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1.B The road to a pharmaceutical quality system
Extract: 7.A Process Validation - Official Requirements
Extract: 18.H Questionnaire for preparing GMP inspections
19.B.3 The qualified person - Qualification and Experience
21.A.11 GMP for APIs - Laboratory Controls
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GMP MANUAL Volume 1 Manufacturing
Excerpt from the GMP MANUAL
620 Seiten
Format: DIN A4
ISBN: 978-3-934971-74-5
Format: DIN A4
ISBN: 978-3-934971-74-5
€ 175,00
netto
€ 187,25
inkl. 7% MwSt.
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GMP MANUAL Volume 1 – Manufacturing contains the chapters
- Production
- Packaging
- Laboratory and Analytical Control
- Documentation
from the comprehensive reference work GMP MANUAL. It is intended to support staff in the pharmaceutical production field by providing internationally accepted GMP guidance. In this book, international GMP experts share their knowledge of GMP implementation according to GMP regulations of the FDA, Europe, ICH, PIC/S and WHO. You’ll learn how noted industry specialists solve the quality challenges in their companies, and improve and fine-tune your procedures accordingly. You will receive answers to quality related questions that affect your daily business.
Full table of contents:
GMP MANUAL Volume 1 Manufacturing Contents.pdf
- Production
- Packaging
- Laboratory and Analytical Control
- Documentation
from the comprehensive reference work GMP MANUAL. It is intended to support staff in the pharmaceutical production field by providing internationally accepted GMP guidance. In this book, international GMP experts share their knowledge of GMP implementation according to GMP regulations of the FDA, Europe, ICH, PIC/S and WHO. You’ll learn how noted industry specialists solve the quality challenges in their companies, and improve and fine-tune your procedures accordingly. You will receive answers to quality related questions that affect your daily business.
Full table of contents:
GMP MANUAL Volume 1 Manufacturing Contents.pdf
Dr. Helmut Bender, Dr. Christian Gausepohl, Dr. Ralph Gomez, Dr. Michael Hiob, Dr. Josef Künzle, Paolomi Mukherji, Michael Schulte, Dr. Hanfried Seyfarth, Cornelia Wawretschek
