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Establishing a CGMP Laboratory Audit System: A Practical Guide
Product Description
“Establishing a CGMP Laboratory Audit System: A Practical Guide” is designed to provide laboratory supervisors and personnel with a step-by-step hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future FDA requirements. Focusing on a “team approach” the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system to improve compliance, demonstrate sustainable compliance, product data for FDA inspections and avoid regulatory action. Detailed checklists and forms are provided in a fully modifiable form on a CD-ROM. Hardback text, 291 pages. Not available for download