DOXPUB 09-0240-SOP

Summary:

Describes procedures of performing bacteriostasis and fungistasis test for validating a product sterility test method. Applicable to all articles that are tested for sterility where determination of bacteriostasis and fungistasis levels are required as specified in individual operating procedures, and/or pH armacopoeias. Also applies to bulk and final containers where the bulk volume is at least 10 mL and final containers are less than 10 mL, and to to finished products or devices where bacteriostasis/fungistasis tests are required. Includes provisions for compliance with USP 23-NF 18 <71>, European Pharmacopoeia 3rd Supp., and 21 CFR Part 610.12(e)(2)(vi).

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 Bacteriostasis/Fungistasis Test, and Membrane Filtration Bacteriostasis/Fungistasis Test

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