Summary:

Provides standardized guidelines for designing and implementing a method validation protocol. Applies to analytical methods used for lot release and stability testing. Includes provisions for precision, ruggedness, accuracy, limit of quantitation and linearity, limit of detection, results reporting and method transfer.

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 8-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