DOXPUB 15-0041-SOP PDF

Summary:

Provides a method to test prepared growth factor supplement mixture and MethoCult H4230 for ability to stimulate growth of colony forming units (CFC). Applies to the CFC testing of supplement mixture when to MethoCult H4230. Also applies to testing stability of supplement mixture and demonstrating equivalence of new supplement batches to previously released ones using the CFC assay. Includes instructions for CFC setup, progenitor enumeration, and MethoCult batch acceptance criteria.

Included Sections:

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

Included Attachments/Appendices:

Analysis of CFC Assay Results, Colony-Forming -Unit Worksheet, Thaw Worksheet

About This Document:

This is not a generic template, it's a 8-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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