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Analytical chemistry in a GMP environment : a practical guide / edited by James M. Miller, Jonathan B. Crowther.

Contributor(s): Miller, James M, 1933- | Crowther, Jonathan B.
Material type: materialTypeLabelBookPublisher: New York : Wiley, c2000Description: xviii, 488 p. : ill. ; 25 cm.ISBN: 0471314315 (cloth : alk. paper); 9780471314318.Subject(s): Drugs -- Analysis -- Quality control | Pharmaceutical chemistry -- Quality control | Manufacturing industries | Chemistry | Analytical chemistry | Pharmaceutical chemistry & technology | Health and WellbeingDDC classification: 615.190685 ANA | 615.190685 Summary: This text provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies.
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Item type Current library Call number Copy number Status Barcode
General lending MTU Bishopstown Library Lending 615.190685 (Browse shelf(Opens below)) 1 Available 00079080
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Enhanced descriptions from Syndetics:

How to hone your analytical skills and obtain high-quality data in the era of GMP requirements
With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features:
* The drug development process in the pharmaceutical industry
* Uniform and consistent interpretation of GMP compliance issues
* A review of the role of statistics and basic topics in analytical chemistry
* An emphasis on high-performance liquid chromatographic (HPLC) methods
* Chapters on detectors and quantitative analysis as well as data systems
* Methods for ensuring that instruments meet standard operating procedures (SOP) requirements
* Extensive appendixes for unifying terms, symbols, and procedural information

Includes bibliographical references and index.

This text provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies.

CIT Module CHEM 8004 - Supplementary reading

Table of contents provided by Syndetics

  • Contributors (p. xix)
  • Foreword (p. xxi)
  • Preface (p. xxiii)
  • 1 The Laboratory Analyst's Role in the Drug Development Process (p. 1)
  • 1.1. Introduction (p. 1)
  • 1.2. Requirements of an Analytical Methodology During the Drug Development Process Release and Stability (p. 5)
  • 1.3. The Analyst Role in Formulations Development (p. 12)
  • 1.4. Review of the Analyst Role in Pharmacokinetics, Toxicology, and Clinical Support (p. 15)
  • 1.5. Stability Program in Pharmaceutical Industry (p. 23)
  • 1.6. Chapter Summary (p. 28)
  • References (p. 29)
  • 2 Laboratory Controls and Compliance (p. 31)
  • 2.1. Introduction (p. 31)
  • 2.2. Laboratory Management (p. 33)
  • 2.3. Laboratory Controls (p. 35)
  • 2.4. Laboratory Compliance (p. 42)
  • 2.5. Conclusion (p. 47)
  • References (p. 47)
  • 3 The USP, ICH, and Other Compendial Methods (p. 49)
  • 3.1. Introduction (p. 49)
  • 3.2. USP/NF (p. 49)
  • 3.3. European, British, Japanese Pharmacopeias (p. 56)
  • 3.4. ICH Guideline (p. 59)
  • 3.5. Conclusion (p. 74)
  • References (p. 75)
  • 4 Statistics in the Pharmaceutical Analysis Laboratory (p. 77)
  • 4.1. Errors Associated with Making Measurements (p. 78)
  • 4.2. Significant Figures and Rounding (p. 79)
  • 4.3. Some Definitions (p. 84)
  • 4.4. Normal Distribution of Repeated Measurements (p. 91)
  • 4.5. Student t Test (p. 92)
  • 4.6. Propagation of Uncertainty (Errors) (p. 95)
  • 4.7. Rejection of Outliers (p. 97)
  • 4.8. Linear Regression Analysis (p. 98)
  • 4.9. Quality Assurance/Control (p. 99)
  • 4.10. Conclusion (p. 102)
  • References (p. 102)
  • 5 Basic Analytical Operations and Solution Chemistry (p. 105)
  • 5.1. Analytical Reagents (p. 105)
  • 5.2. Sampling (p. 107)
  • 5.3. Chemical Equilibrium (p. 112)
  • 5.4. Aqueous Solution Equilibria (p. 120)
  • 5.5. Reduction-Oxidation Equilibria (p. 124)
  • 5.6. Karl Fischer Titration (p. 141)
  • 5.7. Other Methods for Determining Water (p. 144)
  • 5.8. Miscellaneous Techniques (p. 145)
  • References (p. 146)
  • 6 Spectroscopy (p. 149)
  • 6.1. The Electromagnetic Spectrum (p. 149)
  • 6.2. Wave-Particle Duality (p. 149)
  • 6.3. Transitions and Energies (p. 151)
  • 6.4. Ultraviolet/Visible Spectroscopy (p. 153)
  • 6.5. Infrared Spectroscopy (p. 156)
  • 6.6. Beers Law and Quantitative Analysis (p. 161)
  • 6.7. Instrumentation (p. 163)
  • 6.8. Raman Spectroscopy (p. 177)
  • 6.9. Near-IR (NIR) Spectroscopy (p. 180)
  • 6.10. Other Optical and Spectroscopic Techniques (p. 181)
  • 6.11. Summary (p. 184)
  • General References (p. 184)
  • 7 Chromatographic Principles (p. 185)
  • 7.1. Definitions, Terms, and Symbols (p. 185)
  • 7.2. Comparison of GC and LC (p. 198)
  • 7.3. Two Important Fundamentals (p. 199)
  • 7.4. Some Additional Terms (p. 212)
  • 7.5. Summary (p. 215)
  • References (p. 216)
  • 8 Gas Chromatography (p. 217)
  • 8.1. Some Historical Notes (p. 217)
  • 8.2. Advantages and Disadvantages (p. 218)
  • 8.3. Classification of GC (p. 219)
  • 8.4. Columns (p. 220)
  • 8.5. Other Instrument Components (p. 226)
  • 8.6. Temperature Considerations (p. 241)
  • 8.7. Optimization and Method Development (p. 248)
  • 8.8. Some Special Topics (p. 249)
  • 8.9. Applications (p. 251)
  • References (p. 252)
  • 9 Liquid Chromatography: Basic Overview (p. 255)
  • 9.1. Introduction (p. 255)
  • 9.2. Column Methods (p. 261)
  • 9.3. Planar Methods: TLC and PC (p. 268)
  • 9.4. USP (p. 270)
  • 9.5. Instrumentation for HPLC (p. 270)
  • 9.6. Capillary Electrophoresis (CE) (p. 279)
  • References (p. 281)
  • 10 HPLC Column Parameters (p. 283)
  • 10.1. Column Equivalency (p. 284)
  • 10.2. Review of Chromatographic Parameters (p. 285)
  • 10.3. Parameters Necessary for Equivalent Columns (p. 287)
  • 10.4. Column Efficiency (p. 295)
  • 10.5. Putting It All Together--Selecting an Equivalent Column (p. 302)
  • References (p. 307)
  • 11 Dissolution (p. 309)
  • 11.1. Introduction (p. 309)
  • 11.2. Dissolution Basics (p. 311)
  • 11.3. USP/NF Pharmacopeia General Chapter [711] (p. 315)
  • 11.4. Measurement of the Pharmaceutical Active (p. 326)
  • 11.5. Analyst Checklist (p. 328)
  • References (p. 328)
  • 12 Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (p. 331)
  • 12.1. Background (p. 331)
  • 12.2. Introduction (p. 332)
  • 12.3. The Method Development Life Cycle--Overview (p. 338)
  • 12.4. Planning (p. 338)
  • 12.5. Method Development--General Considerations (p. 347)
  • 12.6. Documentation (p. 351)
  • 12.7. Method Development--Experimental Considerations (p. 353)
  • 12.8. Validation Activities (p. 361)
  • 12.9. Analytical Method Transfer (p. 363)
  • 12.10. Periodic Review (p. 364)
  • 12.11. Reference Standards and Samples to Support Stability Indicating Method Development (p. 365)
  • 12.12. Summary (p. 368)
  • References (p. 369)
  • 13 Some Principles of Quantitative Analysis (p. 371)
  • 13.1. Detector Classifications (Chromatographic) (p. 372)
  • 13.2. Detector Characteristics (p. 375)
  • 13.3. Methods of Quantitative Analysis (p. 385)
  • 13.4. Additional Topics (p. 392)
  • References (p. 392)
  • 14 Laboratory Data Systems (p. 395)
  • 14.1. Introduction (p. 395)
  • 14.2. Laboratory Information Management Systems (LIMS) (p. 397)
  • 14.3. Chromatography Data Systems (p. 401)
  • 14.4. Analog-to-Digital (A/D) Conversion (p. 403)
  • 14.5. CDS Workflow (p. 412)
  • 14.6. Concluding Remarks (p. 420)
  • References (p. 420)
  • 15 Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (p. 423)
  • 15.1. Introduction (p. 423)
  • 15.2. Instrument Qualification (p. 424)
  • 15.3. Instrument Qualification Process--Assembly of the Qualification Team (p. 429)
  • 15.4. The Qualification Protocol (p. 429)
  • 15.5. IQ Protocol (p. 430)
  • 15.6. Instrument Qualification Summary (p. 435)
  • 15.7. Analytical Method Validation (p. 435)
  • 15.8. A Systematic Approach to Validation Experimentation (p. 441)
  • 15.9. Chapter Summary (p. 456)
  • References (p. 457)
  • Appendixes
  • I List of Symbols and Acronyms (p. 459)
  • II Glossary of Terms Used in ICH Documents (p. 467)
  • III Universal Tests, Dosage-Form-Specific Tests, and Acceptance Criteria (p. 473)
  • IV USP Chromatographic Phases (p. 477)
  • Index (p. 483)

Author notes provided by Syndetics

JAMES M. MILLER, PhD, is Emeritus Professor of Chemistry, Department of Chemistry, Drew University, Madison, New Jersey.
JONATHAN B. CROWTHER, PhD, is Director of Analytical Services and Systems at the Janssen Research Foundation, a division of Johnson & Johnson.