DOXPUB 12-0012-SOP PDF

Summary:

Describes the procedures necessary to assign unique lot identification numbers, and ensure traceability of incoming materials, in-process sub-assemblies and final product. Applies to all incoming raw materials, in-process sub-assemblies, and all final product destined for clinical or commercial use. Includes provisions for compliance with 21 CFR Parts 210.3 and 211.80(d).

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 Quality Assurance 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:

• Quality Assurance Managers
• Manufacturing Managers
• Material Control Personnel