DOXPUB 09-0182-SOP

Summary:

Provides guidelines for performing package drop and vibration tests per ISTA Project 1A. Applicable to all package drop and vibration testing per Product Packaging Validation Master Plan. Covers labeling, photodocumentation, drop testing, and vibration testing.

Included Sections:

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

Included Attachments/Appendices:

34-Page Packaging Validation Master Plan for Device and Instrument Products

About This Document:

This is not a generic template, it's a 34-page procedure that was actually created and used in the Validation 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:

• Validation Personnel
• Quality Assurance Managers
• Manufacturing Managers