Preface |
|
v | |
Introduction |
|
ix | |
Contributors |
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xvii | |
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1. Regulatory Submissions |
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|
1 | (64) |
|
Patricia Fritz and Anisa Dhalla |
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|
|
2. Compliance Requirements During the Drug Development Process |
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|
65 | (18) |
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|
|
3. Validation: A New Perspective |
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|
83 | (46) |
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|
|
4. Validating Analytical Methods for Pharmaceutical Applications: A Comprehensive Approach |
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|
129 | (56) |
|
Paul A. Winslow and Richard F. Meyer |
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|
|
5. The Stability Testing Program |
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|
185 | (38) |
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6. Computer Validation: A Compliance Focus |
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|
223 | (28) |
|
Timothy Horgan and Timothy Carey |
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|
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7. Compliance Issues Associated with Cleaning in the Pharmaceutical Industry |
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|
251 | (34) |
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8. The Batch Record: A Blueprint for Quality and Compliance |
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285 | (30) |
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|
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9. Change Management: A Far-Reaching, Comprehensive, and Integrated System |
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|
315 | (32) |
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|
10. The Vendor Qualification Program |
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347 | (26) |
|
Elizabeth M. Troll and Karen L. Hughes |
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|
11. Handling Laboratory and Manufacturing Deviations |
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373 | (56) |
|
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12. The Internal Audit Program: A Quality Assessment |
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429 | (34) |
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13. Preapproval Inspections: The Critical Compliance Path to Success |
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463 | (30) |
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Martin D. Hynes III and Carmen Medina |
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14. The Impact of Total Quality Performance on Compliance |
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493 | (60) |
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|
15. International Compliance Issues and Trends |
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553 | (30) |
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|
16. Strategic Planning for Compliance and Regulatory Defensiveness |
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583 | (22) |
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|
17. Unique and Unprecedented Compliance Challenges in the Biologics Arena |
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605 | (42) |
|
Anne P. Hoppe and Curtis L. Scribner |
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Index |
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647 | |