DOXPUB 09-0083-SOP

Summary:

Describes which Device Master Record changes and changes to the Manufacturing facility, utilities, and equipment require FDA notification. Covers the notification process and notification documentation. Applies to changes in product manufacture for FDA regulated products including: device design, manufacturing process, labeling, packaging, facility, raw materials, testing procedure, expiration dating, and specification. Includes provisions for compliance with 21 CFR Parts 314.70 and 314.81.

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 5-page procedure that was actually created and used in the Regulatory Affairs 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:

• Regulatory Affairs Managers
• Quality Assurance Managers
• Manufacturing Managers