DOXPUB 09-0002-SOP PDF

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:

• 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:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel