GMP in Practice, 4th Edition is intended to help with that harmonization. In it, we will look at more than 30 elements that are typically included in a modern pharmaceutical quality system. Each quality system element has an overview section, some risk-related questions, and 3-10 expectations. Each expectation is explored in a bit more detail and examples from GMP references from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH) are presented.
In order to get a rich understanding of GMP, a person needs to have knowledge of what various national authorities expect. This book is designed to help you achieve this goal.
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