DOXPUB 12-0023-SOP

Summary:

Describes how to prepare materials and personnel to enter the cleanroom while minimizing the potential for particulate and microbiological contamination. Applies to personnel utilizing entry vestibules that connect clean and non-clean areas of a GMP facility. Includes provisions for area access and restrictions, vestibule features, personnel practices and equipment preparation.

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 3-page procedure that was actually created and used in the GMP 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:

• Manufacturing Managers
• Material Control Personnel
• Quality Control Personnel