Description
Summary:
Describes a protocol for assessing the long term stability of filled avidin solution, 4.5 mL. Applicable to avidin solution, filled at 4.5 mL ( P/N ) intended for clinical, research, or commercial use. Covers lot selection, product evaluation, stability test failure, and documentation.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
Avidin Solution Stability Test Requirements & Calendar, Avidin Solution Stability Test Point Summary
About This Document:
This is not a generic template, it's a 5-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:
- 5
- File Size:
- 1 file , 310 KB
