Description
Summary:
Describes a procedure to quantitate the concentration of total IgM protein (both immunoreactive and inactive) present in tissue culture supernatant and ascites fluid by size exclusion HPLC. References Beckman HPLC and Gold Nouveau Software v1.0 or equivalent. Applies to the quantitation of monoclonal IgM from tissue culture supernatant, ascites fluid, purified bulk, and vialed preparations of IgM. Covers data reporting, system suitability testing, procedures and documentation requirements.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
IgM Quantitation Report FormTest
About This Document:
This is not a generic template, it's a 7-page procedure that was actually created and used in the Quality Control 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:
- Quality Assurance Managers
- Manufacturing Managers
- Quality Control Personnel
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 7
- File Size:
- 1 file , 380 KB
