DOXPUB 09-0002-SOP
standard published 08/01/2007 by Doxpub, Inc.
standard published 08/01/2007 by Doxpub, Inc.
Summary:
Describes a program for monitoring the water system of the Manufacturing Facility that will demonstrate routine compliance with pre-determined water quality criteria. Applies to the following utilities: DI water system, WFP system, Clean steam system. Includes provisions for compliance with USP 23-NF-18, USP (788) and FDA's "Guide to Inspections of High Purity Water Systems."
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 Quality Control 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:
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