DOXPUB 09-0209-SOP

Summary:

Provides a procedure for verifying the Sterility Test Suite Rooms as an appropriate sterile testing environment. Also provides the procedures for general use of the Sterility Test Suite and environmental monitoring requirements during use of Rooms and for testing purposes. Applies to QA/QC testing use of Sterile Test Suite Rooms and where aseptic manipulations and maintenance of sterility are required.

Included Sections:

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

Included Attachments/Appendices:

Sterile Test Area Entry Logsheet, Sterility Test Environmental Monitoring Results

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