Laboratory auditing for quality and regulatory compliance:
Gespeichert in:
| Hauptverfasser: | , , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Boca Raton, Fla.
Taylor&Francis
2005
|
| Schriftenreihe: | Drugs and the pharmaceutical sciences
150 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | VIII, 471 S. Ill. |
| ISBN: | 1574445707 |
Internformat
MARC
| LEADER | 00000nam a2200000zcb4500 | ||
|---|---|---|---|
| 001 | BV020049872 | ||
| 003 | DE-604 | ||
| 005 | 20051116 | ||
| 007 | t | ||
| 008 | 050929s2005 xxua||| |||| 00||| eng d | ||
| 010 | |a 2005043739 | ||
| 020 | |a 1574445707 |c alk. paper |9 1-574-44570-7 | ||
| 035 | |a (OCoLC)58790971 | ||
| 035 | |a (DE-599)BVBBV020049872 | ||
| 040 | |a DE-604 |b ger |e aacr | ||
| 041 | 0 | |a eng | |
| 044 | |a xxu |c US | ||
| 049 | |a DE-12 | ||
| 050 | 0 | |a R860 | |
| 082 | 0 | |a 362.17/7 |2 22 | |
| 100 | 1 | |a Singer, Donald C. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Laboratory auditing for quality and regulatory compliance |c Donald C. Singer , Raluca-Joana Stefan, Jacobus F. van Staden |
| 264 | 1 | |a Boca Raton, Fla. |b Taylor&Francis |c 2005 | |
| 300 | |a VIII, 471 S. |b Ill. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Drugs and the pharmaceutical sciences |v 150 | |
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Laboratoires - Qualité - Contrôle | |
| 650 | 4 | |a Médecine - Laboratoires - Qualité - Contrôle | |
| 650 | 4 | |a Medical laboratories |x Quality control | |
| 650 | 4 | |a Laboratories |x Quality control | |
| 650 | 0 | 7 | |a Forschung |0 (DE-588)4017894-8 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Pharmazie |0 (DE-588)4045705-9 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Medizinisches Labor |0 (DE-588)4193766-1 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Laboratorium |0 (DE-588)4033927-0 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Pharmazeutische Industrie |0 (DE-588)4045696-1 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Qualitätssicherung |0 (DE-588)4126457-5 |2 gnd |9 rswk-swf |
| 689 | 0 | 0 | |a Medizinisches Labor |0 (DE-588)4193766-1 |D s |
| 689 | 0 | 1 | |a Qualitätssicherung |0 (DE-588)4126457-5 |D s |
| 689 | 0 | |5 DE-604 | |
| 689 | 1 | 0 | |a Pharmazeutische Industrie |0 (DE-588)4045696-1 |D s |
| 689 | 1 | 1 | |a Laboratorium |0 (DE-588)4033927-0 |D s |
| 689 | 1 | 2 | |a Qualitätssicherung |0 (DE-588)4126457-5 |D s |
| 689 | 1 | |5 DE-604 | |
| 689 | 2 | 0 | |a Pharmazie |0 (DE-588)4045705-9 |D s |
| 689 | 2 | 1 | |a Forschung |0 (DE-588)4017894-8 |D s |
| 689 | 2 | 2 | |a Laboratorium |0 (DE-588)4033927-0 |D s |
| 689 | 2 | 3 | |a Qualitätssicherung |0 (DE-588)4126457-5 |D s |
| 689 | 2 | |C b |5 DE-604 | |
| 700 | 1 | |a Stefan, Raluca-Ioana |e Verfasser |4 aut | |
| 700 | 1 | |a Van Staden, Jacobus Frederick |e Verfasser |4 aut | |
| 830 | 0 | |a Drugs and the pharmaceutical sciences |v 150 |w (DE-604)BV000002008 |9 150 | |
| 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=013370824&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-013370824 | ||
Datensatz im Suchindex
| _version_ | 1804133626013548544 |
|---|---|
| adam_text | DRUGS AND THE PHARMACEUTICAL SCIENCES
A Series of Textbooks and Monographs
1. Pharmacokinetics, Milo Gibaldi and Donald Perrier
2. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total
Quality Control, Sidney H. Willig, Murray M. Tuckerman,
and William S. Hitchings IV
3. Microencapsulation, edited by J. R. Nixon
4. Drug Metabolism: Chemical and Biochemical Aspects, Bernard Testa
and Peter Jenner
5. New Drugs: Discovery and Development, edited by Alan A. Rubin
6. Sustained and Controlled Release Drug Delivery Systems,
edited by Joseph R. Robinson
7. Modern Pharmaceutics, edited by Gilbert S. Banker
and Christopher T. Rhodes
8. Prescription Drugs in Short Supply: Case Histories, Michael A. Schwartz
9. Activated Charcoal: Antidotal and Other Medical Uses, David O. Cooney
10. Concepts in Drug Metabolism (in two parts), edited by Peter Jenner
and Bernard Testa
11. Pharmaceutical Analysis: Modern Methods (in two parts),
edited by James W. Munson
12. Techniques of Solubilization of Drugs, edited by Samuel H. Yalkowsky
13. Orphan Drugs, edited by Fred E. Karch
14. Novel Drug Delivery Systems: Fundamentals, Developmental Concepts,
Biomedical Assessments, Yie W. Chien
15. Pharmacokinetics: Second Edition, Revised and Expanded, Milo Gibaldi
and Donald Perrier
16. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total
Quality Control, Second Edition, Revised and Expanded, Sidney H. Willig,
Murray M. Tuckerman, and William S. Hitchings IV
17. Formulation of Veterinary Dosage Forms, edited by Jack Blodinger
18. Dermatological Formulations: Percutaneous Absorption, Brian W. Barry
19. The Clinical Research Process in the Pharmaceutical Industry,
edited by Gary M. Matoren
20. Microencapsulation and Related Drug Processes, Patrick B. Deasy
21. Drugs and Nutrients: The Interactive Effects, edited by Daphne A. Roe
and T. Colin Campbell
22. Biotechnology of Industrial Antibiotics, Erick J. Vandamme
23. Pharmaceutical Process Validation, edited by Bernard T. Loftus
and Robert A. Nash
24. Anticancer and Interferon Agents: Synthesis and Properties,
edited by Raphael M. Ottenbrite and George B. Butler
25. Pharmaceutical Statistics: Practical and Clinical Applications,
Sanford Bolton
26. Drug Dynamics for Analytical, Clinical, and Biological Chemists,
Benjamin J. Gudzinowicz, Burrows T. Younkin, Jr.,
and Michael J. Gudzinowicz
27. Modern Analysis of Antibiotics, edited by Adjoran Aszalos
28. Solubility and Related Properties, Kenneth C. James
29. Controlled Drug Delivery: Fundamentals and Applications,
Second Edition, Revised and Expanded, edited by Joseph Ft. Robinson
and Vincent H. Lee
30. New Drug Approval Process: Clinical and Regulatory Management,
edited by Richard A. Guarino
31. Transdermal Controlled Systemic Medications, edited by Vie W. Chien
32. Drug Delivery Devices: Fundamentals and Applications,
edited by Praveen Tyle
33. Pharmacokinetics: Regulatory • Industrial • Academic Perspectives,
edited by Peter G. Welling and Francis L S. Tse
34. Clinical Drug Trials and Tribulations, edited by Allen E. Cato
35. Transdermal Drug Delivery: Developmental Issues and Research
Initiatives, edited by Jonathan Hadgraft and Richard H. Guy
36. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms,
edited by James W. McGinity
37. Pharmaceutical Pelletization Technology, edited by
Isaac Ghebre Sellassie
38. Good Laboratory Practice Regulations, edited by Allen F. Hirsch
39. Nasal Systemic Drug Delivery, Vie W. Chien, Kenneth S. E. Su,
and Shyi Feu Chang
40. Modern Pharmaceutics: Second Edition, Revised and Expanded,
edited by Gilbert S. Banker and Christopher T. Rhodes
41. Specialized Drug Delivery Systems: Manufacturing and Production
Technology, edited by Praveen Tyle
42. Topical Drug Delivery Formulations, edited by David W. Osborne
and Anton H. Amann
43. Drug Stability: Principles and Practices, Jens T, Carstensen
44. Pharmaceutical Statistics: Practical and Clinical Applications,
Second Edition, Revised and Expanded, Sanford Bolton
45. Biodegradable Polymers as Drug Delivery Systems,
edited by Mark Chasin and Robert Langer
46. Preclinical Drug Disposition: A Laboratory Handbook, Francis L S. Tse
and James J. Jaffe
47. HPLC in the Pharmaceutical Industry, edited by Godwin W. Fong
and Stanley K. Lam
48. Pharmaceutical Bioequivalence, edited by Peter G. Welling,
Francis L. S. Tse, and Shrikant V. Dinghe
49. Pharmaceutical Dissolution Testing, Umesh V. Banakar
50. Novel Drug Delivery Systems: Second Edition, Revised and Expanded,
Yie W. Chien
51. Managing the Clinical Drug Development Process, David M. Cocchetto
and Ronald V. Nardi
52. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total
Quality Control, Third Edition, edited by Sidney H. Willig and James R.
Stoker
53. Prodrugs: Topical and Ocular Drug Delivery, edited by Kenneth B. Sloan
54. Pharmaceutical Inhalation Aerosol Technology, edited by
Anthony J. Hickey
55. Radiopharmaceuticals: Chemistry and Pharmacology, edited by
Adrian D. Nunn
56. New Drug Approval Process: Second Edition, Revised and Expanded,
edited by Richard A. Guarino
57. Pharmaceutical Process Validation: Second Edition, Revised
and Expanded, edited by Ira R. Berry and Robert A. Nash
58. Ophthalmic Drug Delivery Systems, edited by Ashim K. Mitra
59. Pharmaceutical Skin Penetration Enhancement, edited by
Kenneth A. Walters and Jonathan Hadgraft
60. Colonic Drug Absorption and Metabolism, edited by Peter R. Bieck
61. Pharmaceutical Particulate Carriers: Therapeutic Applications,
edited by Alain Rolland
62. Drug Permeation Enhancement: Theory and Applications,
edited by Dean S. Hsieh
63. Glycopeptide Antibiotics, edited by Ramakrishnan Nagarajan
64. Achieving Sterility in Medical and Pharmaceutical Products, Nigel A. Halls
65. Multiparticulate Oral Drug Delivery, edited by Isaac Ghebre Sellassie
66. Colloidal Drug Delivery Systems, edited by Jorg Kreuter
67. Pharmacokinetics: Regulatory • Industrial • Academic Perspectives,
Second Edition, edited by Peter G. Welling and Francis L S. Tse
68. Drug Stability: Principles and Practices, Second Edition, Revised
and Expanded, Jens T. Carstensen
69. Good Laboratory Practice Regulations: Second Edition, Revised
and Expanded, edited by Sandy Weinberg
70. Physical Characterization of Pharmaceutical Solids, edited by
Harry G. Brittain
71. Pharmaceutical Powder Compaction Technology, edited by
Goran Alderborn and Christer Nystrom
72. Modern Pharmaceutics: Third Edition, Revised and Expanded,
edited by Gilbert S. Banker and Christopher T. Rhodes
73. Microencapsulation: Methods and Industrial Applications,
edited by Simon Benita
74. Oral Mucosal Drug Delivery, edited by Michael J. Rathbone
75. Clinical Research in Pharmaceutical Development, edited by Barry Bleidt
and Michael Montagne
76. The Drug Development Process: Increasing Efficiency and Cost
Effectiveness, edited by Peter G. Welling, Louis Lasagna,
and Umesh V. Banakar
77. Microparticulate Systems for the Delivery of Proteins and Vaccines,
edited by Smadar Cohen and Howard Bernstein
78. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total
Quality Control, Fourth Edition, Revised and Expanded, Sidney H. Willig
and James R. Stoker
79. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms:
Second Edition, Revised and Expanded, edited by James W. McGinity
80. Pharmaceutical Statistics: Practical and Clinical Applications,
Third Edition, Sanford Bolton
81. Handbook of Pharmaceutical Granulation Technology, edited by
Dilip M. Parikh
82. Biotechnology of Antibiotics: Second Edition, Revised and Expanded,
edited by William R. Strohl
83. Mechanisms of Transdermal Drug Delivery, edited by Russell O. Potts
and Richard H. Guy
84. Pharmaceutical Enzymes, edited by Albert Lauwers and Simon Scharpe
85. Development of Biopharmaceutical Parenteral Dosage Forms,
edited by John A. Bontempo
86. Pharmaceutical Project Management, edited by Tony Kennedy
87. Drug Products for Clinical Trials: An International Guide to Formulation •
Production • Quality Control, edited by Donald C. Monkhouse
and Christopher T. Rhodes
88. Development and Formulation of Veterinary Dosage Forms: Second
Edition, Revised and Expanded, edited by Gregory £ Hardee
and J. Desmond Baggot
89. Receptor Based Drug Design, edited by Paul Left
90. Automation and Validation of Information in Pharmaceutical Processing,
edited by Joseph F. deSpautz
91. Dermal Absorption and Toxicity Assessment, edited by Michael S. Roberts
and Kenneth A. Walters
92. Pharmaceutical Experimental Design, Gareth A. Lewis, Didier Mathieu,
and Roger Phan Tan Luu
93. Preparing for FDA Pre Approval Inspections, edited by Martin D. Hynes III
94. Pharmaceutical Excipients: Characterization by IR, Raman, and NMR
Spectroscopy, David E. Bugay and W. Paul Findlay
95. Polymorphism in Pharmaceutical Solids, edited by Harry G. Brittain
96. Freeze Drying/Lyophilization of Pharmaceutical and Biological Products,
edited by Louis Rey and Joan C. May
97. Percutaneous Absorption: Drugs Cosmetics Mechanisms Methodology,
Third Edition, Revised and Expanded, edited by Robert L. Bronaugh
and Howard I. Maibach
98. Bioadhesive Drug Delivery Systems: Fundamentals, Novel Approaches,
and Development, edited by Edith Mathiowitz, Donald E. Chickering III,
and Claus Michael Lehr
99. Protein Formulation and Delivery, edited by Eugene J. McNally
100. New Drug Approval Process: Third Edition, The Global Challenge,
edited by Richard A. Guarino
101. Peptide and Protein Drug Analysis, edited by Ronald E. Reid
102. Transport Processes in Pharmaceutical Systems, edited by
Gordon L. Amidon, Ping I. Lee, and Elizabeth M. Topp
103. Excipient Toxicity and Safety, edited by Myra L. Weiner
and Lois A. Kotkoskie
104. The Clinical Audit in Pharmaceutical Development, edited by
Michael R. Hamrell
105. Pharmaceutical Emulsions and Suspensions, edited by
Francoise Nielloud and Gilberte Marti Mestres
106. Oral Drug Absorption: Prediction and Assessment, edited by
Jennifer B. Dressman and Hans Lennernas
107. Drug Stability: Principles and Practices, Third Edition, Revised
and Expanded, edited by Jens T. Carstensen and C. T. Rhodes
108. Containment in the Pharmaceutical Industry, edited by James P. Wood
109. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total
Quality Control from Manufacturer to Consumer, Fifth Edition, Revised
and Expanded, Sidney H. Willig
110. Advanced Pharmaceutical Solids, Jens T. Carstensen
111. Endotoxins: Pyrogens, LAL Testing, and Depyrogenation, Second Edition,
Revised and Expanded, Kevin L. Williams
112. Pharmaceutical Process Engineering, Anthony J. Hickey
and David Ganderton
113. Pharmacogenomics, edited by Werner Kalow, Urs A. Meyer,
and Rachel F. Tyndale
114. Handbook of Drug Screening, edited by Ramakrishna Seethala
and Prabhavathi B. Fernandes
115. Drug Targeting Technology: Physical • Chemical • Biological Methods,
edited by Hans Schreier
116. Drug Drug Interactions, edited by A. David Rodrigues
117. Handbook of Pharmaceutical Analysis, edited by Lena Ohannesian
and Anthony J. Streeter
118. Pharmaceutical Process Scale Up, edited by Michael Levin
119. Dermatological and Transdermal Formulations, edited by
Kenneth A. Walters
120. Clinical Drug Trials and Tribulations: Second Edition, Revised and
Expanded, edited by Allen Cato, Lynda Sutton, and Allen Cato III
121. Modern Pharmaceutics: Fourth Edition, Revised and Expanded,
edited by Gilbert S. Banker and Christopher T. Rhodes
122. Surfactants and Polymers in Drug Delivery, Martin Malmsten
123. Transdermal Drug Delivery: Second Edition, Revised and Expanded,
edited by Richard H. Guy and Jonathan Hadgraft
124. Good Laboratory Practice Regulations: Second Edition,
Revised and Expanded, edited by Sandy Weinberg
125. Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package
Integrity Testing: Third Edition, Revised and Expanded, Michael J. Akers,
Daniel S. Larrimore, and Dana Morton Guazzo
126. Modified Release Drug Delivery Technology, edited by
Michael J. Rathbone, Jonathan Hadgraft, and Michael S. Roberts
127. Simulation for Designing Clinical Trials: A Pharmacokinetic
Pharmacodynamic Modeling Perspective, edited by Hui C. Kimko
and Stephen B. Duffull
128. Affinity Capillary Electrophoresis in Pharmaceutics and Biopharmaceutics,
edited by Reinhard H. H. Neubert and Hans Hermann Ruttinger
129. Pharmaceutical Process Validation: An International Third Edition,
Revised and Expanded, edited by Robert A. Nash and Alfred H. Wachter
130. Ophthalmic Drug Delivery Systems: Second Edition, Revised
and Expanded, edited by Ashim K. Mitra
131. Pharmaceutical Gene Delivery Systems, edited by Alain Rolland
and Sean M. Sullivan
132. Biomarkers in Clinical Drug Development, edited by John C. Bloom
and Robert A. Dean
133. Pharmaceutical Extrusion Technology, edited by Isaac Ghebre Sellassie
and Charles Martin
134. Pharmaceutical Inhalation Aerosol Technology: Second Edition,
Revised and Expanded, edited by Anthony J. Hickey
135. Pharmaceutical Statistics: Practical and Clinical Applications,
Fourth Edition, Sanford Bolton and Charles Bon
136. Compliance Handbook for Pharmaceuticals, Medical Devices, I
and Biologies, edited by Carmen Medina j
137. Freeze Drying/Lyophilization of Pharmaceutical and Biological Products:
Second Edition, Revised and Expanded, edited by Louis Rey
and Joan C, May
138. Supercritical Fluid Technology for Drug Product Development,
edited by Peter York, Uday B. Kompella, and Boris Y Shekunov
139. New Drug Approval Process: Fourth Edition, Accelerating Global
Registrations, edited by Richard A. Guarino
140. Microbial Contamination Control in Parenteral Manufacturing,
edited by Kevin L Williams
141. New Drug Development: Regulatory Paradigms for Clinical Pharmacology
and Biopharmaceutics, edited by Chandrahas G. Sahajwalla
142. Microbial Contamination Control in the Pharmaceutical Industry,
edited by Luis Jimenez
143. Generic Drug Product Development: Solid Oral Dosage Forms,
edited by Leon Shargel and Izzy Kanfer
144. Introduction to the Pharmaceutical Regulatory Process,
edited by Ira R. Berry
145. Drug Delivery to the Oral Cavity: Molecules to Market, edited by
Tapash K. Ghosh and William R. Pfister
146. Good Design Practices for GMP Pharmaceutical Facilities,
edited by Andrew Signore and Terry Jacobs
147. Drug Products for Clinical Trials, Second Edition, edited by Donald
Monkhouse, Charles Carney, and Jim Clark
148. Polymeric Drug Delivery Systems, edited by Glen S. Kwon
149. Injectable Dispersed Systems: Formulation, Processing, and Performance,
edited by Diane J. Burgess
150. Laboratory Auditing for Quality and Regulatory Compliance,
Donald C. Singer, Raluca loana Stefan, and Jacobus F. van Staden
CONTENTS
Preface .... Hi
Introduction .... vii
I. Quality and Auditing /
Quality Control and Quality Assurance
in a Laboratory .... 1
The Regulated Industries .... 3
Goals of a Laboratory Quality Audit .... 5
Audit Tools: Observation, Working Knowledge,
and Audit Documents .... 7
II. Nontechnical Parameters for Evaluation 9
Quality Programs, Documentation, and Organizational
Structure .... 9
Personnel .... 14
Facility and Environment .... 15
III. Technical Parameters for Evaluation 19
Sample Control .... 19
Instrumentation .... 20
Automation of Analytical Process .... 22
Acquisition and Processing of Data .... 23
Uncertainty of Measurements .... 24
Reliability of Measurements .... 26
Standards and Standardization .... 26
Supplies Organization .... 27
Proficiency Testing .... 28
v
Vi Contents
IV. Other Areas to Consider 29
Customer Satisfaction .... 29
Laboratory Health and Safety .... 29
V. Communications and Follow Up 31
Closing Conference, Final Report, and
Follow Up .... 31
Frequency of Audit .... 33
Epilog 35
Appendices
A. Sample Laboratory Quality Audit Document .... 37
B. National Voluntary Laboratory Accreditation Program,
NIST Handbook 150 .... 51
C. Guide to Quality in Analytical Chemistry
(Eurachem/CITAC) .... 117
D. Quality Assurance for Research and Development and
Nonroutine Analysis (EURACHEM/CITAC) .... 175
E. Accreditation for Microbiological Laboratories
(Eurachem/EA) .... 229
F. EPA Manual for Certification of Laboratories Analyzing
Drinking Water .... 253
G. Federal Register (FDA): Good Laboratory
Practice Regulations for Nonclinical
Laboratory Studies .... 443
Bibliography 465
Index 469
|
| any_adam_object | 1 |
| author | Singer, Donald C. Stefan, Raluca-Ioana Van Staden, Jacobus Frederick |
| author_facet | Singer, Donald C. Stefan, Raluca-Ioana Van Staden, Jacobus Frederick |
| author_role | aut aut aut |
| author_sort | Singer, Donald C. |
| author_variant | d c s dc dcs r i s ris s j f v sjf sjfv |
| building | Verbundindex |
| bvnumber | BV020049872 |
| callnumber-first | R - Medicine |
| callnumber-label | R860 |
| callnumber-raw | R860 |
| callnumber-search | R860 |
| callnumber-sort | R 3860 |
| callnumber-subject | R - General Medicine |
| ctrlnum | (OCoLC)58790971 (DE-599)BVBBV020049872 |
| dewey-full | 362.17/7 |
| dewey-hundreds | 300 - Social sciences |
| dewey-ones | 362 - Social problems and services to groups |
| dewey-raw | 362.17/7 |
| dewey-search | 362.17/7 |
| dewey-sort | 3362.17 17 |
| dewey-tens | 360 - Social problems and services; associations |
| discipline | Soziologie |
| format | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>02635nam a2200637zcb4500</leader><controlfield tag="001">BV020049872</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20051116 </controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">050929s2005 xxua||| |||| 00||| eng d</controlfield><datafield tag="010" ind1=" " ind2=" "><subfield code="a">2005043739</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">1574445707</subfield><subfield code="c">alk. paper</subfield><subfield code="9">1-574-44570-7</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)58790971</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV020049872</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">aacr</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="044" ind1=" " ind2=" "><subfield code="a">xxu</subfield><subfield code="c">US</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-12</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">R860</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">362.17/7</subfield><subfield code="2">22</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Singer, Donald C.</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Laboratory auditing for quality and regulatory compliance</subfield><subfield code="c">Donald C. Singer , Raluca-Joana Stefan, Jacobus F. van Staden</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Boca Raton, Fla.</subfield><subfield code="b">Taylor&Francis</subfield><subfield code="c">2005</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">VIII, 471 S.</subfield><subfield code="b">Ill.</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">150</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Includes bibliographical references and index</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Laboratoires - Qualité - Contrôle</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Médecine - Laboratoires - Qualité - Contrôle</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Medical laboratories</subfield><subfield code="x">Quality control</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Laboratories</subfield><subfield code="x">Quality control</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Forschung</subfield><subfield code="0">(DE-588)4017894-8</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Pharmazie</subfield><subfield code="0">(DE-588)4045705-9</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Medizinisches Labor</subfield><subfield code="0">(DE-588)4193766-1</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Laboratorium</subfield><subfield code="0">(DE-588)4033927-0</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="650" ind1="0" ind2="7"><subfield code="a">Qualitätssicherung</subfield><subfield code="0">(DE-588)4126457-5</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">Medizinisches Labor</subfield><subfield code="0">(DE-588)4193766-1</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="1"><subfield code="a">Qualitätssicherung</subfield><subfield code="0">(DE-588)4126457-5</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">Pharmazeutische Industrie</subfield><subfield code="0">(DE-588)4045696-1</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="1"><subfield code="a">Laboratorium</subfield><subfield code="0">(DE-588)4033927-0</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="2"><subfield code="a">Qualitätssicherung</subfield><subfield code="0">(DE-588)4126457-5</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="689" ind1="2" ind2="0"><subfield code="a">Pharmazie</subfield><subfield code="0">(DE-588)4045705-9</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="2" ind2="1"><subfield code="a">Forschung</subfield><subfield code="0">(DE-588)4017894-8</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="2" ind2="2"><subfield code="a">Laboratorium</subfield><subfield code="0">(DE-588)4033927-0</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="2" ind2="3"><subfield code="a">Qualitätssicherung</subfield><subfield code="0">(DE-588)4126457-5</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="2" ind2=" "><subfield code="C">b</subfield><subfield code="5">DE-604</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Stefan, Raluca-Ioana</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Van Staden, Jacobus Frederick</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">150</subfield><subfield code="w">(DE-604)BV000002008</subfield><subfield code="9">150</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=013370824&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:BVB01-013370824</subfield></datafield></record></collection> |
| id | DE-604.BV020049872 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T20:11:42Z |
| institution | BVB |
| isbn | 1574445707 |
| language | English |
| lccn | 2005043739 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-013370824 |
| oclc_num | 58790971 |
| open_access_boolean | |
| owner | DE-12 |
| owner_facet | DE-12 |
| physical | VIII, 471 S. Ill. |
| publishDate | 2005 |
| publishDateSearch | 2005 |
| publishDateSort | 2005 |
| publisher | Taylor&Francis |
| record_format | marc |
| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | Singer, Donald C. Verfasser aut Laboratory auditing for quality and regulatory compliance Donald C. Singer , Raluca-Joana Stefan, Jacobus F. van Staden Boca Raton, Fla. Taylor&Francis 2005 VIII, 471 S. Ill. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 150 Includes bibliographical references and index Laboratoires - Qualité - Contrôle Médecine - Laboratoires - Qualité - Contrôle Medical laboratories Quality control Laboratories Quality control Forschung (DE-588)4017894-8 gnd rswk-swf Pharmazie (DE-588)4045705-9 gnd rswk-swf Medizinisches Labor (DE-588)4193766-1 gnd rswk-swf Laboratorium (DE-588)4033927-0 gnd rswk-swf Pharmazeutische Industrie (DE-588)4045696-1 gnd rswk-swf Qualitätssicherung (DE-588)4126457-5 gnd rswk-swf Medizinisches Labor (DE-588)4193766-1 s Qualitätssicherung (DE-588)4126457-5 s DE-604 Pharmazeutische Industrie (DE-588)4045696-1 s Laboratorium (DE-588)4033927-0 s Pharmazie (DE-588)4045705-9 s Forschung (DE-588)4017894-8 s b DE-604 Stefan, Raluca-Ioana Verfasser aut Van Staden, Jacobus Frederick Verfasser aut Drugs and the pharmaceutical sciences 150 (DE-604)BV000002008 150 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013370824&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Singer, Donald C. Stefan, Raluca-Ioana Van Staden, Jacobus Frederick Laboratory auditing for quality and regulatory compliance Drugs and the pharmaceutical sciences Laboratoires - Qualité - Contrôle Médecine - Laboratoires - Qualité - Contrôle Medical laboratories Quality control Laboratories Quality control Forschung (DE-588)4017894-8 gnd Pharmazie (DE-588)4045705-9 gnd Medizinisches Labor (DE-588)4193766-1 gnd Laboratorium (DE-588)4033927-0 gnd Pharmazeutische Industrie (DE-588)4045696-1 gnd Qualitätssicherung (DE-588)4126457-5 gnd |
| subject_GND | (DE-588)4017894-8 (DE-588)4045705-9 (DE-588)4193766-1 (DE-588)4033927-0 (DE-588)4045696-1 (DE-588)4126457-5 |
| title | Laboratory auditing for quality and regulatory compliance |
| title_auth | Laboratory auditing for quality and regulatory compliance |
| title_exact_search | Laboratory auditing for quality and regulatory compliance |
| title_full | Laboratory auditing for quality and regulatory compliance Donald C. Singer , Raluca-Joana Stefan, Jacobus F. van Staden |
| title_fullStr | Laboratory auditing for quality and regulatory compliance Donald C. Singer , Raluca-Joana Stefan, Jacobus F. van Staden |
| title_full_unstemmed | Laboratory auditing for quality and regulatory compliance Donald C. Singer , Raluca-Joana Stefan, Jacobus F. van Staden |
| title_short | Laboratory auditing for quality and regulatory compliance |
| title_sort | laboratory auditing for quality and regulatory compliance |
| topic | Laboratoires - Qualité - Contrôle Médecine - Laboratoires - Qualité - Contrôle Medical laboratories Quality control Laboratories Quality control Forschung (DE-588)4017894-8 gnd Pharmazie (DE-588)4045705-9 gnd Medizinisches Labor (DE-588)4193766-1 gnd Laboratorium (DE-588)4033927-0 gnd Pharmazeutische Industrie (DE-588)4045696-1 gnd Qualitätssicherung (DE-588)4126457-5 gnd |
| topic_facet | Laboratoires - Qualité - Contrôle Médecine - Laboratoires - Qualité - Contrôle Medical laboratories Quality control Laboratories Quality control Forschung Pharmazie Medizinisches Labor Laboratorium Pharmazeutische Industrie Qualitätssicherung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013370824&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000002008 |
| work_keys_str_mv | AT singerdonaldc laboratoryauditingforqualityandregulatorycompliance AT stefanralucaioana laboratoryauditingforqualityandregulatorycompliance AT vanstadenjacobusfrederick laboratoryauditingforqualityandregulatorycompliance |