Good Manufacturing Practices For Pharmaceuticals

Author : Graham P. Bunn
Publisher : CRC Press
Page : 371 pages
File Size : 52,8 Mb
Release : 2019-02-04
Category : Medical
ISBN : 9781498732079

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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition by Graham P. Bunn Pdf

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.

Author : Sidney H. Willig,James R. Stoker
Publisher : Unknown
Page : 520 pages
File Size : 40,9 Mb
Release : 1997
Category : Business & Economics
ISBN : UOM:39015038568302

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Good Manufacturing Practices for Pharmaceuticals by Sidney H. Willig,James R. Stoker Pdf

Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity.

Author : Joseph D. Nally
Publisher : CRC Press
Page : 418 pages
File Size : 44,9 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420020939

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Good Manufacturing Practices for Pharmaceuticals by Joseph D. Nally Pdf

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.

Author : D. Nally Joseph
Publisher : CRC Press
Page : 752 pages
File Size : 48,8 Mb
Release : 2000-10-12
Category : Medical
ISBN : 9780824741938

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Good Manufacturing Practices for Pharmaceuticals by D. Nally Joseph Pdf

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.

Author : José Rodríguez-Pérez
Publisher : Quality Press
Page : 246 pages
File Size : 51,6 Mb
Release : 2014-08-15
Category : Business & Economics
ISBN : 9780873898690

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The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals by José Rodríguez-Pérez Pdf

This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.

Author : Sidney H. Willig
Publisher : CRC Press
Page : 732 pages
File Size : 54,6 Mb
Release : 2001
Category : Medical
ISBN : 0824704258

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Good Manufacturing Practices for Pharmaceuticals by Sidney H. Willig Pdf

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.

Author : World Health Organization
Publisher : World Health Organization
Page : 250 pages
File Size : 45,8 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 : Sidney H. Willig,Murray M. Tuckerman,William S. Hitchings
Publisher : Unknown
Page : 320 pages
File Size : 41,6 Mb
Release : 1982
Category : Drugs
ISBN : UCAL:B5040866

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Good Manufacturing Practices for Pharmaceuticals by Sidney H. Willig,Murray M. Tuckerman,William S. Hitchings Pdf

Author : Manohar A Potdar,Ramkumar Dubey
Publisher : Pharmamed Press
Page : 856 pages
File Size : 54,5 Mb
Release : 2019-07
Category : Medical
ISBN : 9387593444

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CGMP Current Good Manufacturing Practices for Pharmaceuticals by Manohar A Potdar,Ramkumar Dubey Pdf

Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written in simple and easy to implement manner.

Author : B. N. Cooper
Publisher : Createspace Independent Publishing Platform
Page : 150 pages
File Size : 45,9 Mb
Release : 2017-07-26
Category : Electronic
ISBN : 1974006328

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Good Manufacturing Practices for Pharmaceuticals by B. N. Cooper Pdf

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

Author : Chandrasekhar Panda
Publisher : Pencil
Page : 74 pages
File Size : 48,7 Mb
Release : 2021-06-24
Category : Social Science
ISBN : 9789354583049

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Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products by Chandrasekhar Panda Pdf

This Book contains 11 Modules of Good Manufacturing Practices (GMP) for Pharmaceutical Products which will be very useful to the persons working in Pharmaceutical Industry and this can be used as a cGMP Training modules in Pharmaceutical Companies which is a basic training requirement for every employee. The Modules are Module-1 Plant Premises Module-2 Plant Equipment's Module-3 Plant Production Module-4 Plant Personnel Module-5 Plant Training, Documentation and Personnel Hygiene Module-6 Plant Quality Control Module-7 Qualification and Validation Module-8 Pharmaceutical QMS Module-9 Plant Self-Inspection and Audit Module-10 Plant Complaints and Product recall Module-11 Plant Contract Manufacturing and Contract Analysis

Author : Brendan Cooper
Publisher : Createspace Independent Publishing Platform
Page : 150 pages
File Size : 55,8 Mb
Release : 2017-07-17
Category : Electronic
ISBN : 1548370258

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The GMP Handbook by Brendan Cooper Pdf

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.

Author : Terry Jacobs,Andrew A. Signore
Publisher : CRC Press
Page : 535 pages
File Size : 54,8 Mb
Release : 2016-08-19
Category : Medical
ISBN : 9781482258912

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Good Design Practices for GMP Pharmaceutical Facilities by Terry Jacobs,Andrew A. Signore Pdf

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.

Author : Sidney Willig
Publisher : CRC Press
Page : 752 pages
File Size : 55,8 Mb
Release : 2000-10-12
Category : Technology & Engineering
ISBN : 1135568138

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Good Manufacturing Practices for Pharmaceuticals by Sidney Willig Pdf

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 recommends pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. It focuses 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.

Author : William J. Mead
Publisher : CRC Press
Page : 314 pages
File Size : 51,6 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420077414

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Dietary Supplement Good Manufacturing Practices by William J. Mead Pdf

Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products.The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances-leaving implementati