DOXPUB 09-0053-SOP

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