Good Manufacturing Practices Gmp Modules For Pharmaceutical Products

Author : Chandrasekhar Panda
Publisher : Pencil
Page : 74 pages
File Size : 47,9 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 : D. Nally Joseph
Publisher : CRC Press
Page : 752 pages
File Size : 47,5 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 : Joseph D. Nally
Publisher : CRC Press
Page : 418 pages
File Size : 44,7 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 : Sidney H. Willig,James R. Stoker
Publisher : Unknown
Page : 520 pages
File Size : 44,5 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 : Graham P. Bunn
Publisher : CRC Press
Page : 371 pages
File Size : 53,6 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 : Anonim
Publisher : Unknown
Page : 0 pages
File Size : 51,9 Mb
Release : 2013
Category : CD-ROMs
ISBN : 9241548584

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Quality Assurance of Pharmaceuticals by Anonim Pdf

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.

Author : Sidney H. Willig
Publisher : CRC Press
Page : 732 pages
File Size : 49,6 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 : 45,5 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 : B. N. Cooper
Publisher : Createspace Independent Publishing Platform
Page : 150 pages
File Size : 53,6 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 : Brendan Cooper
Publisher : Createspace Independent Publishing Platform
Page : 150 pages
File Size : 44,5 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 : Anonim
Publisher : Unknown
Page : 0 pages
File Size : 40,8 Mb
Release : 2000
Category : Drugs
ISBN : OCLC:756531369

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Good Manufacturing Practices for Pharmaceuticals by Anonim Pdf

Author : Sidney H. Willig,Murray M. Tuckerman,William S. Hitchings
Publisher : Unknown
Page : 280 pages
File Size : 52,5 Mb
Release : 1982
Category : Business & Economics
ISBN : UOM:39015002425638

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

Author : S. Iyer
Publisher : Unknown
Page : 128 pages
File Size : 44,8 Mb
Release : 2003-01-01
Category : Electronic
ISBN : 8188513008

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Guidlines On Cgmp And Quality Of Pharmaceutical Products by S. Iyer Pdf

Topics Section I : Basic requirements of GMP Section 2 : Application of GMP & Quality Guidelines for Pharmaceutical Products Section 3 : Revised Schedule M, Part I : Good Manufacturing Practices for Premises and Material's Part II : Requirements of Plant and Equipment Section 4: WHO GMP : Main Principles for Pharmaceutical Products - Quality Management

Author : John Sharp
Publisher : CRC Press
Page : 520 pages
File Size : 52,6 Mb
Release : 2019-08-30
Category : Electronic
ISBN : 0367393778

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Good Pharmaceutical Manufacturing Practice by John Sharp Pdf

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Author : Jordi Botet
Publisher : Bentham Science Publishers
Page : 504 pages
File Size : 42,9 Mb
Release : 2015-09-28
Category : Medical
ISBN : 9781681081144

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Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook by Jordi Botet Pdf

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.