DOXPUB 15-0027-SOP

Summary:

Describes a method of evaluating the effects of liquid samples on the growth of mammalian cells in culture. Includes a method to determine if liquid samples are cytotoxic to mammalian cells. Suitable for testing liquid materials to determine the cytotoxic effects on mammalian cells. Also suitable for determining the effects of soluble materials on the growth of mammalian cells in culture. Includes instructions for preparing test samples, analyzing plates, reporting data, and grading and interpreting results.

Included Sections:

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

Included Attachments/Appendices:

Cytotoxicity Report Form

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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