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Sect. A Most suitable environment 1
1 Introduction 3
2 Technology transfer and the climate of change 11
3 Quality systems structure and a maximum quality environment 15
Sect. B Setting process boundaries 29
4 Validation 31
5 Good manufacturing practices 57
6 Process control via numerical means 97
7 Product verification and the role of qualified personnel 111
8 In-process and on-process QC testing and control 119
Sect. C Starting from scratch 131
9 Applications of QA to new medicinal products and new chemical entities formulation 133
10 New products manufacturing 137
11 Questions and problems 151
References 169
Index 177
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