| Preface |
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ix | |
| Introduction |
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xi | |
| 1 Organization |
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1 | (6) |
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1.1 Structure, Responsibility, and Authority |
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1 | (2) |
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3 | (2) |
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1.3 Emergency Operation Plans |
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5 | (1) |
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1.4 Communication of Concerns |
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5 | (1) |
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6 | (1) |
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1.6 Human Subjects Research |
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6 | (1) |
| 2 Resources |
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7 | (2) |
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7 | (1) |
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7 | (2) |
| 3 Equipment |
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9 | (4) |
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9 | (4) |
| 4 Agreements |
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13 | (11) |
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4.1 Agreement Development and Review |
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13 | (1) |
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13 | (1) |
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4.3 Agreements Relating to Cellular Therapy Products |
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14 | (2) |
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4.4 Educational and Promotional Materials |
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16 | (1) |
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16 | (1) |
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4.6 Obtaining Materials, Products, and Services |
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17 | (2) |
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19 | (1) |
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4.5A Informed Consent for Donors |
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20 | (2) |
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4.5B Informed Consent for Patients |
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22 | (2) |
| 5 Process Control |
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24 | (56) |
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24 | (1) |
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5.2 Process and Procedure Development and Change |
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25 | (2) |
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27 | (1) |
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27 | (3) |
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5.5 Methods and Operational Controls |
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30 | (2) |
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5.6 Product Identification and Traceability |
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32 | (1) |
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5.7 Labels, Labeling, and Labeling Controls |
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33 | (2) |
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5.8 Transport and Shipping |
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35 | (1) |
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5.9 Inspection and Testing |
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36 | (2) |
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5.10 Storage and Preservation |
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38 | (1) |
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39 | (8) |
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5.12 Medical Management and Emergency Care of Donors |
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47 | (2) |
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49 | (1) |
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5.14 Procurement Endpoints |
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50 | (1) |
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51 | (1) |
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51 | (2) |
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5.17 Storage at Processing Facility |
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53 | (2) |
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5.18 Evaluation to Make a Product Available for Distribution |
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55 | (2) |
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57 | (1) |
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58 | (1) |
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59 | (1) |
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5.22 Receipt and Administration of Cellular Therapy Products |
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60 | (1) |
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5.23 Storage at Administering Facility |
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60 | (1) |
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5.24 Preparation for Administration |
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61 | (1) |
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61 | (2) |
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5.26 Postadministration Monitoring |
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63 | (1) |
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64 | (1) |
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5.7.1A Requirements for Labeling of Cellular Therapy Products |
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65 | (3) |
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5.7.1B Requirements for Labeling Shipping Containers |
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68 | (1) |
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5.8.5A Labeling and Packaging Requirements Upon Shipping of Cellular Therapy Products |
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69 | (1) |
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5.11 A General Requirements for Cellular Therapy Product Donors |
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70 | (4) |
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5.11B Clinical Evaluation and Laboratory Testing of Donors |
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74 | (3) |
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5.16A Processing Tests for HPC, Apheresis, and HPC, Marrow |
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77 | (1) |
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5.16B Processing Tests for HPC, Cord Blood Products |
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78 | (1) |
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5.16C Processing Tests for Cellular Therapy Products Other than HPC, Apheresis; HPC, Marrow; and HPC, Cord Blood |
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79 | (1) |
| 6 Documents And Records |
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80 | (13) |
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80 | (1) |
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81 | (3) |
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84 | (2) |
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86 | (7) |
| 7 Deviations And Nonconforming Products Or Services |
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93 | (4) |
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93 | (1) |
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7.2 Control of Nonconforming Products or Services |
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93 | (2) |
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95 | (1) |
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96 | (1) |
| 8 Internal And External Assessments |
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97 | (2) |
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97 | (1) |
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97 | (1) |
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98 | (1) |
| 9 Process Improvement |
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99 | (2) |
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9.1 Corrective and Preventive Action Plans |
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99 | (2) |
| 10 Safety And Facilities |
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101 | (2) |
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101 | (1) |
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10.2 Facilities and Environmental Controls |
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101 | (1) |
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10.3 General Operational Controls |
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102 | (1) |
| Glossary |
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103 | (18) |
| "Crosswalk" Between the Fifth and Sixth Editions of CT Standards |
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121 | (6) |
| Index |
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127 | |
