The Certified Pharmaceutical GMP Professional Handbook Third Edition
Title | The Certified Pharmaceutical GMP Professional Handbook Third Edition PDF eBook |
Author | Mark Allen Durivage |
Publisher | |
Pages | 0 |
Release | 2024-02-28 |
Genre | Business & Economics |
ISBN | 9781636941493 |
The Certified Pharmaceutical GMP Professional Handbook, Second Edition
Title | The Certified Pharmaceutical GMP Professional Handbook, Second Edition PDF eBook |
Author | Mark Allen Durivage |
Publisher | Quality Press |
Pages | 386 |
Release | 2016-05-26 |
Genre | Business & Economics |
ISBN | 0873899334 |
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 Certified Pharmaceutical GMP Professional Handbook
Title | The ASQ Certified Pharmaceutical GMP Professional Handbook PDF eBook |
Author | Mark Allen Durivage |
Publisher | Quality Press |
Pages | 421 |
Release | 2024-09-30 |
Genre | Technology & Engineering |
ISBN | 1636941516 |
The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.
The GMP Handbook
Title | The GMP Handbook PDF eBook |
Author | Brendan Cooper |
Publisher | Createspace Independent Publishing Platform |
Pages | 150 |
Release | 2017-07-17 |
Genre | |
ISBN | 9781548370251 |
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 Biomedical Quality Auditor Handbook, Third Edition
Title | The Biomedical Quality Auditor Handbook, Third Edition PDF eBook |
Author | Heather Crawford |
Publisher | Quality Press |
Pages | 271 |
Release | 2017-09-08 |
Genre | Business & Economics |
ISBN | 0873899628 |
The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQs Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
Pharmaceutical Manufacturing Handbook
Title | Pharmaceutical Manufacturing Handbook PDF eBook |
Author | Shayne Cox Gad |
Publisher | John Wiley & Sons |
Pages | 1384 |
Release | 2008-03-21 |
Genre | Science |
ISBN | 0470259809 |
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.
Good Manufacturing Practices for Pharmaceuticals
Title | Good Manufacturing Practices for Pharmaceuticals PDF eBook |
Author | B. N. Cooper |
Publisher | Createspace Independent Publishing Platform |
Pages | 150 |
Release | 2017-07-26 |
Genre | |
ISBN | 9781974006328 |
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