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The Certified Pharmaceutical GMP Professional Handbook, Second Edition

2016-05-26 Business & Economics
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Release : 2016-05-26
Genre : Business & Economics
Kind : eBook
Book Rating : 334/5 ( reviews)

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Book Synopsis The Certified Pharmaceutical GMP Professional Handbook, Second Edition by : Mark Allen Durivage

Download or read book The Certified Pharmaceutical GMP Professional Handbook, Second Edition written by Mark Allen Durivage. This book was released on 2016-05-26. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

The Certified Pharmaceutical GMP Professional Handbook Third Edition

2024-02-28
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Release : 2024-02-28
Genre :
Kind : eBook
Book Rating : 493/5 ( reviews)

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Book Synopsis The Certified Pharmaceutical GMP Professional Handbook Third Edition by : Mark Allen Durivage

Download or read book The Certified Pharmaceutical GMP Professional Handbook Third Edition written by Mark Allen Durivage. This book was released on 2024-02-28. Available in PDF, EPUB and Kindle. Book excerpt:

The GMP Handbook

2017-07-17
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Release : 2017-07-17
Genre :
Kind : eBook
Book Rating : 251/5 ( reviews)

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Book Synopsis The GMP Handbook by : Brendan Cooper

Download or read book The GMP Handbook written by Brendan Cooper. This book was released on 2017-07-17. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Certified Pharmaceutical GMP Professional Handbook

2016-05-23 Technology & Engineering
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Release : 2016-05-23
Genre : Technology & Engineering
Kind : eBook
Book Rating : 909/5 ( reviews)

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Book Synopsis The Certified Pharmaceutical GMP Professional Handbook by : Mark Allen Durivage

Download or read book The Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage. This book was released on 2016-05-23. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

The ASQ CQE Study Guide

2015-11-30 Technology & Engineering
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Release : 2015-11-30
Genre : Technology & Engineering
Kind : eBook
Book Rating : 040/5 ( reviews)

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Book Synopsis The ASQ CQE Study Guide by : Connie M. Borror

Download or read book The ASQ CQE Study Guide written by Connie M. Borror. This book was released on 2015-11-30. Available in PDF, EPUB and Kindle. Book excerpt: This book is primarily meant to aid those taking the ASQ Certified Quality Engineer (CQE) exam and is best used in conjunction with The Certified Quality Engineer Handbook. Section 1 provides 380 practice questions organized by the seven parts of the 2015 Body of Knowledge (BOK). Section 2 gives the reader 205 additional practice questions from each of the seven parts, in a randomized order. For every question in both sections, detailed solutions are provided that explain why each answer is the correct one and also which section of the BOK the question corresponds to so that any further study needed can be focused on specific sections. A secondary audience is those taking exams for ASQ certifications whose BOKs’ have some crossover with the CQE. Namely, the Certified Six Sigma Black Belt (CSSBB), Certified Six Sigma Green Belt (CSSGB), Certified Reliability Engineer (CRE), and Certified Quality Inspector (CQI). Using this guide in studying for any of these exams would be extremely useful, particularly for the statistics portions of the BOKs. Unlike other resources on the market, all these questions and solutions were developed specifically to address the 2015 CQE Body of Knowledge and help those studying for it, including taking into account the proper depth of knowledge and required levels of cognition. None of this material has appeared in any previous resource or been shoehorned into fitting under the BOK’s topics. NOTE: Practice/sample test questions such as those in this study guide cannot be taken into ASQ certification exam rooms.

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