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GMP MANUAL Volume 1 – Manufacturing contains the chapters Production, Packaging, Laboratory and Analytical Control and 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.
Authors:
Dr. Helmut Bender, Dr. Christian Gausepohl, Dr. Ralph Gomez, Dr. Michael Hiob, Dr. Josef Künzle, Paolomi Mukherji, Michael Schulte, Dr. Hanfried Seyfarth, Cornelia Wawretschek
Full table of contents:
GMP MANUAL Volume 1 Manufacturing Contents.pdf
Reading sample:
OOS Form