Pharmaceutical Analysis for Small Molecules

 
 
Standards Information Network (Verlag)
  • erschienen am 12. Juli 2017
  • |
  • 256 Seiten
 
E-Book | PDF mit Adobe-DRM | Systemvoraussetzungen
978-1-119-42503-8 (ISBN)
 
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals
Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates--especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors--into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry.
This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book.
Topics covered include:
* Drug Approval Process and Regulatory Requirements (private standards)
* Pharmacopeias and Compendial Approval Process (public standards)
* Common methods in pharmaceutical analysis (typically compendial)
* Common Calculations for assays and impurities and other specific tests
* Analytical Method Validation, Verification, Transfer
* Specifications including how to handle out of specification (OOS) and out of trend (OOT)
* Impurities including organic, inorganic, residual solvents and elemental impurities
* Good Documentation Practices for regulatory environment
* Management of Analytical Laboratories
* Analytical Instrument Qualifications including IQ, OQ, PQ and VQ
Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted.
Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
1. Auflage
  • Englisch
  • New York
  • |
  • USA
John Wiley & Sons Inc
  • Für Beruf und Forschung
  • 3,15 MB
978-1-119-42503-8 (9781119425038)
weitere Ausgaben werden ermittelt
Behnam Davani, PhD, has more than 25 years' experience in analytical chemistry, compendial and regulatory science, QC/QA and cGMPs. He is Principal Scientific Liaison in the General Chapters Group, Science Division of the United States Pharmacopeia (USP). In this role, he coordinates the identification and scientific development of compendial courses for stakeholders worldwide. He is also an active faculty for USP Global Education and Training department and teaches several compendial courses including method validation/verification/transfer, impurities in drug substances and products, compendial HPLC, residual solvents, stability studies for drug substances and products, and spectroscopy. He has taught these courses in the US as well as to international regulatory bodies and global pharmaceutical industries including in Europe, Canada, China, India, Russia, Korea, Latin America, Middle East, and North Africa.
1 - Cover [Seite 1]
2 - Title Page [Seite 5]
3 - Copyright [Seite 6]
4 - Dedication [Seite 7]
5 - Contents [Seite 9]
6 - About the Editor [Seite 18]
7 - List of Contributors [Seite 20]
8 - Preface [Seite 23]
9 - Acknowledgment [Seite 27]
10 - Chapter 1 Drug Approval Process and Regulatory Requirements [Seite 29]
10.1 - 1.1 Introduction [Seite 29]
10.2 - 1.2 The Regulatory Process for New Drug Entity [Seite 30]
10.2.1 - 1.2.1 Preclinical Studies [Seite 30]
10.2.2 - 1.2.2 Investigational New Drug Application (INDA) [Seite 30]
10.2.2.1 - 1.2.2.1 Phase 1 Clinical [Seite 30]
10.2.2.2 - 1.2.2.2 Phase 2 Clinical [Seite 31]
10.2.2.3 - 1.2.2.3 Phase 3 Clinical [Seite 31]
10.2.3 - 1.2.3 New Drug Application (NDA) [Seite 31]
10.2.3.1 - 1.2.3.1 NDA Review by FDA [Seite 31]
10.2.3.2 - 1.2.3.2 NDA Review Process [Seite 32]
10.3 - 1.3 Good Laboratory Practice for Nonclinical Laboratory Studies [Seite 33]
10.4 - 1.4 Validation of Analytical Procedures: Methodology [Seite 34]
10.5 - 1.5 FDA Role in the Discovery and Development of New Drug Entities [Seite 35]
10.5.1 - 1.5.1 INDA Analytical Requirements [Seite 35]
10.5.2 - 1.5.2 NDA Analytical Requirements [Seite 36]
10.5.3 - 1.5.3 Biotechnology?Derived Products - Small Molecules [Seite 36]
10.6 - 1.6 FDA Inspectors' Role in Analytics Relative to Products in the Marketplace [Seite 37]
10.6.1 - 1.6.1 FDA Compliance Program Guidance Manual (Implemented on 09/11/2015 with a Completion Date of 09/11/2016 - Program 7356.002) [Seite 37]
10.6.2 - 1.6.2 Guide for Inspection of Microbiological Pharmaceutical Quality Control Laboratories [Seite 38]
10.6.3 - 1.6.3 Biotechnology Inspection Guide [Seite 39]
10.7 - 1.7 Conclusions [Seite 40]
10.8 - References [Seite 40]
11 - Chapter 2 Pharmacopeias and Compendial Approval Process [Seite 42]
11.1 - 2.1 Introduction [Seite 42]
11.2 - 2.2 USP History [Seite 42]
11.3 - 2.3 Evolution of the Mission of the USP [Seite 43]
11.4 - 2.4 The USP Organization [Seite 44]
11.4.1 - 2.4.1 The USP Convention [Seite 44]
11.4.2 - 2.4.2 The Board of Trustees [Seite 44]
11.4.3 - 2.4.3 The Council of Experts [Seite 44]
11.4.4 - 2.4.4 Expert Panels to the Council of Experts [Seite 44]
11.4.5 - 2.4.5 Stakeholder Forums and Project Teams [Seite 45]
11.4.6 - 2.4.6 USP Staff [Seite 45]
11.5 - 2.5 The USP-NF Revision Process [Seite 45]
11.6 - 2.6 Publications of USP [Seite 46]
11.6.1 - 2.6.1 USP?NF [Seite 46]
11.6.2 - 2.6.2 Pharmacopeial Forum [Seite 46]
11.6.3 - 2.6.3 Supplements [Seite 46]
11.6.4 - 2.6.4 USP Spanish Edition [Seite 46]
11.6.5 - 2.6.5 USP Reference Standards [Seite 46]
11.6.6 - 2.6.6 Chromatographic Columns [Seite 46]
11.6.7 - 2.6.7 USP Dictionary [Seite 46]
11.6.8 - 2.6.8 USP Dietary Supplements Compendium [Seite 47]
11.6.9 - 2.6.9 Food Chemical Codex [Seite 47]
11.6.10 - 2.6.10 USP Medicines Compendium [Seite 47]
11.7 - 2.7 Relationship between USP and FDA [Seite 47]
11.8 - 2.8 USP and the Pharmacopoeias of Europe and Japan [Seite 48]
11.8.1 - 2.8.1 The European Pharmacopoeia [Seite 48]
11.8.2 - 2.8.2 The Pharmacopeia of Japan [Seite 49]
11.9 - 2.9 Harmonization of Pharmacopeial Monographs and General Chapters [Seite 49]
11.9.1 - 2.9.1 PDG Working Procedures [Seite 50]
11.9.2 - 2.9.2 Status of the Pharmacopeial Harmonization Initiative [Seite 53]
11.9.3 - 2.9.3 Roles and Responsibilities of Major Stakeholders in Pharmacopeial Harmonization [Seite 56]
11.9.4 - 2.9.4 The Roles and Responsibilities of Industry in Pharmacopeial Harmonization [Seite 57]
11.9.5 - 2.9.5 The Roles and Responsibilities of the Regulatory Agencies in Pharmacopeial Harmonization [Seite 58]
11.9.6 - 2.9.6 The Roles and Responsibilities of the International Conference on Harmonization (ICH) in Pharmacopeial Harmonization [Seite 58]
11.9.7 - 2.9.7 Advantages of Pharmacopeial Harmonization [Seite 59]
11.9.8 - 2.9.8 Disadvantages of Pharmacopeial Harmonization [Seite 59]
11.10 - 2.10 Comparisons between the PDG Process and the ICH Process in Harmonization [Seite 60]
11.11 - 2.11 The Special Case of Pharmacopeial Harmonization of Excipients [Seite 61]
11.12 - 2.12 Retrospective versus Forward Pharmacopeial Harmonization [Seite 61]
11.13 - 2.13 Conclusions and Recommendations [Seite 62]
11.14 - 2.14 Final Thoughts [Seite 63]
11.15 - References [Seite 64]
12 - Chapter 3 Common Methods in Pharmaceutical Analysis [Seite 65]
12.1 - 3.1 Scope [Seite 65]
12.2 - 3.2 Analytical Methods [Seite 65]
12.2.1 - 3.2.1 Separation Methods [Seite 65]
12.2.1.1 - 3.2.1.1 High?Performance Liquid Chromatography [Seite 65]
12.2.1.2 - 3.2.1.2 Gas Chromatography [Seite 67]
12.2.1.3 - 3.2.1.3 Thin?Layer Chromatography [Seite 67]
12.2.1.4 - 3.2.1.4 Supercritical Fluid Chromatography [Seite 67]
12.2.1.5 - 3.2.1.5 Capillary Electrophoresis [Seite 68]
12.3 - 3.3 Spectroscopy Methods [Seite 68]
12.3.1 - 3.3.1 Ultraviolet [Seite 68]
12.3.2 - 3.3.2 Infrared [Seite 68]
12.3.3 - 3.3.3 Raman Spectroscopy [Seite 68]
12.3.4 - 3.3.4 Nuclear Magnetic Resonance [Seite 69]
12.3.5 - 3.3.5 Mass Spectrometry [Seite 69]
12.4 - 3.4 Other Spectroscopy Methods [Seite 69]
12.4.1 - 3.4.1 Atomic Absorption Spectroscopy and Inductively Coupled Plasma Spectroscopy [Seite 69]
12.5 - 3.5 Wet Chemistry Methods [Seite 70]
12.5.1 - 3.5.1 Titration [Seite 70]
12.5.2 - 3.5.2 Loss on Drying (LOD) [Seite 70]
12.5.3 - 3.5.3 Loss on Ignition (LOI) [Seite 71]
12.5.4 - 3.5.4 Residue on Ignition (ROI) or Sulfated Ash [Seite 71]
12.5.5 - 3.5.5 Water Determination [Seite 71]
12.6 - 3.6 Performance Methods (Contributed by Oscar Liu) [Seite 71]
12.6.1 - 3.6.1 Disintegration [Seite 71]
12.6.2 - 3.6.2 Dissolution [Seite 72]
12.6.3 - 3.6.3 Uniformity of Dosage Units [Seite 73]
12.6.4 - 3.6.4 Aerodynamic Particle Size Distribution Analysis [Seite 74]
12.7 - 3.7 Microbiological Methods (Contributed by Roger Dabbah) [Seite 75]
12.7.1 - 3.7.1 Introduction [Seite 75]
12.7.2 - 3.7.2 Microbial Limit Tests [Seite 76]
12.7.2.1 - 3.7.2.1 Microbial Limit Tests - Enumeration via a Plate Count [Seite 76]
12.7.2.2 - 3.7.2.2 Membrane Filtration Method [Seite 77]
12.7.2.3 - 3.7.2.3 Most Probable Number (MPN) Procedure [Seite 77]
12.7.3 - 3.7.3 Tests for Specified Microorganisms [Seite 77]
12.7.4 - 3.7.4 Sterility Test [Seite 78]
12.8 - 3.8 Critical Factors Involved in Microbial Limit Tests and in Sterility Tests [Seite 79]
12.9 - 3.9 Harmonization of Pharmacopeial Procedures and Requirement [Seite 80]
12.10 - 3.10 Bacterial Endotoxins Test [Seite 80]
12.11 - 3.11 Summary [Seite 81]
12.12 - References [Seite 82]
13 - Chapter 4 Common Calculations [Seite 86]
13.1 - 4.1 Scope [Seite 86]
13.2 - 4.2 Calculations (Quantitative Analysis) [Seite 86]
13.2.1 - 4.2.1 Percent Loss on Drying (LOD) [Seite 86]
13.2.2 - 4.2.2 Percent Loss on Ignition (LOI) [Seite 87]
13.2.3 - 4.2.3 Percent Residue on Ignition (ROI) [Seite 87]
13.2.4 - 4.2.4 Assay [Seite 87]
13.2.4.1 - 4.2.4.1 Chromatography (HPLC, GC) [Seite 87]
13.2.4.2 - 4.2.4.2 Spectroscopy (UV, IR, etc.) [Seite 89]
13.2.4.3 - 4.2.4.3 Titration [Seite 90]
13.2.5 - 4.2.5 Organic Impurities [Seite 91]
13.2.5.1 - 4.2.5.1 Chromatography (HPLC, GC) [Seite 91]
13.3 - 4.3 Calculations (System Suitability Parameters) [Seite 92]
13.3.1 - 4.3.1 Resolution (R) [Seite 92]
13.3.2 - 4.3.2 Tailing Factor (T) or Asymmetry Factor (As) [Seite 93]
13.3.3 - 4.3.3 Number of Theoretical Plates (N) [Seite 94]
13.3.4 - 4.3.4 Capacity Factor (k?) or Retention Factor (k) [Seite 95]
13.4 - 4.4 Summary [Seite 95]
13.5 - References [Seite 95]
14 - Chapter 5 Analytical Method Validation, Verification, and Transfer [Seite 97]
14.1 - 5.1 Introduction [Seite 97]
14.2 - 5.2 Scope [Seite 97]
14.3 - 5.3 Typical Validation Characteristics [Seite 98]
14.4 - 5.4 Definition and Determination of Analytical Characteristics [Seite 98]
14.4.1 - 5.4.1 Accuracy [Seite 98]
14.4.2 - 5.4.2 Precision [Seite 99]
14.4.2.1 - 5.4.2.1 Repeatability [Seite 99]
14.4.2.2 - 5.4.2.2 Intermediate Precision (Ruggedness) [Seite 99]
14.4.2.3 - 5.4.2.3 Reproducibility [Seite 100]
14.4.3 - 5.4.3 Specificity [Seite 100]
14.4.4 - 5.4.4 Detection Limit (DL) [Seite 101]
14.4.5 - 5.4.5 Quantitation Limit (QL) [Seite 102]
14.4.6 - 5.4.6 Linearity [Seite 103]
14.4.7 - 5.4.7 Range [Seite 103]
14.5 - 5.5 Types of Analytical Procedures [Seite 104]
14.6 - 5.6 Typical Validation Requirement [Seite 104]
14.7 - 5.7 Revalidation [Seite 105]
14.8 - 5.8 System Suitability [Seite 105]
14.9 - 5.9 Forced Degradation (Stressed) Studies [Seite 106]
14.10 - 5.10 Analytical Method Verification [Seite 107]
14.11 - 5.11 Analytical Method Transfer [Seite 109]
14.11.1 - 5.11.1 Comparative Testing [Seite 109]
14.11.2 - 5.11.2 Co?Validation between Labs [Seite 109]
14.11.3 - 5.11.3 Revalidation [Seite 109]
14.11.4 - 5.11.4 Transfer Waiver [Seite 109]
14.12 - 5.12 Summary and Conclusion [Seite 110]
14.13 - References [Seite 110]
15 - Chapter 6 Specifications [Seite 112]
15.1 - 6.1 Scope [Seite 112]
15.2 - 6.2 Introduction [Seite 112]
15.3 - 6.3 Types of Tests [Seite 114]
15.4 - 6.4 Types of Specifications [Seite 115]
15.5 - 6.5 Selection of Tests and Procedures [Seite 117]
15.5.1 - 6.5.1 Universal Tests [Seite 117]
15.5.1.1 - 6.5.1.1 Drug Substances [Seite 118]
15.5.1.2 - 6.5.1.2 New Drug Products [Seite 120]
15.5.2 - 6.5.2 Specific Tests [Seite 122]
15.5.2.1 - 6.5.2.1 Drug Substances [Seite 122]
15.5.2.2 - 6.5.2.2 Drug Products [Seite 123]
15.6 - 6.6 Establishing Acceptance Criteria [Seite 125]
15.6.1 - 6.6.1 Rounding Rules [Seite 125]
15.6.2 - 6.6.2 Statistical Estimation [Seite 126]
15.6.2.1 - 6.6.2.1 Confidence Interval [Seite 128]
15.6.2.2 - 6.6.2.2 Prediction Interval [Seite 128]
15.6.2.3 - 6.6.2.3 Tolerance Interval [Seite 129]
15.6.2.4 - 6.6.2.4 Monte Carlo Simulation of Quality Attributes [Seite 130]
15.6.3 - 6.6.3 Establishing Acceptance Criteria Limits [Seite 130]
15.6.3.1 - 6.6.3.1 Acceptance Criteria for Attributes that Do Not Change with Time [Seite 131]
15.6.3.2 - 6.6.3.2 Acceptance Criteria for Attributes that Change with Time-Trend Analysis [Seite 132]
15.7 - 6.7 Release Specifications [Seite 134]
15.7.1 - 6.7.1 Using the Process Capability Index to Estimate Attribute Acceptance Criteria [Seite 135]
15.8 - 6.8 Relationship between Release and Shelf-Life Specifications [Seite 136]
15.9 - 6.9 Using a Control Chart for Trend Analysis [Seite 138]
15.10 - 6.10 Life Cycle Management of Specifications [Seite 139]
15.10.1 - 6.10.1 Approach to Life Cycle Management [Seite 139]
15.10.2 - 6.10.2 Impact of the Investigation of Out?Of?Specification (OOS) and Out?Of?Trend (OOT) Results on Test Methods and Specifications [Seite 139]
15.11 - 6.11 Summary [Seite 140]
15.12 - Acknowledgments [Seite 141]
16 - Chapter 7 Impurities [Seite 144]
16.1 - 7.1 Scope [Seite 144]
16.2 - 7.2 Definitions [Seite 144]
16.3 - 7.3 Classification of Impurities [Seite 145]
16.4 - 7.4 Qualification of Impurities [Seite 146]
16.5 - 7.5 Other Specific Types of Impurities [Seite 149]
16.6 - 7.6 Non-Drug-Related Impurities [Seite 151]
16.7 - 7.7 Other Sources of Impurities [Seite 151]
16.8 - 7.8 Degradation/Stability Studies [Seite 152]
16.9 - 7.9 Summary [Seite 152]
16.10 - References [Seite 152]
17 - Chapter 8 Good Documentation Practices [Seite 155]
17.1 - 8.1 Scope [Seite 155]
17.2 - 8.2 Definition, Purpose, and Importance [Seite 156]
17.2.1 - 8.2.1 Definition [Seite 156]
17.2.1.1 - 8.2.1.1 ISO Definition and Benefits [Seite 156]
17.2.1.2 - 8.2.1.2 Definition of Document [Seite 157]
17.2.1.3 - 8.2.1.3 Definition of Record [Seite 157]
17.2.1.4 - 8.2.1.4 Definition of Documentation [Seite 157]
17.2.2 - 8.2.2 Purpose of GDocP [Seite 159]
17.2.3 - 8.2.3 Importance of GDocP [Seite 159]
17.3 - 8.3 General Rules and Principles of GDocP [Seite 160]
17.3.1 - 8.3.1 Requirements of Records [Seite 160]
17.3.2 - 8.3.2 General Tips in GDocP [Seite 162]
17.3.2.1 - 8.3.2.1 Time Recording [Seite 163]
17.3.2.2 - 8.3.2.2 Date Recording [Seite 163]
17.3.2.3 - 8.3.2.3 Backdating [Seite 163]
17.3.2.4 - 8.3.2.4 Signature and Initial [Seite 163]
17.3.2.5 - 8.3.2.5 Rounding Rules for Numbers [Seite 164]
17.3.2.6 - 8.3.2.6 Corrections [Seite 164]
17.3.2.7 - 8.3.2.7 Missing Data [Seite 165]
17.3.2.8 - 8.3.2.8 Voiding Records [Seite 165]
17.3.2.9 - 8.3.2.9 Recreating and Rewriting of the Records [Seite 165]
17.3.2.10 - 8.3.2.10 Deviations [Seite 166]
17.4 - 8.4 General Tips for Laboratory Notebook Documentation [Seite 167]
17.4.1 - 8.4.1 Assignment [Seite 167]
17.4.2 - 8.4.2 Documentation [Seite 168]
17.4.3 - 8.4.3 Storage [Seite 170]
17.5 - 8.5 Electronic Documents and Electronic Signatures (21 CFR, Part 11) [Seite 170]
17.5.1 - 8.5.1 Definition of 21 CFR [Seite 170]
17.5.2 - 8.5.2 21 CFR - Subchapter A - General [Seite 171]
17.5.2.1 - 8.5.2.1 Part 11 - Electronic Records and Electronic Signatures [Seite 171]
17.6 - 8.6 US Pharmacopeia General Chapter <1029> [Seite 176]
17.6.1 - 8.6.1 Background [Seite 176]
17.6.2 - 8.6.2 Purpose [Seite 176]
17.6.3 - 8.6.3 Outline of the Chapter [Seite 176]
17.7 - 8.7 Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation) [Seite 177]
17.7.1 - 8.7.1 What is New in the Latest Version? [Seite 177]
17.7.2 - 8.7.2 Outline of EU GDocP Regulations [Seite 178]
17.7.2.1 - 8.7.2.1 Principle [Seite 178]
17.7.2.2 - 8.7.2.2 Required GMP Documentation (by Type) [Seite 178]
17.7.2.3 - 8.7.2.3 Generation and Control of Documentation [Seite 179]
17.7.2.4 - 8.7.2.4 Good Documentation Practices [Seite 180]
17.7.2.5 - 8.7.2.5 Retention of Documents [Seite 181]
17.7.2.6 - 8.7.2.6 Specifications [Seite 181]
17.7.2.7 - 8.7.2.7 Manufacturing Formula and Processing Instructions [Seite 182]
17.7.2.8 - 8.7.2.8 Procedures and Records [Seite 185]
17.8 - 8.8 GDocP Enforcement [Seite 186]
17.8.1 - 8.8.1 Regulatory Bodies in Charge [Seite 187]
17.8.2 - 8.8.2 FDA GDocP Compliance Observations [Seite 187]
17.8.3 - 8.8.3 FDA GDocP Fraud Observations [Seite 188]
17.8.4 - 8.8.4 Excerpts of 483 GDocP Observations [Seite 188]
17.9 - 8.9 Summary [Seite 189]
17.10 - References [Seite 190]
18 - Chapter 9 The Management of Analytical Laboratories [Seite 193]
18.1 - 9.1 Introduction [Seite 193]
18.2 - 9.2 Principles of Management Applicable to the Laboratory Function [Seite 194]
18.2.1 - 9.2.1 System Thinking [Seite 194]
18.2.2 - 9.2.2 Organizational Structure [Seite 194]
18.2.3 - 9.2.3 Accountability and Responsibility [Seite 195]
18.2.4 - 9.2.4 Management of Personnel [Seite 195]
18.2.5 - 9.2.5 Allocation and Utilization of Resources [Seite 195]
18.2.6 - 9.2.6 Internal Interactions [Seite 196]
18.2.7 - 9.2.7 External Interactions [Seite 196]
18.2.8 - 9.2.8 Ethical Behavior [Seite 197]
18.3 - 9.3 Management of Analytical Scientists [Seite 197]
18.3.1 - 9.3.1 Technical Issues Impacting the Management of an Analytical Laboratory [Seite 197]
18.3.1.1 - 9.3.1.1 Selection of Analytical Methods [Seite 197]
18.3.1.2 - 9.3.1.2 All Selected Methods Should Be Validated for Their Intended Purposes [Seite 197]
18.3.1.3 - 9.3.1.3 The International Congress on Harmonization (ICH) Factor [Seite 198]
18.3.1.4 - 9.3.1.4 Management of Analytical Laboratory and cGMPs and GLPs [Seite 198]
18.3.1.5 - 9.3.1.5 Management under International Standardization Organization Certification [Seite 198]
18.3.2 - 9.3.2 Administrative Issues [Seite 198]
18.3.2.1 - 9.3.2.1 Performance Plans and Appraisals [Seite 198]
18.3.2.2 - 9.3.2.2 Training of Personnel and Promotional Opportunities [Seite 199]
18.3.2.3 - 9.3.2.3 Hiring and Firing of Personnel [Seite 199]
18.3.3 - 9.3.3 Managerial Issues in an Analytical Laboratory [Seite 200]
18.3.3.1 - 9.3.3.1 Planning [Seite 200]
18.3.3.2 - 9.3.3.2 Organizing [Seite 200]
18.3.3.3 - 9.3.3.3 Monitoring and Control [Seite 201]
18.3.3.4 - 9.3.3.4 Resolution of Conflicts [Seite 201]
18.4 - 9.4 Conclusions and Recommendations [Seite 202]
18.5 - References [Seite 203]
19 - Chapter 10 Analytical Instrument Qualification [Seite 204]
19.1 - 10.1 Introduction [Seite 204]
19.2 - 10.2 Definitions [Seite 205]
19.3 - 10.3 Qualification: General Flow [Seite 207]
19.4 - 10.4 Qualification Strategy: V Model [Seite 207]
19.5 - 10.5 Qualification [Seite 208]
19.5.1 - 10.5.1 Qualification Scheme for New Equipment [Seite 208]
19.6 - 10.6 Qualification Phases [Seite 211]
19.6.1 - 10.6.1 User Requirement Specification [Seite 211]
19.6.2 - 10.6.2 Impact Assessment [Seite 211]
19.6.3 - 10.6.3 Design Qualification [Seite 212]
19.6.4 - 10.6.4 Factory Acceptance Test (FAT) [Seite 213]
19.6.5 - 10.6.5 Site Acceptance Test (SAT) [Seite 213]
19.6.6 - 10.6.6 Installation Qualification (IQ) [Seite 214]
19.6.7 - 10.6.7 Operational Qualification (OQ) [Seite 215]
19.6.8 - 10.6.8 Performance Qualification (PQ) [Seite 215]
19.6.9 - 10.6.9 Performance Verification (PV) [Seite 216]
19.6.10 - 10.6.10 Requalification [Seite 216]
19.7 - 10.7 Qualification Issues [Seite 216]
19.8 - 10.8 Combined Qualification Approach/Commissioning [Seite 217]
19.9 - 10.9 Risk-Based Approach [Seite 217]
19.10 - 10.10 Calibration/Verification [Seite 217]
19.11 - 10.11 Track Performance Verification/Calibration Due Date [Seite 218]
19.12 - 10.12 Warning Letters Related to Laboratory Equipment [Seite 218]
19.13 - 10.13 Equipment Qualification/Validation and Its Importance [Seite 218]
19.14 - 10.14 Examples [Seite 220]
19.14.1 - 10.14.1 HPLC (High?Performance Liquid Chromatography) [Seite 220]
19.14.2 - 10.14.2 UV/Visible Spectrophotometer [Seite 220]
19.14.3 - 10.14.3 Autotitrator [Seite 229]
19.14.4 - 10.14.4 Karl Fischer Titrators [Seite 229]
19.14.5 - 10.14.5 Weighing Balance [Seite 229]
19.14.6 - 10.14.6 Auto Pipettes [Seite 229]
19.14.7 - 10.14.7 Gas Chromatography [Seite 237]
19.14.8 - 10.14.8 Analytical Column Qualification [Seite 237]
19.14.9 - 10.14.9 Melting Point [Seite 237]
19.15 - 10.15 Qualification Status of Existing Equipment/Instrument [Seite 240]
19.16 - 10.16 Summary [Seite 240]
19.17 - Acknowledgments [Seite 243]
19.18 - References [Seite 243]
20 - List of Abbreviations [Seite 245]
21 - Index [Seite 249]
22 - EULA [Seite 258]

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