Description
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.
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
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 5
- File Size:
- 1 file , 380 KB
