Quality Assurance of Pharmaceuticals
Quality Assurance of Pharmaceuticals

Author: World Health Organization

Publisher: World Health Organization

Published: 2004

Total Pages: 250

ISBN-13: 9789241546195

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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).

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection

Author: World Health Organization

Publisher: World Health Organization

Published: 2024-01-31

Total Pages: 1354

ISBN-13: 9240086080

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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.

Quality Assurance of Pharmaceuticals
Quality Assurance of Pharmaceuticals

Author: World Health Organization

Publisher: World Health Organization

Published: 2007

Total Pages: 414

ISBN-13: 9241547081

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Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.

WHO Expert Committee on Specifications for Pharmaceutical Preparations
WHO Expert Committee on Specifications for Pharmaceutical Preparations

Author: WHO Expert Committee on Specifications for Pharmaceutical Preparations

Publisher: World Health Organization

Published: 2007

Total Pages: 173

ISBN-13: 9241209437

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This report sets out the recommendations of an international group of experts relating to developments in the quality assurance of medicines and specifications for drug substances and dosage forms. It contains guidelines of direct relevance to the UN Prequalification Programme for Priority Essential Medicines and for quality control laboratories, including procedures governing the assessment of pharmaceutical products for procurement by UN agencies and for assessing the acceptability of quality control laboratories. It also includes discussion regarding several monographs for inclusion in the International Pharmacopoeia, relating to antiretrovirals, including fixed-dose combinations, TB medicines and antimalarial and paediatric medicines.

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance

Author: World Health Organization

Publisher: World Health Organization

Published: 2024-10-24

Total Pages: 1788

ISBN-13: 9240099425

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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.

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Author: Sarfaraz K. Niazi

Publisher: CRC Press

Published: 2019-11-25

Total Pages: 602

ISBN-13: 1351593595

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The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

WHO Guidelines on Good Agricultural and Collection Practices [GACP] for Medicinal Plants
WHO Guidelines on Good Agricultural and Collection Practices [GACP] for Medicinal Plants

Author: World Health Organization

Publisher: World Health Organization

Published: 2003-12-16

Total Pages: 81

ISBN-13: 9241546271

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Medicinal plant materials are supplied through collection from wild populations and cultivation. Under the overall context of quality assurance and control of herbal medicines WHO developed the Guidelines on good agricultural and collection practices (GACP) for medicinal plants providing general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines. These guidelines are also related to WHO's work on the protection of medicinal plants aiming promotion of sustainable use and cultivation of medicinal plants. The main objectives of these guidelines are to: (1) contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality safety and efficacy of finished herbal products; (2) guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and (3) encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general. These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations. Good agricultural and collection practices for medicinal plants are the first step in quality assurance on which the safety and efficacy of herbal medicinal products directly depend. These practices also play an important role in protection natural resources of medicinal plants for sustainable use.

The ASQ Certified Pharmaceutical GMP Professional Handbook
The ASQ Certified Pharmaceutical GMP Professional Handbook

Author: Mark Allen Durivage

Publisher: Quality Press

Published: 2024-09-30

Total Pages: 421

ISBN-13: 1636941516

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The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.

Herbal Medicinal Products
Herbal Medicinal Products

Author: Frauke Gaedcke

Publisher: CRC Press

Published: 2003

Total Pages: 208

ISBN-13: 9780849310232

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Herbal medicinal products are becoming more widely accepted as alternatives to medical prescriptions. Many physicians believe that herbal medicinal products are able to beneficially complement or even replace chemical medicines. Recognizing this, European institutions are pushing the harmonization of assessment criteria for herbal medicinal products. However, this kind of reevaluation of herbal medicinal products is combined with increased expectations of physicians, pharmacists, and patients with regard to quality, safety and efficacy. There are often uncertainties about the interpretation of basic terms related to the manufacture and quality of herbal medicinal products. Herbal Medicinal Products clarifies these uncertainties, increasing transparency in the herbal medicinal products market and supporting an adequate scientific discussion related to herbal medicinal products. It offers a complete survey on current scientific knowledge, as well as on legal basic requirements for the development, standardization, and licensing of herbal medicinal products.