DOXPUB 09-0210-SOP

Summary:

Describes a procedure for performing an investigation of a Sterility Test failure on aseptically filled and terminally sterilized products. Applicable to investigations of sterility test failures in aseptically filled and terminally sterilized products tested by Quality Control Department or tested by outside contractor services. Covers investigation, interpretation of results, and repeat test procedures. Detailed investigation form included.

Included Sections:

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

Included Attachments/Appendices:

Sterility Test Failure Investigation Record

About This Document:

This is not a generic template, it's a 8-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