EP 10 (EUROPEAN PHARMACOPOEIA 10th) pdf free download
You can also download other book from
European Pharmacopoeia 10.0
EUROPEAN PHARMACOPOEIA VOLUME I
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
Just a few years back, in 2014, we commemorated the 50th anniversary of the European Pharmacopoeia. Now, in 2019, we’re celebrating another milestone with the release of the 10th edition of this essential reference for medicinal product quality. For EP 11 (EUROPEAN PHARMACOPOEIA 11th EDITION)
Since its inception in 1964 by the eight founder countries, the world has undergone significant changes. Today, in our interconnected global landscape, medicinal products, active substances, and excipients are manufactured and distributed worldwide. The European Pharmacopoeia has evolved in tandem with this globalization, emerging as a key reference point for medicine quality in Europe and beyond. Its standards, enshrined within its pages, serve as legally binding benchmarks across the 38 member states and the European Union who are parties to the Convention on the European Pharmacopoeia.
Over the past three years, the European Pharmacopoeia community has expanded, with the Republic of
Moldova joining the Convention in 2017 and three new observer states—India and Japan in 2016, and the Republic of Uzbekistan in 2018—signifying its enduring appeal and vitality. Notably, the participation of six European countries, twenty-two non-European countries, along with observers like the Taiwan Food and Drug Administration of the Ministry of Health and Welfare (TFDA) and the World Health Organization (WHO), underscores the global impact of the European Pharmacopoeia. It’s evident that beyond safeguarding the health of millions of European citizens, the European Pharmacopoeia wields influence worldwide.
The European Pharmacopoeia’s operations are overseen by the European Directorate for the Quality of Medicines & HealthCare (EDQM). This involves the collaborative efforts of 20 expert groups and approximately 40 active working parties, comprising over 700 members from Europe and beyond. Since 2016, the inclusion of experts from worldwide locations has been implemented to reflect the globalized market landscape, enhancing the depth of discussions within these groups.
I firmly believe that all contributors to the European Pharmacopoeia can take great pride in maintaining
and updating a comprehensive collection of over 2500 texts, each requiring unanimous agreement from member states. This achievement underscores humanity’s ability to surmount barriers and cultural disparities. As we commemorate the release of the 10th Edition, it’s an opportune moment to reflect on its evolution from the inaugural edition spanning 1968 to 1976, originally published in three bound volumes.
The 2nd Edition, released in 1980, was presented in a loose-leaf binder format, with a new fascicle
published every mid-year, comprising all texts adopted by the European Pharmacopoeia Commission in the preceding year. This edition concluded with the issuance of fascicle 19 in 1995.
Moving to the 3rd Edition, the European Pharmacopoeia expanded to encompass around 1200 texts and
was made available for the first time in electronic format (CD-ROM) alongside a bound A4 version. The Commission continued to update its general chapters through a program of revisions and new developments.
Noteworthy additions to the general chapters included:
– Introduction of Chemical Imaging (5.24), a pioneering chapter in any pharmacopoeia globally,
offering specific recommendations for evaluating the performance of chemical imaging systems utilized in qualitative and quantitative analyses.
– Inclusion of Process Analytical Technology (5.25), emphasizing the integration of analytical
techniques into the manufacturing process to enhance process control and understanding.
– Incorporation of Scanning Electron Microscopy (2.9.52), with a focus on its application to
pharmaceutical materials across research and quality control.
Revision efforts targeted key general chapters such as:
– Loss on Drying (2.2.32)
– Osmolality (2.2.35)
– Infrared Absorption Spectrophotometry (2.2.24)
– Absorption Spectrophotometry, Ultraviolet and Visible (2.2.25)
Furthermore, the Commission refined its implementation strategy for the ICH Q3D Guideline on
elemental impurities. It adopted revised versions of general monographs on Substances for Pharmaceutical Use (2034) and Pharmaceutical Preparations (2619), along with updated versions of general chapters on Elemental Impurities (5.20) and Determination of Elemental Impurities (2.4.20). Numerous individual monographs were also revised in line with the implementation of the ICH Q3D
guideline within the European Pharmacopoeia.
An important milestone was reached in establishing quality standards for Live Biotherapeutic Products
(LBPs) containing live microorganisms like bacteria or yeasts. This included the adoption of quality standards for LBPs for human use, encompassing the general monograph Live Biotherapeutic Products for Human Use (3053) and two 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 Microorganisms (2.6.38).
The Committee on Medicinal Products (COM) has made significant revisions to key monographs
pertaining to pharmaceutical products derived from recombinant DNA technology and substances for pharmaceutical use. Specifically, the general monograph on Products of recombinant DNA technology (0784) has been updated to align with recommendations from international regulatory bodies such as the International Council for Harmonisation (ICH), the European Medicines Agency (EMA), and the
World Health Organization (WHO). This revision encompasses restructuring and modernizing the Production section in accordance with industry guidelines.
Similarly, revisions have been made to the general monograph on Substances for Pharmaceutical Use (2034) to clarify requirements for the bacterial endotoxin test, consistent with the COM’s approved policy. This aligns with the updated chapter on Guidelines for Using the Test for Bacterial Endotoxins (5.1.10.) in the European Pharmacopoeia Supplement 8.8. Furthermore, references to guidelines have been updated, such as replacing the Guideline on the Limits of Genotoxic Impurities with the new Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (ICH M7).
Improvements in analytical performance have been achieved through the introduction of a general
chapter on high-performance thin-layer chromatography of herbal drugs and herbal drug preparations (HPTLC, 2.8.25) in the Pharmacopoeia. This method enhances selectivity and enables objective evaluation of observed zones through intensity markers, alongside standardized plate preparation and electronic
documentation of chromatograms.
Efforts to reduce animal testing in scientific procedures align with the COM’s commitment to the 3Rs
principles (replacing, reducing, and refining the use of animals). A new chapter on the Substitution of in vivo methods by in vitro methods for the quality control of vaccines (5.2.14) facilitates the transition to alternative methods. This guidance includes instructions on validating in vitro methods when direct comparison with in vivo methods is not feasible. As a result, revised versions of general monographs on Vaccines for human use (0153) and Vaccines for veterinary use (0062) have been adopted to promote the use of alternatives and minimize animal testing. Additionally, the COM has endorsed the removal of the test for abnormal toxicity from the Pharmacopoeia, leading to the revision of 49 monographs, with a significant reduction in animal testing, particularly in the domain of human vaccines.
The section on Abnormal toxicity (2.6.9) has been deemed outdated and consequently removed from the Ph. Eur.
Additionally, efforts have been made by the Committee of Experts (COM) to replace hazardous chemicals
whenever feasible, resulting in the revision of various monographs and chapters. While not exhaustive, this effort showcases the proactive nature of the Ph. Eur. and the collaborative spirit among the COM, National Pharmacopoeia Authorities, and experts from member countries and beyond in keeping up with
advancements.
During this period, several new working parties have been established or previously inactive ones
revitalized to address emerging concerns:
– A Working Party on Pyrrolizidine Alkaloids (PA WP) was established to formulate a general testing
method for Pyrrolizidine alkaloids (2.8.26). This decision stemmed from requests by European regulators and reports from some Ph. Eur. member states regarding contamination of herbal medicinal products and foodstuffs with plants containing pyrrolizidine alkaloids.
– The Working Party on Gene Therapy Products has been reactivated in response to recent developments
in the field. Its mandate includes revising the general chapter on Gene transfer medicinal products for human use (5.14) to incorporate newly developed pharmacopoeial texts like the general chapter on Raw materials of biological origin for the production of cell-based and gene therapy medicinal products
(5.2.12). This Working Party will also contribute to the revision of cross-cutting texts developed by other expert groups or working parties within the Ph. Eur., such as the general chapter on Quantification and
characterisation of residual host cell DNA (2.6.35).
Furthermore, the COM has initiated efforts to explore innovative approaches for areas where existing
methods have shown limitations.
One instance involves the pilot phase for monographs on traditional Chinese medicine (TCM), wherein
researchers are exploring the potential transition from liquid chromatographic assays to semiquantitative HPTLC. The objective is to illustrate that similar pass-fail determinations for analytical markers can be achieved and that fingerprinting may offer a more insightful characterization of complex mixtures, such as herbal drugs.
Additionally, the Committee of Experts (COM) has recognized semiquantitative fingerprinting as a
promising approach to addressing the challenges posed by homoeopathic preparations. This acknowledgment has prompted the reactivation of key items on the work program related to this issue.
Before concluding, I extend my gratitude to all members of the European Pharmacopoeia Commission for
their unwavering trust and support, which have facilitated significant progress across various fronts. Special acknowledgment is due to Dr. Susanne Keitel, Director of the EDQM, my esteemed vice-chairs, Prof. Torbjörn Arvidsson and Dr. Hilda Köszegi Szalai, as well as the Secretary to the European Pharmacopoeia Commission, Ms. Cathie Vielle, and her deputies, Dr. Emmanuelle Charton and Dr.
Ulrich Rose, for their exceptional contributions and support during my tenure as Chair.
Our collaborative and open exchanges have effectively guided the Commission’s work, making my role a
rewarding experience. Lastly, I express heartfelt appreciation to all chairs, experts in groups of experts and working parties, along with the staff of the EDQM and the National Pharmacopoeia Authorities. It is your enthusiasm, diligence, and teamwork that sustain the European Pharmacopoeia, ensuring the continued
quality of medicines for the well-being of patients for years to come.
You can also download other book from
European Pharmacopoeia 10.1 Edition
