DOXPUB 12-0040-SOP

Summary:

Describes the requirements for equipment cleaning and use logbooks in compliance with Good Manufacturing Practices. Applies to all critical or major equipment used in the manufacture or testing of products intended for commercial or clinical distribution. Includes provisions for compliance with 21 CFR Part 820.60.

Included Sections:

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

Included Attachments/Appendices:

Equipment Cleaning and Use Logsheet

About This Document:

This is not a generic template, it's a 3-page procedure that was actually created and used in the Quality Assurance 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
• Facilities Managers
• Material Control Personnel