standard published 08/01/2007 by Doxpub, Inc.
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 projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:
Manufacturing ManagersMaterial Control PersonnelQuality Control Personnel
