DOXPUB 09-0252-SOP

Summary:

Describes how to qualify new lots of tissue culture media by screening for their ability to support cell growth, such as JRH Excell-300-MBS. Applicable when determining whether an incoming lot of tissue culture media should be accepted for use in manufacturing. Covers growth studies, cell counting, viability determination, and interpretation of data.

Included Sections:

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

Included Attachments/Appendices:

Growth Study Log Sheet, Media Testing Report Form

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