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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

Author : Graham P. Bunn

Publisher : CRC Press

Page : 387 pages

File Size : 48,73 MB

Release : 2019-02-04

Category : Medical

ISBN : 1498732070

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Book Description

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry



Good Manufacturing Practices for Pharmaceuticals

Author : Joseph D. Nally

Publisher : CRC Press

Page : 418 pages

File Size : 20,41 MB

Release : 2016-04-19

Category : Medical

ISBN : 1420020935

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Book Description

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.



Good Manufacturing Practices for Pharmaceuticals

Author : Sidney H. Willig

Publisher : CRC Press

Page : 732 pages

File Size : 45,22 MB

Release : 2001

Category : Medical

ISBN : 9780824704254

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Book Description

This book examines United States law and governmental policy affecting domestic and multinational pharmaceutical manufacturing, recommending pragmatic ways to interpret and comply with FDA current good manufacturing practice (CGMP) regulation and related criteria.



Good Manufacturing Practices for Pharmaceuticals

Author : D. Nally Joseph

Publisher : CRC Press

Page : 752 pages

File Size : 12,55 MB

Release : 2000-10-12

Category : Medical

ISBN : 0824741935

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Book Description

Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.



Good Design Practices for GMP Pharmaceutical Facilities

Author : Terry Jacobs

Publisher : CRC Press

Page : 535 pages

File Size : 41,75 MB

Release : 2016-08-19

Category : Medical

ISBN : 1482258919

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Book Description

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.



Good Manufacturing Practices for Pharmaceuticals

Author : B. N. Cooper

Publisher : Createspace Independent Publishing Platform

Page : 150 pages

File Size : 40,44 MB

Release : 2017-07-26

Category :

ISBN : 9781974006328

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Book Description

CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format



Introduction to Market Access for Pharmaceuticals

Author : Mondher Toumi

Publisher : CRC Press

Page : 310 pages

File Size : 14,3 MB

Release : 2017-01-12

Category : Medical

ISBN : 1315314584

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Book Description

Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University. Key Features: The first guide to market access for pharmaceuticals based on tested teaching materials Addresses both pharmaceutical and vaccine products Includes case studies and scenarios Covers market access consdierations for Western Europe, the USA, Japan and China Explains the impact the changing healthcare market will have on your product



Hugo and Russell's Pharmaceutical Microbiology

Author : Stephen P. Denyer

Publisher : John Wiley & Sons

Page : 494 pages

File Size : 26,30 MB

Release : 2008-04-15

Category : Medical

ISBN : 1405141034

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Book Description

Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist "....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students." Journal of Antimicrobial Chemotherapy ".....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index." Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes



Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad

Publisher : John Wiley & Sons

Page : 1386 pages

File Size : 46,78 MB

Release : 2008-03-11

Category : Science

ISBN : 0470259809

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Book Description

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.



The GMP Handbook

Author : Brendan Cooper

Publisher : Createspace Independent Publishing Platform

Page : 150 pages

File Size : 26,3 MB

Release : 2017-07-17

Category :

ISBN : 9781548370251

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Book Description

CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.