DOXPUB 09-0167-SOP PDF

Summary:

Describes a procedure to determine the concentration of protein in solution. Applicable to Bovine Serum Albumin and avidin protein. Applicability to other proteins may be determined on a case by case basis. Intended for measuring the concentration of dilute protein solutions in support of research and development, in process qualifications, cleaning validation studies, and other validations. Employs avidin as a model protein.

Included Sections:

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

Included Attachments/Appendices:

BCA Protein Assay Report Form

About This Document:

This is not a generic template, it's a 4-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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• Use it as a starting point for your own documentation project
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Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel