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
Page : 250 pages
File Size : 54,7 Mb
Release : 2004
Category : Business & Economics
ISBN : 9241546190

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Quality Assurance of Pharmaceuticals by World Health Organization Pdf

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).

Author : World Health Organization
Publisher : World Health Organization
Page : 1354 pages
File Size : 40,5 Mb
Release : 2024-01-31
Category : Business & Economics
ISBN : 9789240086081

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Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection by World Health Organization Pdf

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.

Author : World Health Organization
Publisher : Unknown
Page : 236 pages
File Size : 54,9 Mb
Release : 2005
Category : Electronic
ISBN : 8174732853

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Quality Assurance Of Pharmaceuticals, Vol. 2, 1/Ed. by World Health Organization Pdf

Author : Anonim
Publisher : Unknown
Page : 409 pages
File Size : 41,8 Mb
Release : 2007
Category : Drugs
ISBN : OCLC:290514493

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Quality Assurance of Pharmaceuticals by Anonim Pdf

Author : World Health Organization
Publisher : Unknown
Page : 202 pages
File Size : 43,5 Mb
Release : 1999-01-01
Category : Drugs
ISBN : 9241545267

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Quality Assurance of Pharmaceuticals by World Health Organization Pdf

Specialized good manufacturing practice (GMP) guidelines for the manufacture of herbal medicinal products address manufacture of products from material of plant origin, which may be subject to contamination and deterioration and may vary in its composition and properties. Furthermore, procedures and techniques often used in the manufacture and quality control of herbal medicines, are substantially different from those used for conventional pharmaceutical products. These specialized GMP guidelines were adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its Thirty-fourth meeting and supplement the existing WHO core GMP guidelines. These guidelines were subsequently published in Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials, Volume 2, Good manufacturing practices and inspection. This publication reproduces guidelines related to good manufacturing practices (GMP) and to the inspection of pharmaceutical manufacturing and drug distribution channels. Provides guidance covering all aspects of good manufacturing practices and includes important texts on inspection.

Author : World Health Organization
Publisher : World Health Organization
Page : 414 pages
File Size : 40,7 Mb
Release : 2007
Category : Business & Economics
ISBN : 9789241547086

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Quality Assurance of Pharmaceuticals by World Health Organization Pdf

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.

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 50,5 Mb
Release : 1997
Category : Electronic
ISBN : LCCN:00330010

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Quality assurance of pharmaceuticals by Anonim Pdf

Author : WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization
Publisher : World Health Organization
Page : 173 pages
File Size : 46,9 Mb
Release : 2007
Category : Business & Economics
ISBN : 9789241209434

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WHO Expert Committee on Specifications for Pharmaceutical Preparations by WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization Pdf

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.

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 574 pages
File Size : 45,7 Mb
Release : 2019-11-25
Category : Medical
ISBN : 9781351593595

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition by Sarfaraz K. Niazi Pdf

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

Author : Organización Mundial de la Salud,World Health Organization,WHO
Publisher : World Health Organization
Page : 81 pages
File Size : 46,7 Mb
Release : 2003-12-16
Category : Business & Economics
ISBN : 9789241546270

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WHO Guidelines on Good Agricultural and Collection Practices [GACP] for Medicinal Plants by Organización Mundial de la Salud,World Health Organization,WHO Pdf

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.

Author : Frauke Gaedcke,Barbara Steinhoff
Publisher : CRC Press
Page : 208 pages
File Size : 49,7 Mb
Release : 2003
Category : Health & Fitness
ISBN : 0849310237

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Herbal Medicinal Products by Frauke Gaedcke,Barbara Steinhoff Pdf

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.

Author : Mark Allen Durivage
Publisher : Quality Press
Page : 404 pages
File Size : 44,9 Mb
Release : 2016-05-23
Category : Technology & Engineering
ISBN : 9781951058906

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The Certified Pharmaceutical GMP Professional Handbook by Mark Allen Durivage Pdf

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Author : Tim Sandle
Publisher : Elsevier
Page : 370 pages
File Size : 45,5 Mb
Release : 2013-10-31
Category : Medical
ISBN : 9781908818638

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Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by Tim Sandle Pdf

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 386 pages
File Size : 42,6 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420081220

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Handbook of Pharmaceutical Manufacturing Formulations by Sarfaraz K. Niazi Pdf

Providing methodologies that can serve as a reference point for new formulations, the second volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products.Highlights from Uncompressed Solid Products, Volume Two include:the fundamental issues of good manufacturin

Author : Henry H. Sun,Jingyan Meng,Kaijing Yan
Publisher : Cambridge Scholars Publishing
Page : 700 pages
File Size : 55,8 Mb
Release : 2020-11-17
Category : Medical
ISBN : 9781527562356

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The Book of Chinese Medicine, Volume 2 by Henry H. Sun,Jingyan Meng,Kaijing Yan Pdf

This second volume offers numerous approaches to using Chinese medicine for the prevention and treatment of various diseases in medical practice. It brings the concepts and theories learned in the first volume and applies them in clinical settings with real patient examples. It goes over the four natures and five flavors of herbal drugs, and covers the different techniques of acupuncture. The book considers how the advancements in modern technology have shaped Traditional Chinese Medicine (TCM), and discusses the revolutionary innovations that are occurring in the Chinese medicine industry today and how they will shape the future.