Foreword Requirement specifications are part of a documentation of GMP validation/qualification. In order to meet the GMP requirements from URS (DRS, TRS, FRS) in a pharmaceutical project according to GMP/FDA re-quirements, the specifications should be designed and created according to GDP (Good Documentation Practice). A profes-sionally prepared GMP order can minimize problems with later validation/Qualification. With this book I would like to teach you the structure concept, components and the creation of a professional ...
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Foreword Requirement specifications are part of a documentation of GMP validation/qualification. In order to meet the GMP requirements from URS (DRS, TRS, FRS) in a pharmaceutical project according to GMP/FDA re-quirements, the specifications should be designed and created according to GDP (Good Documentation Practice). A profes-sionally prepared GMP order can minimize problems with later validation/Qualification. With this book I would like to teach you the structure concept, components and the creation of a professional GMP order specifica-tion and functional specification. Of course, the expertise from this book can also be used in other industrial sectors such as aerospace technologies or electronic engineering. Have fun and congratulations for your endeavor and project. Your Parviz Bayegi
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