DOXPUB 09-0116-SOP

Summary:

Describes a testing procedure for determining bioburden in water samples collected from facilities. Applies to WFP, Clean Steam, DI, or other water testing ports as needed that are located facilities. Specific procedures for collecting water samples are addressed in SOP 090002. Covers sample processing, counting and recording, and characterizations of microorganisms.

Included Sections:

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

Included Attachments/Appendices:

Bioburden Test Report Form, Bioburden Test Results Form

About This Document:

This is not a generic template, it's a 6-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