DOXPUB 16-0005-SOP

Summary:

Describes general guidelines for maintaining a continuous supply of human tumor cells for use as positive controls in immunostaining tests for the detection of micrometastases. Applies to all laboratory personnel who maintain human tumor cell lines for use in immunoytochemical analyses.

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 3-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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• Use it as a starting point for your own documentation project
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Who Will Benefit:

• Process Development Personnel
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