The Elements and Philosophy of Pharmaceutical Quality Assurance PDF Download

Author: Pharmaceutical Quality Group
Publisher:
ISBN: 9780906810248
Category : Pharmaceutical industry
Languages : en
Pages : 18

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Author: Institute of Quality Assurance
Publisher: Twayne Publishers
ISBN: 9780906810781
Category : Chemical engineering
Languages : en
Pages : 24

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Book Description

Author: Minal Ghante
Publisher: Springer Nature
ISBN: 9819992710
Category :
Languages : en
Pages : 525

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Author: Anjaneyulu Marayya
Publisher:
ISBN: 9788188449149
Category : Business & Economics
Languages : en
Pages : 0

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Book Description
QA is the most vital function of Total Quality Management (TQM) in pharmaceutical industry. This book presents the basic concepts on various topics like QMS, GLP, GMP, Quality Audit, Statistical Quality Control and analytica methods for QA. The elements, requirement and interpretation of ISO 9000 series of QMS are presented in detail.

Author: Oliver Schmidt
Publisher: CRC Press
ISBN: 142002602X
Category : Medical
Languages : en
Pages : 392

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Book Description
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547081
Category : Business & Economics
Languages : en
Pages : 414

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Book Description
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: Charles P. Coe
Publisher: American Society of Health-System Pharmacists
ISBN:
Category : Hospital pharmacies
Languages : en
Pages : 316

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Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241546195
Category : Business & Economics
Languages : en
Pages : 250

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Book Description
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: Mr. Manohar A. Potdar
Publisher: Pragati Books Pvt. Ltd.
ISBN: 9788185790596
Category : Pharmaceutical industry
Languages : en
Pages : 424

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Book Description

Author: Jordi Botet
Publisher: Bentham Science Publishers
ISBN: 1681081148
Category : Medical
Languages : en
Pages : 504

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Book Description
Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.