DOXPUB 09-0093-SOP

Summary:

Describes a procedure to qualify technicians for testing in, and materials for testing by the LAL Gel-Clot method for endotoxin determination. Applies to all persons performing endotoxin testing by LAL Gel-Clot, and all materials, reagents and products that require endotoxin determination by the LAL Gel-Clot method. Covers analyst qualification and inhibition/enhancement test.

Included Sections:

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

Included Attachments/Appendices:

Endotoxin Inhibition/Enhancement Test For, Lal Gel-Clot Analyst Qualification Form

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