Description
Summary:
Describes the inspection procedure for filled columns, provides a classification system for defect observations, and outlines approved uses for defective columns (salvage). Applies to the inspection of gel filled column assemblies before and after sterilization.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
Defect Observation Descriptions and Codes, Column Inspection Record for Manufacturing, Column Inspection Record for QC, Critical and Non-Critical Defect Designation, Column Salvage Assignment, Column Reconciliation Form
About This Document:
This is not a generic template, it's a 39-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.
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
- Quality Control Personnel
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 39
- File Size:
- 1 file , 680 KB
