Good manufacturing practices for pharmaceuticals: a plan for total quality control from manufacturer to consumer
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Dekker
2001
|
| Ausgabe: | 5. ed., rev. and expanded |
| Schriftenreihe: | Drugs and the pharmaceutical sciences
109 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XII, 732 S. graph. Darst. |
| ISBN: | 0824704258 |
Internformat
MARC
| LEADER | 00000nam a2200000 cb4500 | ||
|---|---|---|---|
| 001 | BV017225640 | ||
| 003 | DE-604 | ||
| 005 | 20050613 | ||
| 007 | t | ||
| 008 | 030618s2001 d||| |||| 00||| eng d | ||
| 020 | |a 0824704258 |9 0-8247-0425-8 | ||
| 035 | |a (OCoLC)611007518 | ||
| 035 | |a (DE-599)BVBBV017225640 | ||
| 040 | |a DE-604 |b ger |e rakwb | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-12 | ||
| 100 | 1 | |a Willig, Sidney H. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Good manufacturing practices for pharmaceuticals |b a plan for total quality control from manufacturer to consumer |c Sidney H. Willig ; James R. Stoker |
| 250 | |a 5. ed., rev. and expanded | ||
| 264 | 1 | |a New York [u.a.] |b Dekker |c 2001 | |
| 300 | |a XII, 732 S. |b graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Drugs and the pharmaceutical sciences |v 109 | |
| 650 | 0 | 7 | |a Pharmazeutische Technologie |0 (DE-588)4045699-7 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a GMP-Regeln |0 (DE-588)4113765-6 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Pharmazeutische Industrie |0 (DE-588)4045696-1 |2 gnd |9 rswk-swf |
| 651 | 7 | |a USA |0 (DE-588)4078704-7 |2 gnd |9 rswk-swf | |
| 689 | 0 | 0 | |a USA |0 (DE-588)4078704-7 |D g |
| 689 | 0 | 1 | |a Pharmazeutische Industrie |0 (DE-588)4045696-1 |D s |
| 689 | 0 | 2 | |a GMP-Regeln |0 (DE-588)4113765-6 |D s |
| 689 | 0 | |5 DE-604 | |
| 689 | 1 | 0 | |a USA |0 (DE-588)4078704-7 |D g |
| 689 | 1 | 1 | |a Pharmazeutische Technologie |0 (DE-588)4045699-7 |D s |
| 689 | 1 | 2 | |a GMP-Regeln |0 (DE-588)4113765-6 |D s |
| 689 | 1 | |5 DE-604 | |
| 700 | 1 | |a Stoker, James R |e Verfasser |4 aut | |
| 830 | 0 | |a Drugs and the pharmaceutical sciences |v 109 |w (DE-604)BV000002008 |9 109 | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010382056&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-010382056 | ||
Datensatz im Suchindex
| _version_ | 1804130075895922688 |
|---|---|
| adam_text | Contents
Preface »
Introduction IX
1. Status and Applicability of U.S. Regulations: Current Good
Manufacturing Practices in Manufacturing, Processing,
Packaging, and Holdings of Drugs
2. Finished Pharmaceuticals: General Provisions (Subpart A) 16
3. Organization and Personnel (Subpart B) 30
4. Buildings and Facilities (Subpart C) 43
5. Equipment (Subpart D) 65
6. Control of Components and Drug Product Containers and
Closures (Subpart E) 81
7. Production and Process Controls (Subpart F) 99
8. Packaging and Labeling Controls (Subpart G) 139
9. Holding and Distribution (Subpart H) 173
vii
viii Contents
10. Laboratory Controls (Subpart I) 177
11. Records and Reports (Subpart J) 209
12. Returned and Salvaged Drug Products (Subpart K) 236
13. Repacking and Relabeling 242
14. Bulk Pharmaceutical Chemicals 256
15. The Pharmacist and Total Quality Control 273
16. Recalls and CGMPs: Enforcement Alternatives in the United States 301
17. Controlled Substances Safeguards (21 CFR 1300, et seq.) 317
18. The Inspection Procedure for Compliance in the United States:
The Regulatee Is Inspected; The Rationale for Inspection
(21 USC 373, 374) 321
19. FDA Pre Approval Inspections/Investigations; The Road from
SUPAC to the Food and Drug Modernization Act 367
20. Who Is the Manufacturer? Some Additional Considerations for
the Multinational 379
21. Other GMPs 389
22. Other Approaches to Quality 408
23. Import and Export of Pharmaceuticals and Other Products
Subject to CGMPs 425
24. Enhancement of Global Product Distribution 438
Appendix A Food and Drug Modernization Act of 1997—in
Pertinent Part 453
Appendix B Components/Repackagers 548
Appendix C Hearing Procedures When FDA Proposes the Imposition
of Civil Money Penalties 613
Appendix D Section 601.12 Changes Currently Considered
Important by CBER 662
Appendix E USP24 NF19 Information; Monographs; Tests; Assays 691
Index 719
|
| any_adam_object | 1 |
| author | Willig, Sidney H. Stoker, James R |
| author_facet | Willig, Sidney H. Stoker, James R |
| author_role | aut aut |
| author_sort | Willig, Sidney H. |
| author_variant | s h w sh shw j r s jr jrs |
| building | Verbundindex |
| bvnumber | BV017225640 |
| ctrlnum | (OCoLC)611007518 (DE-599)BVBBV017225640 |
| edition | 5. ed., rev. and expanded |
| format | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01910nam a2200457 cb4500</leader><controlfield tag="001">BV017225640</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20050613 </controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">030618s2001 d||| |||| 00||| eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">0824704258</subfield><subfield code="9">0-8247-0425-8</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)611007518</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV017225640</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-12</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Willig, Sidney H.</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Good manufacturing practices for pharmaceuticals</subfield><subfield code="b">a plan for total quality control from manufacturer to consumer</subfield><subfield code="c">Sidney H. Willig ; James R. Stoker</subfield></datafield><datafield tag="250" ind1=" " ind2=" "><subfield code="a">5. ed., rev. and expanded</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">New York [u.a.]</subfield><subfield code="b">Dekker</subfield><subfield code="c">2001</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">XII, 732 S.</subfield><subfield code="b">graph. Darst.</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="1" ind2=" "><subfield code="a">Drugs and the pharmaceutical sciences</subfield><subfield code="v">109</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Pharmazeutische Technologie</subfield><subfield code="0">(DE-588)4045699-7</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">GMP-Regeln</subfield><subfield code="0">(DE-588)4113765-6</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Pharmazeutische Industrie</subfield><subfield code="0">(DE-588)4045696-1</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="651" ind1=" " ind2="7"><subfield code="a">USA</subfield><subfield code="0">(DE-588)4078704-7</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">USA</subfield><subfield code="0">(DE-588)4078704-7</subfield><subfield code="D">g</subfield></datafield><datafield tag="689" ind1="0" ind2="1"><subfield code="a">Pharmazeutische Industrie</subfield><subfield code="0">(DE-588)4045696-1</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="2"><subfield code="a">GMP-Regeln</subfield><subfield code="0">(DE-588)4113765-6</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="689" ind1="1" ind2="0"><subfield code="a">USA</subfield><subfield code="0">(DE-588)4078704-7</subfield><subfield code="D">g</subfield></datafield><datafield tag="689" ind1="1" ind2="1"><subfield code="a">Pharmazeutische Technologie</subfield><subfield code="0">(DE-588)4045699-7</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="2"><subfield code="a">GMP-Regeln</subfield><subfield code="0">(DE-588)4113765-6</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Stoker, James R</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="830" ind1=" " ind2="0"><subfield code="a">Drugs and the pharmaceutical sciences</subfield><subfield code="v">109</subfield><subfield code="w">(DE-604)BV000002008</subfield><subfield code="9">109</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">HBZ Datenaustausch</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010382056&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-010382056</subfield></datafield></record></collection> |
| geographic | USA (DE-588)4078704-7 gnd |
| geographic_facet | USA |
| id | DE-604.BV017225640 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T19:15:16Z |
| institution | BVB |
| isbn | 0824704258 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-010382056 |
| oclc_num | 611007518 |
| open_access_boolean | |
| owner | DE-12 |
| owner_facet | DE-12 |
| physical | XII, 732 S. graph. Darst. |
| publishDate | 2001 |
| publishDateSearch | 2001 |
| publishDateSort | 2001 |
| publisher | Dekker |
| record_format | marc |
| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | Willig, Sidney H. Verfasser aut Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer Sidney H. Willig ; James R. Stoker 5. ed., rev. and expanded New York [u.a.] Dekker 2001 XII, 732 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 109 Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf GMP-Regeln (DE-588)4113765-6 gnd rswk-swf Pharmazeutische Industrie (DE-588)4045696-1 gnd rswk-swf USA (DE-588)4078704-7 gnd rswk-swf USA (DE-588)4078704-7 g Pharmazeutische Industrie (DE-588)4045696-1 s GMP-Regeln (DE-588)4113765-6 s DE-604 Pharmazeutische Technologie (DE-588)4045699-7 s Stoker, James R Verfasser aut Drugs and the pharmaceutical sciences 109 (DE-604)BV000002008 109 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010382056&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Willig, Sidney H. Stoker, James R Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer Drugs and the pharmaceutical sciences Pharmazeutische Technologie (DE-588)4045699-7 gnd GMP-Regeln (DE-588)4113765-6 gnd Pharmazeutische Industrie (DE-588)4045696-1 gnd |
| subject_GND | (DE-588)4045699-7 (DE-588)4113765-6 (DE-588)4045696-1 (DE-588)4078704-7 |
| title | Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer |
| title_auth | Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer |
| title_exact_search | Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer |
| title_full | Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer Sidney H. Willig ; James R. Stoker |
| title_fullStr | Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer Sidney H. Willig ; James R. Stoker |
| title_full_unstemmed | Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer Sidney H. Willig ; James R. Stoker |
| title_short | Good manufacturing practices for pharmaceuticals |
| title_sort | good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer |
| title_sub | a plan for total quality control from manufacturer to consumer |
| topic | Pharmazeutische Technologie (DE-588)4045699-7 gnd GMP-Regeln (DE-588)4113765-6 gnd Pharmazeutische Industrie (DE-588)4045696-1 gnd |
| topic_facet | Pharmazeutische Technologie GMP-Regeln Pharmazeutische Industrie USA |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010382056&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000002008 |
| work_keys_str_mv | AT willigsidneyh goodmanufacturingpracticesforpharmaceuticalsaplanfortotalqualitycontrolfrommanufacturertoconsumer AT stokerjamesr goodmanufacturingpracticesforpharmaceuticalsaplanfortotalqualitycontrolfrommanufacturertoconsumer |