DOXPUB 09-0005-SOP

Summary:

Describes a procedure to be followed by personnel who have contact with inspectors from the Food and Drug Administration. Applies to all visits by FDA inspectors. Covers general background of inspections, greeting the inspector, setting the agenda with the inspector, accompanying the inspector, items that the inspector has access to, refusal of requests, affidavits signed by employees upon request, exit interviews, and followup actions. Addresses section 704 of the Federal Food, Drug and Cosmetic Act of 1938.

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 6-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
• Management Representatives
• Executive Management