DOXPUB 09-0048-SOP

Summary:

Describes a procedure for the operation of the Beckman HPLC system for size exclusion HPLC analysis (SE-HPLC). Provides a protocol for the proper maintenance and calibration of the Beckman HPLC system. Applies to the preparation of the Beckman HPLC for the analysis of native and biotinylated IgM and IgG, from ascites or tissue culture, by size exclusion chromatography. Covers startup, sample preparation, batch table preparation, data recovery, data archiving, calibration, and routine maintenance.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

HPLC Calibration Worksheet, HPLC Maintenance and Calibration Log Sheet, HPLC User Log, HPLC Column Use Log

About This Document:

This is not a generic template, it's a 12-page procedure that was actually created and used in the Quality Control operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel