DOXPUB 09-0231-SOP

Summary:

Provides procedure for functional performance testing of cryopreservation bags for cell-based products. Also provides test forms for recording the functional test results for lot release and stability testing. Applicable to the functional performance testing of the Cryopreservation bag for lot release testing, stability testing, and development.

Included Sections:

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

Included Attachments/Appendices:

Cryopreservation Bag Functional Test Report Form

About This Document:

This is not a generic template, it's a 4-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