DOXPUB 16-0003-SOP PDF

Summary:

Provides procedures to assure that specimens submitted to the laboratory for immunocytochemical analysis are processed in a manner that optimizes conditions for the detection of micrometastatic tumor cells. Includes instructions for processing frozen samples, paraffin-embedded specimens, blood product specimens, and invalid specimens.

Included Sections:

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

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Laboratory R&D 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.

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Who Will Benefit:

• Process Development Personnel
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