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Quality Assurance Of Pharmaceuticals A Compendium Of Guidelines And Related Materials Volume 2 Good Manufacturing Practices And Inspection
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Book Synopsis Quality Assurance of Pharmaceuticals by : World Health Organization
Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by World Health Organization. This book was released on 2004 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).
Book Synopsis Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection by : World Health Organization
Download or read book Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Quality Assurance of Pharmaceuticals by : World Health Organization
Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by World Health Organization. This book was released on 2007 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Quality Assurance Of Pharmaceuticals, Vol. 2, 1/Ed. by : World Health Organization
Download or read book Quality Assurance Of Pharmaceuticals, Vol. 2, 1/Ed. written by World Health Organization and published by . This book was released on 2005 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :WHO Expert Committee on Specifications for Pharmaceutical Preparations Publisher :World Health Organization ISBN 13 :9241209437 Total Pages :173 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Specifications for Pharmaceutical Preparations by : WHO Expert Committee on Specifications for Pharmaceutical Preparations
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations and published by World Health Organization. This book was released on 2007 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance by : World Health Organization
Download or read book Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance written by World Health Organization and published by World Health Organization. This book was released on 2024-10-24 with total page 1788 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations, Third Edition by : Sarfaraz K. Niazi
Download or read book Handbook of Pharmaceutical Manufacturing Formulations, Third Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-11-25 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis WHO Guidelines on Good Agricultural and Collection Practices [GACP] for Medicinal Plants by : World Health Organization
Download or read book WHO Guidelines on Good Agricultural and Collection Practices [GACP] for Medicinal Plants written by World Health Organization and published by World Health Organization. This book was released on 2003-12-16 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The ASQ Certified Pharmaceutical GMP Professional Handbook by : Mark Allen Durivage
Download or read book The ASQ Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2024-09-30 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Herbal Medicinal Products by : Frauke Gaedcke
Download or read book Herbal Medicinal Products written by Frauke Gaedcke and published by CRC Press. This book was released on 2003 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Certified Pharmaceutical GMP Professional Handbook, Second Edition by : Mark Allen Durivage
Download or read book The Certified Pharmaceutical GMP Professional Handbook, Second Edition written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-26 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Quality Assurance of Pharmaceuticals by :
Download or read book Quality Assurance of Pharmaceuticals written by and published by . This book was released on 2007 with total page 409 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by : Tim Sandle
Download or read book Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations by : Sarfaraz K. Niazi
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis The Book of Chinese Medicine, Volume 2 by : Henry H. Sun
Download or read book The Book of Chinese Medicine, Volume 2 written by Henry H. Sun and published by Cambridge Scholars Publishing. This book was released on 2020-11-17 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Quality Control Training Manual by : Syed Imtiaz Haider
Download or read book Quality Control Training Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2016-04-19 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Book Synopsis GMP Audits in Pharmaceutical and Biotechnology Industries by : Mustafa Edik
Download or read book GMP Audits in Pharmaceutical and Biotechnology Industries written by Mustafa Edik and published by CRC Press. This book was released on 2024-06-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
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