Summary:

Describes the general guidelines for demonstrating the fitness for use of designs, methods, procedures, processes and equipment. Applies to all designs, methods, procedures, processes and equipment used to manufacture products. Qualification of suppliers is addressed in SOP 090010, Supplier Qualification and Auditing Procedure. Covers validation documentation requirements, activity sequencing and prioritization, recertification, requalification, and revalidation.

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 7-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