DOXPUB 09-0113-SOP PDF

Summary:

Describes a procedure for the detection and/or quantitation of rat IgG immunoglobulin in undefined preparations. Suitable for testing materials used in the production of parenteral solutions and biologics. Also suitable for for in-process testing of hybridoma secreted products in ascities fluid, tissue culture supernatants or in purified form.

Included Sections:

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

Included Attachments/Appendices:

None

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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Who Will Benefit:

• Quality Assurance Managers
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