Summary:

Provides the procedure for cleaning and sanitizing difficult to clean locations and equipment to control particulate and microbial contamination. Applies to drug, biologic and device manufacturing cleanrooms and support areas. Includes provisions for scheduling, performing and documenting cleaning activities.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Room Cleaning and Sanitization Logsheet, Example Layout Drawing Building Cleanrooms and Support Areas

About This Document:

This is not a generic template, it's a 6-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