DOXPUB 09-0212-SOP

Summary:

Describes procedures for qualifying new lots of reagents used in ELISA-based test methods. Intended to provide a system for maintaining a record of the current lot and dilution or concentration of immunoreagents used in all QC ELISA assays. Applicable to the evaluation of ELISA reagents for Capture antibodies, as well as secondary, or enzyme-conjugated antibodies Also applicable to ELISA test methods conducted in the quality control laboratory. Covers evaluation of a new lot of capture antibody, titration of new lots of capture antibody, evaluation of a new lot of secondary enzyme-linked antibody, and titration of the new lot of secondary antibody.

Included Sections:

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

Included Attachments/Appendices:

Elisa Reagent Log Sheet, Qualification worksheet for New Lots of Elisa Reagents

About This Document:

This is not a generic template, it's a 7-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