DOXPUB 09-0134-SOP

Summary:

Describes procedures for performing the chemistry tests stated in the current United States Pharmacopeia (USP) monograph for Purified Water: pH, chloride, sulfate, ammonia, calcium, carbon dioxide, heavy metals, oxidizable substances and total solids. Applies to routine testing of samples from the critical water and steam systems in the Manufacturing Facility including deionized water, water for production, and clean steam.

Included Sections:

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

Included Attachments/Appendices:

Total Solids Worksheet, USP Chemistry Reporting Form

About This Document:

This is not a generic template, it's a 10-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