DOXPUB 09-0084-SOP

Summary:

Describes procedures for addressing out-of-specification quality testing results. Applies to lot release testing performed by QC personnel on product or components made by Manufacturing. Also applies to testing performed by QA/QC personnel in support of stability studies on product, and to testing performed by QC personnel on raw materials procured from outside vendors. Does not apply to environmental monitoring performed in facility, or to other monitoring of facilities and utilities.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

QC Test Failure Reporting Form, QC Test Failure Logsheet

About This Document:

This is not a generic template, it's a 6-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