DOXPUB 16-0006-SOP

Summary:

Describes a procedure to assure proper quality assurance of all specimen receiving, processing, immunostaining, and interpretation procedures performed in the laboratory. Also covers monthly QA testing and sampling. Applies to laboratory personnel who handle, process, immunostain, or interpret the results of patient specimens.

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 3-page procedure that was actually created and used in the Laboratory R&D 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:

• Process Development Personnel
• Method Development Personnel
• Quality Control Personnel