DOXPUB 09-0032-SOP PDF

Summary:

Provides the procedure for detecting endotoxin levels in aqueous solutions using Limulus Amebocyte Lysate (LAL) gel clot method. Includes provisions for sample handling, endotoxin control, operation, reading reactions, calculating results, reagent qualification and extraction.

Included Sections:

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

Included Attachments/Appendices:

LAL Test Results Worksheet

About This Document:

This is not a generic template, it's a 5-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