USE
MONOGRAPHS ON IMMUNOSERA FOR HUMAN USE
MONOGRAPHS ON IMMUNOSERA FOR VETERINARY USE
MONOGRAPHS ON RADIOPHARMACEUTICAL PREPARATIONS AND STARTING MATERIALS FOR RADIOPHARMACEUTICAL PREPARATIONS
MONOGRAPHS ON SUTURES FOR HUMAN USE
MONOGRAPHS ON SUTURES FOR VETERINARY USE
MONOGRAPHS ON HERBAL DRUGS AND HERBAL DRUG PREPARATIONS
MONOGRAPHS ON HOMOEOPATHIC PREPARATIONS
VOLUME II
MONOGRAPHS A - K
VOLUME III
MONOGRAPHS L - Z
Only a few years ago, in 2014, we had occasion to commemorate the 50th year anniversary of the European Pharmacopoeia. This year, in 2019, we have another jubilee to celebrate, with the publication of the 10th edition of this fundamental reference work for the quality of medicinal products.
The world has changed considerably since the 8 founder countries started the work on the European Pharmacopoeia in 1964. Today we live in a globalised world where goods – including medicinal products, active substances and excipients are produced and distributed all around the planet. The European Pharmacopoeia has kept pace with this development: it is today a European single point of reference for the quality of medicines, with a global influence. The texts published within its pages provide a public, legally binding standard in the 38 member states and the European Union (EU) which are signatories to the Convention on the elaboration of a European Pharmacopoeia.
The European Pharmacopoeia community has continued to grow in the past 3 years, with the accession of the Republic of Moldova to the Convention in 2017 and the arrival of 3 new observer states (India and Japan in 2016 and the Republic of Uzbekistan in 2018), clearly illustrating the lasting appeal and dynamism of the European Pharmacopoeia. The are markable fact that today 6 European countries, 22 non-European countries, the Taiwan Food and Drug Administration of the Ministry of Health and Welfare (TFDA) and the World Health Organization (WHO) are observers, illustrates that the European Pharmacopoeia serves not only the health of several hundreds of millions of European citizens, but also has a worldwide impact.
The activities of the European Pharmacopoeia are coordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). The work is carried out by 20 groups of experts and around 40 active working parties, together consisting of more than 700 members and involving experts from Europe and beyond. Since 2016, membership has also been extended to include experts from all around the world, a measure introduced to keep pace with the reality of market globalization and which has enriched discussions within the groups.
It is my personal conviction that everyone involved in the work of the European Pharmacopoeia can be very proud that it is possible to establish and keep updated a work containing more than 2500 texts, each of which can only be adopted with the unanimous agreement of the Ph. Eur. member states.
This is outstanding proof that humans can indeed overcome potential barriers and cultural differences. The publication of the 10th Edition of the European Pharmacopoeia is the ideal time to look back on its development from the 1st to the 10th Edition.
The 1st Edition was published as 3 bound volumes between 1968 and 1976.
The 2nd Edition, published in 1980, came in loose-leaf binder format with a new fascicle issued in the middle of each year, containing all the texts adopted by the European Pharmacopoeia Commission in the previous year. This 2nd Edition culminated with the publication of fascicle 19 in 1995.
By the 3rd Edition, the European Pharmacopoeia included approximately 1200 texts and was issued for the first time in both electronic format (CD-ROM) and as a bound A4
– The COM continued to update its general chapters through a programme of revisions and new elaborations.
New general chapters were adopted on:
– Chemical imaging (5.24), the first of its kind to be introduced in any pharmacopoeia worldwide. This chapter provides specific recommendations on how to assess the performance of chemical imaging systems used for qualitative and quantitative investigations.
– Process analytical technology (5.25) focusing on the interfacing of analytical techniques with the manufacturing process as a means of enhancing process control and improving process understanding.
– Scanning electron microscopy (2.9.52) concentrating on scanning electron microscopy applied to pharmaceutical materials, from research to quality control. Revision work targeted the widely used general chapters on:
– Loss on drying (2.2.32)
– Osmolality (2.2.35)
– Infrared absorption spectrophotometry (2.2.24)
– Absorption spectrophotometry, ultraviolet and visible (2.2.25)
– The COM further fine-tuned its implementation strategy for the ICH Q3D Guideline on elemental impurities and adopted the revised versions of its general monographs on Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619), as well as revised versions of the general chapters on Elemental Impurities (5.20) and on Determination of elemental impurities (2.4.20). Numerous individual monographs have been revised within the framework of the implementation of the ICH Q3D guideline in the Ph. Eur.
– An important milestone was also achieved in the setting of quality requirements for live biotherapeutic products (LBPs) – which are medicinal products that contain live micro-organisms such as bacteria or yeasts
- with the adoption of quality standards for LBPs for human use. These included the general monograph Live biotherapeutic products for human use (3053), and 2 general chapters, Microbial examination of
live biotherapeutic products: test for enumeration of microbial contaminants (2.6.36) and Microbiological examination of live biotherapeutic products: test for specified micro-organisms (2.6.38).
– A revised general monograph on Products of recombinant DNA technology (0784) was also adopted by the COM. This text provides general requirements for the manufacture and control of medicinal products derived from recombinant DNA technology and also includes requirements for the active substances in these products. Several parts of the text were updated, including the Production section of the monograph which has been entirely re-structured and modernised in line with the recommendations and guidelines published by the International Council for Harmonisation (ICH), the European Medicines Agency (EMA) and the World Health Organization (WHO).
– The general monograph on Substances for Pharmaceutical Use (2034) was revised to clarify the requirements for the bacterial endotoxin test and align them with the policy on the same topic approved by the COM at its 149th Session in June 2014. This revision goes hand-in-hand with the revision of the chapter on Guidelines for Using the Test for Bacterial Endotoxins (5.1.10.), published in European Pharmacopoeia Supplement 8.8, which also included recommendations for establishing limits, as well as information on how to evaluate the pyrogenicity of substances. The reference to the Guideline on the Limits of Genotoxic Impurities published by the EMA has also been replaced with a reference to the new Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (ICH M7).
– The analytical performance of chromatographic identification tests in monographs on herbal drugs and herbal drug preparations has improved since the general chapter on high-performance thin-layer chromatography of herbal drugs and herbal drug preparations (HPTLC, 2.8.25) was introduced in Ph. Eur. The new method not only improves selectivity but also allows a more objective evaluation of the observed zones through the use of intensity markers. The equipment described ensures standardised plate preparation, and includes a system for electronic documentation of chromatograms.
– The COM has continued its efforts to critically review the number of animals required to perform scientific procedures, revising the methods used in monographs and chapters, wherever possible, to ensure that the Ph. Eur. promotes the 3Rs principles of replacing, reducing and refining the use of animals in scientific procedures. An example of this effort is the adoption of a new chapter on the Substitution of in vivo methods by in vitro methods for the quality control of vaccines (5.2.14) to facilitate the transition from in vivo to in vitro methods. This chapter provides guidance on how to validate alternative in vitro methods in cases where a direct head-to-head comparison with an existing in vivo method is not possible. Following the adoption of thisnew chapter, the COM adopted a revised version of the general monograph on Vaccines for human use (0153) and on Vaccines for veterinary use (0062) to reduce animal testing and encourage the use of alternatives. In 2017, the COM endorsed the complete suppressin of the test for abnormal toxicity from the Ph. Eur. As part of this exercise, the COM adopted 49 monographs revised to remove this test, 36 of which concerned vaccines for human use. The general chapter Abnormal toxicity (2.6.9) became thus obsolete and was therefore deleted from the Ph. Eur.
– The COM has also pursued its efforts to replace the use of hazardous chemicals whenever possible leading to the revision of a number of monographs and chapters. This list – which is neither comprehensive nor exhaustive –illustrates the impressive dynamism of the Ph. Eur. and the willingness of the COM, together with National Pharmacopoeia Authorities and experts from membercountries and beyond, to keep pace with new developments. This period has also seen number of new working parties created or old ones reactivated to deal with emerging issues:
– A Working Party on Pyrrolizidine Alkaloids (PA WP) was created and tasked with the definition of a general method for testing Pyrrolizidine alkaloids (2.8.26). This decision was taken in response to a demand expressed by European regulators and following reports in some Ph. Eur. member states that herbal medicinal products, and foodstuffs, had been found to be contaminated with plants containing pyrrolizidine alkaloids.
– The Working Party on Gene Therapy Products has been reactivated in response to recent developments in the field. The Working Party has been tasked with the revision of general chapter Gene transfer medicinal products for human use (5.14) to take into account newly elaborated pharmacopoeial texts, such as general chapter Raw materials of biological origin for the production of cell-based and gene therapy medicinal products (5.2.12).This Working Party will also participate in the revision of transversal texts elaborated by other groups of expertsr working parties of the Ph. Eur., such as general chapter Quantification and characterisation of residual host cell DNA (2.6.35). Furthermore, the COM initiated activities to explore new approaches for areas where existing approaches showed limitations:
– One example is the pilot phase for monographs on traditional Chinese medicine (TCM) where the possible replacement of liquid chromatographic assays by semiquantitative HPTLC is under study. The goal is to demonstrate that the same pass-fail decision for the determination of analytical markers can be obtained and that fingerprinting may lead to more meaningful characterisation of multi-component mixtures, such as herbal drugs.
– The COM also identified semiquantitative fingerprintingas a potential new approach to tackling the challenges presented by homoeopathic preparations and has reactivated important items on the work programme concerned by this issue. Coming to the end of this preface, I would first like to thank all the members of the European Pharmacopoeia Commission for their trust and support that allowed us to make substantial progress on so many topics.
Special thanks go to the Director of the EDQM, Dr Susanne Keitel, my two vice-chairs, Prof Torbjörn Arvidsson and Dr Hilda Köszegi Szalai, the Secretary to the European Pharmacopoeia Commission, Ms Cathie Vielle, and her two deputies, Dr Emmanuelle Charton and Dr Ulrich Rose, for their excellent work and support during my time as Chair. Together, we had very open and constructive exchanges of thoughts, which have enabled us to guide the work of the European Pharmacopoeia Commission in an efficient and successful manner - and made my work a pleasure too.Finally, I would life to express my sincere gratitude to all the chairs and experts in groups of experts and working parties, as well as the staff of the EDQM and the National Pharmacopoeia Authorities.
The European Pharmacopoeia is only possible due to their omnipresent enthusiasm, hard work and collaboration. Thanks to your dedication and efforts, the European
Pharmacopoeia will continue to ensure the quality of medicines for the benefit of patients for many years to come. Dr Tobias Gosdschan, Chair of the European Pharmacopoeia Commission 28 February 2019.
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