| Preface | | iii | |
| Introduction | | ix | |
| Status and Applicability of U.S. Regulatins: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holdings of Drugs |
| | 1 | (15) |
| Finished Pharmaceuticals: General Provisions (Subpart A) |
| | 16 | (14) |
| Organization and Personnel (Subpart B) |
| | 30 | (13) |
| Buildings and Facilities (Subpart C) |
| | 43 | (22) |
| | 65 | (16) |
| Control of Components and Drug Product Containers and Closures (Subpart E) |
| | 81 | (18) |
| Production and Process Controls (Subpart F) |
| | 99 | (40) |
| Packaging and Labeling Controls (Subpart G) |
| | 139 | (34) |
| Holding and Distribution (Subpart H) |
| | 173 | (4) |
| Laboratory Controls (Subpart I) |
| | 177 | (32) |
| Records and Reports (Subpart J) |
| | 209 | (27) |
| Returned and Salvaged Drug Products (Subpart K) |
| | 236 | (6) |
| | 242 | (14) |
| Bulk Pharmaceutical Chemicals |
| | 256 | (17) |
| The Pharmacist and Total Quality Control |
| | 273 | (28) |
| Recalls and CGMPs: Enforcement Alternatives in the United States |
| | 301 | (16) |
| Controlled Substances Safeguards (21 CFR 1300, et seq.) |
| | 317 | (4) |
| The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected; The Rationale for Inspection (21 USC 373, 374) |
| | 321 | (46) |
| FDA Pre-Approval Inspections/Investigations; The Road from SUPAC to the Food and Drug Modernization Act |
| | 367 | (12) |
| Who Is the Manufacturer? Some Additional Considerations for the Multinational |
| | 379 | (10) |
| | 389 | (19) |
| Other Approaches to Quality |
| | 408 | (17) |
| Import and Export of Pharmaceuticals and Other Products Subject to CGMPs |
| | 425 | (13) |
| Enhancement of Global Product Distribution |
| | 438 | (15) |
| Appendix A Food and Drug Modernization Act of 1997---in Pertinent Part | | 453 | (95) |
| Appendix B Components/Repackagers | | 548 | (65) |
| Appendix C Hearing Procedures When FDA Proposes the Imposition of Civil Money Penalties | | 613 | (49) |
| Appendix D Section 601.12 Changes Currently Considered ``Important'' by CBER | | 662 | (29) |
| Appendix E USP24--NF19 Information; Monographs; Tests; Assays | | 691 | (28) |
| Index | | 719 | |
