Description
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
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 3
- File Size:
- 1 file , 290 KB
