The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. Volume five of this publications describes methods and procedures for the quality control of pharmaceutical substances and tablets, tests for dosage forms for suppositories and opthalmic preparations, and a new section on quality control of anti-malarials. Supplementary information on International Chemical Reference Substances and International Reference Spectra, and on the establishment, maintenance and distribution of chemical reference substances are also included.
The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.
This book provides a step-by-step guide to simple methods for verifying the identity of commonly used pharmaceutical substances and dosage forms. The basic tests described can also be used to detect mislabeled, substandard, or counterfeit products when the labeling or physical attributes give rise to doubt. Intended for use in developing countries, where resources and specialized skills may be scarce, all tests rely on a limited range of easily available reagents and equipment and need not be performed in a fully equipped laboratory or by persons with specialized training in pharmacy or chemistry. The book describes tests for 23 pharmaceutical substances and 58 pharmaceutical dosage forms, most of which are included in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plant materials are also included. As stressed in the text, these tests, which merely confirm identity, are intended for use as primary screening tools and may need to be followed, in cases of adverse test results, by a full pharmacopoeial analysis. The book opens with a brief description of the importance of basic tests as one of the many steps needed to ensure a supply of safe and effective drugs. Chapter two describes several collections of more sophisticated tests, including volumetric or spectrophotometric analysis and thin-layer chromatography, that can be useful in the primary screening of imported pharmaceutical substances, and dosage forms. Information on how to obtain and use these guides to tests, which have not been published by WHO is also provided. Against this background, the main part of the book sets out test procedures for verifying the identity of selected pharmaceutical substances, pharmaceutical dosage forms, and medicinal plant materials. The book concludes with a cumulative index of test procedures described here and in the related WHO publications "Basic Tests for Pharmaceutical Substances" and "Basic Tests for Pharmaceutical Dosage Forms".
This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Important topics were addressed such as regulatory guidance on interchangeability of medicines fix-dose combinations: how to regulate them new guidance in the area of good manufacturing practices (GMP) and stability testing and counterfeit medicines. In addition some 12 new monographs for antiretrovirals 6 new ones on TB drugs including 2- 3- and 4-fixed-dose preparations as well as monographs for antimalarial medicines are discussed in detail. Seven new specifications for antiretrovirals were adopted. The report also includes newly International Chemical Reference Substances for the series of artemisinin derivatives. The following new WHO guidelines were adopted and are annexed to the report: GMP: requirement for the sampling of starting materials (amendment to current text) GMP: water for pharmaceutical use guideline for sampling of pharmaceuticals and related materials guidelines for registration of fixed-dose combination medicinal products.
This adaptation of Bentley's Textbook of Pharmaceutics follows the same goals as those of the previous edition, albeit in a new look. The content of the old edition has been updated and expanded and several new chapters, viz. Complexations, Stability Testing as per ICH Guidelines, Parenteral Formulations, New Drug Delivery Systems and Pilot Plant Manufacturing, have been included, with an intention to make the book more informative for the modern pharmacists. The book has six sections: - Section I deals with the physicochemical principles. Two new chapters: Complexations and ICH Guidelines for Stability Testing, have been added to make it more informative. - Section II conveys the information regarding pharmaceutical unit operations and processes. - Section III describes the area of pharmaceutical practice. Extensive recent updates have been included in many chapters of this section. Two new chapters: Parenteral Formulations and New Drug Delivery Systems, have been added. - Section IV contains radioactivity principles and applications. - Section V deals with microbiology and animal products. - Section VI contains the formulation and packaging aspects of pharmaceuticals. Pilot Plant Manufacturing concepts are added as a new chapter, which may be beneficial to readers to understand the art of designing of a plant from the pilot plant model.
The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. Volume five of this publications describes methods and procedures for the quality control of pharmaceutical substances and tablets, tests for dosage forms for suppositories and opthalmic preparations, and a new section on quality control of anti-malarials. Supplementary information on International Chemical Reference Substances and International Reference Spectra, and on the establishment, maintenance and distribution of chemical reference substances are also included.
This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over the last three decades, we have seen the transformation of the pharmaceutical industry and the increasing intricacy of the product life cycle. The challenges we face today are very different from those we faced when the first edition of this Compendium was published in 1997. However, our mission remains the same: to promote health, keep the world safe and serve the vulnerable. The new edition reflects the collective knowledge and expertise of countless professionals who have worked diligently to develop, revise, and implement WHO guidelines for pharmaceuticals. This includes experts from WHO, Member States, our Expert Advisory Panels and Expert Committees on Specifications for Pharmaceutical Preparations and other organizations and has undergone extensive consultation with stakeholders worldwide. This Compendium covers development through manufacturing and quality control to post-marketing surveillance. It provides a comprehensive framework for quality assurance that is both strong and flexible, capable of meeting the requirements of a rapidly changing global health landscape. The 10th edition is a collection of knowledge and tools for empowerment, enabling all stakeholders in the pharmaceutical industry to make informed decisions that prioritize patient safety and well-being.
Over the years, the World Health Organization's Expert Committee on Specifications for Pharmaceutical Preparations, originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control for national regulatory and control systems and the implementation of international standards, but for the most part they have only been available in the annexes to various technical reports. In this second of two volumes, those annexes providing guidelines related to good manufacturing practices and to inspection of manufacturers and drug distribution channels have been gathered and revised. Annotation : 2004 Book News, Inc., Portland, OR (booknews.com).
The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.
