DOXPUB 15-0026-SOP

Summary:

Describes a method to determine the cytotoxic effects of extracts from solid materials on the growth of mammalian cells in culture. Suitable for testing medical device components and for determining the effects of soluble materials on the growth of mammalian cells in culture. Includes instructions for preparing test samples, incubating and running samples, analyzing plates, and recording and interpreting data.

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.

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:

• Process Development Personnel
• Method Development Personnel
• Quality Control Personnel