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 ManagementChapter 3-PersonnelChapter 4-Buildings and FacilitiesChapter 5-Process EquipmentChapter 6-Documentation and RecordsChapter 7-Materials ManagementChapter 8-Rejection and re-use of materialsChapter 9-ValidationChapter 10- Change Control Chapter 11-Complaints and recallsPage count 160. Paperback book. Large 8" x 10" format.
✔ Author(s): Brendan Cooper
✔ Title: The GMP Handbook: A Guide to Quality and Compliance
✔ Rating : 3.7 out of 5 base on (22 reviews)
✔ ISBN-10: 1548370258
✔ ISBN-13: 9781548370251
✔ Language: English
✔ Format ebook: PDF, EPUB, Kindle, Audio, HTML and MOBI
✔ Device compatibles: Android, iOS, PC and Amazon Kindle
Readers' opinions about The GMP Handbook by Brendan Cooper
Jillian Neel
I loved the powerful messages hidden within the story. The book tackled important social issues and made me ponder the world we live in. It's a must-read for everyone.
Melody Blake
The plot was incredibly well-crafted, with twists and turns that kept me hooked until the very last page. It was impossible to predict what would happen next.
Sydney Richardson
The characters in this book felt like old friends, and I was sad to say goodbye to them at the end. It's a testament to the author's talent for creating memorable and relatable personas.
