Current Good Manufacturing Practices

Author : José Rodríguez-Pérez
Publisher : Quality Press
Page : 396 pages
File Size : 49,8 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 : Manohar A Potdar,Ramkumar Dubey
Publisher : Pharmamed Press
Page : 856 pages
File Size : 42,6 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 : Mindy J. Allport-Settle
Publisher : PharmaLogika Books
Page : 688 pages
File Size : 44,8 Mb
Release : 2018-02-20
Category : Reference
ISBN : 1937258173

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Current Good Manufacturing Practices by Mindy J. Allport-Settle Pdf

FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR§11) and Guidance for Industry - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community (21CFR§26) - Part 200 Drugs: General (21CFR§200) - Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and The National Drug Code (21CFR§207) - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (21CFR§210) - Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (21CFR§211) - Part 600 Biological Products: General (21CFR§600) - Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (21CFR§807) - Part 820 Quality System Regulation (21CFR§820) - Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry and FD A Staff: Current Good Manufacturing Practice Requirements for Combination Products - Guidance for Industry: CGMP for Phase 1 Investigational Drugs - Process Validation: General Principles and Practices - PAT - A Frame work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance - Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations - Contract Manufacturing Arrangements for Drugs: Quality Agreements - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - Formal Dispute Resolution: Sponsor Appeals Above the Division Level Reference Tools: - Glossaries combined in one location - GMP Keyword Index for 21CFR211 - Combined Index for all documents

Author : Graham P. Bunn
Publisher : CRC Press
Page : 371 pages
File Size : 47,8 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 : Joseph D. Nally
Publisher : CRC Press
Page : 424 pages
File Size : 47,7 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 : Terry Jacobs,Andrew A. Signore
Publisher : CRC Press
Page : 535 pages
File Size : 42,9 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 : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 857 pages
File Size : 43,6 Mb
Release : 2008-04-04
Category : Science
ISBN : 9780470259825

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Pharmaceutical Manufacturing Handbook by Shayne Cox Gad Pdf

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

Author : B. N. Cooper
Publisher : Createspace Independent Publishing Platform
Page : 150 pages
File Size : 46,7 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 : José (Pepe) Rodríguez-Pérez
Publisher : Quality Press
Page : 260 pages
File Size : 43,9 Mb
Release : 2014-04-30
Category : Business & Economics
ISBN : 9780873898294

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

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. 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. As a bonus, this package contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for GMP audit is also included based on risk management criteria. An exam complements the extra material.

Author : Brendan Cooper
Publisher : Createspace Independent Publishing Platform
Page : 150 pages
File Size : 49,6 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 : 4 pages
File Size : 43,6 Mb
Release : 1981
Category : Food
ISBN : MINN:319510028869770

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Federal Food Standards by Anonim Pdf

Author : John Sharp
Publisher : CRC Press
Page : 520 pages
File Size : 40,6 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 : Jack O'Grady
Publisher : Unknown
Page : 207 pages
File Size : 44,8 Mb
Release : 2021-02-16
Category : Electronic
ISBN : 9798709514119

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Quality Assurance and Regulatory Affairs for the Biosciences by Jack O'Grady Pdf

A solid and attractive book to learn. More than a compilation book of standards and techniques, this book provides a real and clear guide to learning about quality assurance and regulatory issues of pharmaceutical, biomedical and biotechnological products. In this short book, Jack O'Grady introduces dynamically and consistently the topics of greatest interest to the reader. Also, a series of links to the web pages of the relevant institutions (eg manuals, guides, statistics) is provided through scannable QR codes, thus granting a greater utility to the reader and reducing redundant and technical content to make reading more agile and productive. Table of Contents: Chapter 1. Introduction to Biotechnology and Quality Assurance. Chapter 2. Introduction to Quality Principles Chapter 3. Quality Management Systems Chapter 4. The Food and Drug Administration Chapter 5. Good Guidance Practices (GXPs) Chapter 6. The Drug Approval Process Chapter 7. The Regulation of Biologics Chapter 8. Medical Device and Combination Products Chapter 9. Regulation of Food and Other Products Chapter 10. FDA Enforcement ⚠ Before purchasing this book, consider: This book is not designed for experts in the field, as it may fall into the basics. This book is not a compendium of regulations but provides links to find them on the websites of the relevant institutions. This book does not compile analytical laboratory techniques. Instead, it explains the management of quality standards and management of product quality at the corporate level. This book is short and does not provide an exhaustive discussion of all the topics, however, it does provide a solid basis for the reader to delve into his interests.

Author : Sidney H. Willig
Publisher : CRC Press
Page : 732 pages
File Size : 45,9 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 : Emmet P. Tobin
Publisher : Createspace Independent Publishing Platform
Page : 72 pages
File Size : 49,5 Mb
Release : 2016-04-16
Category : Electronic
ISBN : 1532702124

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Cgmp Starter Guide by Emmet P. Tobin Pdf

This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP). It introduces those who wish to work in regulated industries to GMP, highlighting key areas and practices. It is also a useful refresher for those with previous experience of cGMP.