DOXPUB 09-0039-SOP

Summary:

Describes a method for sterility testing small volume liquid articles by direct inoculation. Applies to liquid articles requiring sterility testing that are manufactured or received by where the fill volume per unit is less than 10 mL, as well as articles examined for receiving inspection sterility. Also applies to articles classified as ¿biologics¿ and tested per the requirements of 21 CFR 610.12 direct transfer sterility test methods. Includes provisions for compliance with Eighth Supplement of USP 23-NF 18.

Included Sections:

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

Included Attachments/Appendices:

Direct Inoculation Sterility Test Report

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
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• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel