DOXPUB 09-0042-SOP PDF

Summary:

Describes a procedure for performance testing and growth promotion on media used for QC microbial tests. Applies to all media used for microbial testing including environmental monitoring, sterility testing, and bioburden determinations. Includes provision for compliance with USP 23-NF 18 <71>.

Included Sections:

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

Included Attachments/Appendices:

Growth Promotion Test Chart, Growth Promotion Test Report

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