DOXPUB 09-0108-SOP PDF

Summary:

Describes a procedure for determining carboxyl groups on polyacrylamide gel matrix materials. Applies to testing performed by QA/QC, R&D, and other laboratory personnel. Intended for lot release, stability, validation, development and other gel testing as required. Covers reagent preparation, test preparation, gel sample preparation, tritration, calculations and data reporting.

Included Sections:

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

Included Attachments/Appendices:

Carboxyl Assay Worksheet

About This Document:

This is not a generic template, it's a 5-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.

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Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel