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Book Categories |
Preface | ||
Contributors | ||
1 | Organization of quality assurance | 1 |
2 | Coming into GMP compliance | 15 |
3 | Documentation system | 27 |
4 | Validation | 45 |
5 | Quality assurance (QA) of production materials for biotechnology | 61 |
6 | Quality assurance (QA) of analytical methods - biochemical | 75 |
7 | Applied data analysis, sampling methodologies, and statistical validation techniques | 91 |
8 | Environmental and safety programs for biotechnology | 119 |
9 | Regulatory issues - United States | 137 |
10 | Regulatory issues - Europe | 151 |
11 | Regulatory issues - Japan | 171 |
Abbreviations | 189 | |
Appendices | 193 | |
Index | 197 |
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Add Quality Assurance For Biopharmaceuticals, Provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies. Discusses what systems are needed along with a descript, Quality Assurance For Biopharmaceuticals to the inventory that you are selling on WonderClubX
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Add Quality Assurance For Biopharmaceuticals, Provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies. Discusses what systems are needed along with a descript, Quality Assurance For Biopharmaceuticals to your collection on WonderClub |