This reference teaches proper procedures for using tools and analytical methods in a regulated lab setting.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions.

Coverage includes:

• Method validation of potency, related substances, and dissolution testing
• Validation for pharmaceutical excipients, heavy metals, and bioanalysis
• Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters
• The LCMS system calibration
• Proper environmental chamber qualification
• Entire qualification process for computer equipment, hardware, and software
• Validation of Excel spreadsheets
• Regulatory requirements of the FDA, ICH, Europe, and Japan

Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment.

Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibration scientists, and research and development scientists.

Contents

1. Overview of the Pharmaceutical Product Development and Its Associated Quality System
2. Potency Method Validation
3. Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products
4. Dissolution Method Validation
5. Development and Validation of Automated Methods
6. Analysis of Pharmaceutical Inactive Ingredients
7. Validation Study of JP Heavy Metal Limit Test
8. Bioanalytical Method Validation
9. Procurement, Qualification, and Calibration of Laboratory Instruments: An Overview
10. Performance Varification of UV - Vis Spectrophotometers
11. Performance Verification of HPLC
12. Operational Qualification of a Capillary Electrophoresis Instrument
13. LC-MS Instrument Calibration
14. Karl Fisher Apparatus and Its Performance Verification
15. The pH Meter and Its Performance Verification
16. Qualification of Environmental Chambers
17. Equipment Qualification and Computer System Validation
18. Validation of Excel Spreadsheet

Index

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