Quality Assurance of Pharmaceuticals

Quality Assurance of Pharmaceuticals PDF

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 PDF

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 PDF

Author: World Health Organization

Publisher:

Published: 2011

Total Pages:

ISBN-13: 9789241548359

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This CD-ROM includes the entire set of current WHO guidelines relating to quality assurance. All guidelines included in this collection have been prepared in consultation with the WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations, with specialists from industry, national institutions, nongovernmental organizations, etc., through a vast global consultative process. The draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, adopted as international standards. This is a comprehensive updated edition of the compendium and it includes all current text most of which were published in the WHO Technical Report Series and in the Vol. 1 and 2 of the printed version of the Quality Assurance of Pharmaceutical Compendium. 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.

Quality Assurance of Pharmaceuticals

Quality Assurance of Pharmaceuticals PDF

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.

Quality Assurance of Pharmaceuticals

Quality Assurance of Pharmaceuticals PDF

Author:

Publisher:

Published: 2013

Total Pages: 0

ISBN-13: 9789241548588

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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, falsified 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. More than 70 relevant documents endorsed by the Committee are reproduced in this CDROM, providing guidance covering all aspects of quality assurance including good manufacturing practices (GMP). This CD-ROM replaces and updates the Compendium of Guidelines and Related Materials published in 2010 and also includes the WHO Training Modules on Good Manufacturing Practices (GMP) study pack with a huge set of training materials reflecting the various GMP texts.

Hugo and Russell's Pharmaceutical Microbiology

Hugo and Russell's Pharmaceutical Microbiology PDF

Author: Brendan F. Gilmore

Publisher: John Wiley & Sons

Published: 2023-01-05

Total Pages: 580

ISBN-13: 1119434556

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Hugo & Russell’s Pharmaceutical Microbiology Discover the very latest developments in pharmaceutical microbiology in the 9th edition of this popular textbook Microbiology is one of the essential pharmaceutical sciences upon which the study and practice of pharmacy is built. It has a bearing on all aspects of the manufacture of medicines and sterile products, from their design and development to their delivery as quality products. Few interventions are more central to modern medicine than the treatment of infection, where antibiosis, vaccination and hygienic practices have essential roles to play. The COVID-19 pandemic, the appearance of new pathogens and the rise of antibiotic resistance have demonstrated most completely the need for pharmaceutical practitioners, researchers and industrial scientists to be fully conversant with this field. The 9th edition of Hugo and Russell’s Pharmaceutical Microbiology has been updated to meet this need. Having long served as the sole comprehensive textbook covering this subject, it has now been adapted to a critical new period in the advancement of medical and pharmaceutical research and development. Its experienced editors have incorporated contributions from subject experts and created a text which will serve the next generation of pharmacy students, pharmaceutical industry scientists and researchers. In this ninth edition of Hugo and Russell’s Pharmaceutical Microbiology, readers will find: A mix of established and new authors bringing practical and research experience to their chapters Material covering the fundamentals of microbiology, microbial behavior and laboratory investigation Revised chapters incorporating new material on microbe-host interactions, antibiotic resistance, emerging pathogens, public health microbiology, healthcare-associated infection and pharmaceutical manufacture Emerging understandings from the COVID-19 pandemic on infection prevention and control and vaccine development Practitioners providing their insights on clinical practice and pharmaceutical production An accompanying website incorporating teaching resources Hugo and Russell’s Pharmaceutical Microbiology, 9th edition promises to remain the essential text for pharmacy and medical students, as well as researchers and industry professionals.

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