DOXPUB 15-0040-SOP

Summary:

Describes how to prepare a growth factor supplement mixture for addition to MethoCult H4230. Applies to the preparation of a batch lot of growth factor supplement mixture for use with MethoCult H4230. Applies to growth factor supplements used at clinical sites by the Clinical group and in house by Research & Development (R&D) as a standard assay for CFC analysis of bone marrow or PBPC samples. Covers initiating the procurement of all reagents and for the coordination of other groups [i.e. Research and Development(R&D), Manufacturing], preparation of supplement mixture and for proper storage of vials, filling and labeling of vials, and handling and shipment of vials to clinical sites.

Included Sections:

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

Included Attachments/Appendices:

Growth Factor Supplement Preparation for Methocult H4229

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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