DOXPUB 03-0012-SOP

Summary:

Describes the processes necessary to install the Gel Production HighwayVIEW Communication Software, User Interface software, PLC software, and manufacturing process files onto the 120 L Reactor system. Covers loading the Highway VIEW Communication Software, Loading the Gel Production PLC Software, loading the gel production user interface software, and loading the manufacturing process files.

Included Sections:

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

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 6-page procedure that was actually created and used in the Bioprocessing 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:

• Biologic Manufacturing Personnel
• Process Development Personnel
• Method Development Personnel