DOXPUB 09-0099-SOP

Summary:

Describes a general procedure to determine the bioburden of raw materials, subassemblies and final assemblies. Intended to be used for determination of bioburden levels as well as guidelines for organism characterization in raw materials, subassemblies and final assemblies. Covers general procedures, membrane filtration, pour plates, extraction, and characterization of microorganisms. Includes provisions for compliance with USP 23 (71).

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

About This Document:

This is not a generic template, it's a 7-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