Active pharmaceutical ingredients: development, manufacturing, and regulation
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Boca Raton, Fla.
Taylor & Francis
2005
|
| Schriftenreihe: | Drugs and the pharmaceutical sciences
151 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XIV, 337 S. Ill. |
| ISBN: | 082470293X |
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| 650 | 4 | |a Techniques pharmaceutiques | |
| 650 | 4 | |a Recht | |
| 650 | 4 | |a Drug development | |
| 650 | 4 | |a Pharmaceutical technology | |
| 650 | 4 | |a Drugs |x Law and legislation | |
| 650 | 4 | |a Pharmaceutical industry | |
| 650 | 4 | |a Drug Industry |x organization & administration | |
| 650 | 4 | |a Chemistry, Pharmaceutical | |
| 650 | 4 | |a Drug Compounding | |
| 650 | 4 | |a Legislation, Drug | |
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Datensatz im Suchindex
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|---|---|
| adam_text | **, O *** * ACTIVE PHARMACEUTICAL INGREDIENTS DEVELOPMENT,
MANUFACTURING, AND REGULATION EDITED BY STANLEY H. NUSIM 5. H. NUSIM
ASSOCIATES, INC. AVENTURA, FLORIDA, U.S.A. TAYLOR & FRANCIS TAYLOR 6
FRANCIS CROUP BOCA RATON LONDON NEW YORK SINGAPORE CONTENTS PREFACE ....
HI CONTRIBUTORS .... XIII 1. INTRODUCTION L STANLEY H. NUSIM I.
CONSOLIDATION AND INTEGRATION .... 2 II. QUALITY .... 2 III. POTENCY
.... 5 IV. COMPUTER CONTROL AND AUTOMATION .... 6 V. SUMMARY .... 7 2.
PROCESS DEVELOPMENT 9 CARLOS B. ROSAS I. INTRODUCTION .... 9 II. THE
BULK DRUG PROCESS AS PART OF THE DRUG DEVELOPMENT PROGRAM .... 13 III.
FROM THE BENCH TO THE PILOT PLANT AND BEYOND .... 39 IV. THE
PHYSICOCHEMICAL ATTRIBUTES OF THE BULK DRUG .... 61 V. THE PROCESS BODY
OF KNOWLEDGE .... 65 VI. PROCESSING RESPONSIBILITY IN BULK DRUG PROCESS
DEVELOPMENT .... 73 VTI. OUTSOURCING IN BULK DRUG PROCESS DEVELOPMENT
.... 89 VII VIII CONTENTS VIII. IN CLOSING .... 89 REFERENCES .... 90 3.
BULK DRUGS: PROCESS DESIGN, TECHNOLOGY TRANSFER, AND FIRST MANUFACTURE
93 CARLOS B. ROSAS I. INTRODUCTION .... 93 II. THE PROCESS DESIGN TASK
IN BULK DRUGS .... 96 III. TECHNOLOGY TRANSFER OF THE BULK DRUG PROCESS
AND FIRST MANUFACTURE .... 106 IV. IN CLOSING*THE PROCESSING
TECHNOLOGIES OF BULK DRUGS .... 123 REFERENCES .... 125 4. DESIGN AND
CONSTRUCTION OF FACILITIES 127 STEVEN MONGIARDO AND EUGENE BOBROW I.
INTRODUCTION .... 127 II. BUSINESS REQUIREMENTS .... 129 III. DEVELOPING
THE PRELIMINARY SCOPE .... 132 IV. UTILITIES AND BUILDING SYSTEMS ....
137 V. PRELIMINARY SCOPE DELIVERABLES .... 138 VT. DESIGN DEVELOPMENT
.... 142 VII. UTILITIES .... 147 VIII. SAFETY .... 150 IK. CURRENT GOOD
MANUFACTURING PRACTICES REQUIREMENTS .... 150 X. QUALIFICATION PLAN ....
151 XI. EXPANSION CAPABILITIES .... 152 XII. HAZARD AND OPERABILITY
ANALYSIS .... 152 XIII. EXECUTION STRATEGY AND PLANNING .... 154 XTV.
PROCUREMENT STRATEGY .... 156 XV. CONSTRUCTION MANAGEMENT .... 161 XVI.
START-UP ACCEPTANCE .... 162 XVII. PROJECT TURNOVER AND INSTALLATION
QUALIFICATION .... 163 XVIII. CONCLUSIONS .... 165 REFERENCES .... 166
CONTENTS J X 5. REGULATORY AFFAIRS 167 JOHN CURRAN I. INTRODUCTION ....
167 II. REQUIREMENTS FOR SUBMISSION OF REGULATORY CMC DOCUMENTS .... 169
III. CONTENTS OF REGULATORY SUBMISSIONS*API SECTIONS .... 173 IV.
REGISTRATION SAMPLES .... 191 V. THE REVIEW AND APPROVAL PROCESS ....
192 VI. PREAPPROVAL INSPECTIONS .... 195 VII. POSTAPPROVAL CHANGE
EVALUATIONS .... 196 VIII. THE FUTURE .... 199 K. HELPFUL REFERENCES
.... 200 6. VALIDATION 203 JAMES AGALLOCO AND PHIL DESANTIS I. HISTORY
.... 203 II. DEFINITION OF VALIDATION .... 205 III. REGULATIONS .... 206
IV. APPLICATION OF VALIDATION .... 206 V. LIFE CYCLE MODEL .... 206 VI.
VALIDATION OF NEW PRODUCTS .... 207 VII. VALIDATION OF EXISTING PRODUCTS
.... 208 VIII. IMPLEMENTATION .... 209 DX. BULK PHARMACEUTICAL CHEMICAL
VALIDATION .... 211 X. IN-PROCESS CONTROLS .... 220 XI. CLEANING
VALIDATION .... 222 XII. COMPUTERIZED SYSTEMS .... 225 XIII. PROCEDURES
AND PERSONNEL .... 225 XIV. VALIDATION OF STERILE BULK PRODUCTION ....
225 XV. CONCLUSION .... 231 REFERENCES .... 231 7. QUALITY ASSURANCE AND
CONTROL 235 MICHAEL C. VANDERZWAN I. INTRODUCTION .... 235 II. DEFINING
AND ASSURING THE QUALITY OF THE ACTIVE PHARMACEUTICAL INGREDIENT ....
240 X CONTENTS III. THE REGULATIONS FOR QUALITY .... 245 IV. THE QUALITY
CONTROL AND QUALITY ASSURANCE DEPARTMENT .... 273 APPENDIX A .... 280 8.
PLANT OPERATIONS 285 STANLEY H. NUSIM I. PLANT ORGANIZATION .... 285 II.
BATCH VS. CONTINUOUS .... 286 III. DEDICATED VS. SHARED MANUFACTURING
FACILITIES .... 288 IV. SHIFT OPERATIONS .... 288 V. STERILE OPERATIONS
.... 291 VI. CLEAN ROOM .... 294 VII. COST CONTROL .... 296 VIII. FIXED
OVERHEAD ABSORPTION .... 299 EX. SAFETY .... 300 X. ENVIRONMENTAL ....
303 9. MATERIALS MANAGEMENT 305 VICTOR CATALANO I. INTRODUCTION .... 305
II. PRODUCTION PLANNING .... 306 III. INVENTORY MANAGEMENT .... 307 IV.
PURCHASING/SUPPLY MANAGEMENT .... 308 V. DISTRIBUTION/TRANSPORTATION
.... 315 VI. INFORMATION TECHNOLOGY .... 316 VII. QUALITY MANAGEMENT
.... 317 REFERENCES .... 318 10. PLANT MAINTENANCE 323 RAYMOND J.
OLIVERSON I. INTRODUCTION .... 323 II. STRATEGIC PLAN .... 324 III.
RELIABILITY-BALANCED SCORECARDS .... 325 IV. MAINTENANCE BASICS .... 327
V. CONDITION MONITORING .... 329 VI. OPERATOR-DRIVEN RELIABILITY ....
330 CONTENTS XI VII. RELIABILITY ENGINEERING .... 331 VIII. RISK
MANAGEMENT .... 333 DC. SUMMARY .... 334 INDEX 335
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| isbn | 082470293X |
| language | English |
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| physical | XIV, 337 S. Ill. |
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| series2 | Drugs and the pharmaceutical sciences |
| spelling | Active pharmaceutical ingredients development, manufacturing, and regulation ed. by Stanley H. Nusim Boca Raton, Fla. Taylor & Francis 2005 XIV, 337 S. Ill. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 151 Includes bibliographical references and index Industrie pharmaceutique Médicaments - Droit Médicaments - Développement Techniques pharmaceutiques Recht Drug development Pharmaceutical technology Drugs Law and legislation Pharmaceutical industry Drug Industry organization & administration Chemistry, Pharmaceutical Drug Compounding Legislation, Drug Legislation, Pharmacy Arzneimittel (DE-588)4003115-9 gnd rswk-swf Zulassung (DE-588)4127410-6 gnd rswk-swf Arzneimittelentwicklung (DE-588)4143176-5 gnd rswk-swf Arzneimittelentwicklung (DE-588)4143176-5 s DE-604 Arzneimittel (DE-588)4003115-9 s Zulassung (DE-588)4127410-6 s b DE-604 Nusim, Stanley Sonstige oth Drugs and the pharmaceutical sciences 151 (DE-604)BV000002008 151 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013208501&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Active pharmaceutical ingredients development, manufacturing, and regulation Drugs and the pharmaceutical sciences Industrie pharmaceutique Médicaments - Droit Médicaments - Développement Techniques pharmaceutiques Recht Drug development Pharmaceutical technology Drugs Law and legislation Pharmaceutical industry Drug Industry organization & administration Chemistry, Pharmaceutical Drug Compounding Legislation, Drug Legislation, Pharmacy Arzneimittel (DE-588)4003115-9 gnd Zulassung (DE-588)4127410-6 gnd Arzneimittelentwicklung (DE-588)4143176-5 gnd |
| subject_GND | (DE-588)4003115-9 (DE-588)4127410-6 (DE-588)4143176-5 |
| title | Active pharmaceutical ingredients development, manufacturing, and regulation |
| title_auth | Active pharmaceutical ingredients development, manufacturing, and regulation |
| title_exact_search | Active pharmaceutical ingredients development, manufacturing, and regulation |
| title_full | Active pharmaceutical ingredients development, manufacturing, and regulation ed. by Stanley H. Nusim |
| title_fullStr | Active pharmaceutical ingredients development, manufacturing, and regulation ed. by Stanley H. Nusim |
| title_full_unstemmed | Active pharmaceutical ingredients development, manufacturing, and regulation ed. by Stanley H. Nusim |
| title_short | Active pharmaceutical ingredients |
| title_sort | active pharmaceutical ingredients development manufacturing and regulation |
| title_sub | development, manufacturing, and regulation |
| topic | Industrie pharmaceutique Médicaments - Droit Médicaments - Développement Techniques pharmaceutiques Recht Drug development Pharmaceutical technology Drugs Law and legislation Pharmaceutical industry Drug Industry organization & administration Chemistry, Pharmaceutical Drug Compounding Legislation, Drug Legislation, Pharmacy Arzneimittel (DE-588)4003115-9 gnd Zulassung (DE-588)4127410-6 gnd Arzneimittelentwicklung (DE-588)4143176-5 gnd |
| topic_facet | Industrie pharmaceutique Médicaments - Droit Médicaments - Développement Techniques pharmaceutiques Recht Drug development Pharmaceutical technology Drugs Law and legislation Pharmaceutical industry Drug Industry organization & administration Chemistry, Pharmaceutical Drug Compounding Legislation, Drug Legislation, Pharmacy Arzneimittel Zulassung Arzneimittelentwicklung |
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