DOXPUB 10-0005-SOP PDF

Summary:

Describes the procedure for receiving and handling human tissue specimens. Applicable to all samples received from outside sources (e.g. clinical sites, collaborations, contracted suppliers). Includes provisions for buffy coats, bone marrow, apheresis products, serum, genetic material and cord blood. References SOP 120034, Biohazard Exposure Control Plan.

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 Material 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:

• Material Control Personnel
• Manufacturing Managers
• Quality Assurance Managers