DOXPUB 12-0020-SOP

Summary:

Describes standardized format, content and style requirements for Manufacturing Batch Records (MBRs). Includes MBR section descriptions, and general style and formatting requirements.

Included Sections:

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

Included Attachments/Appendices:

MBR Master Document Format Template

About This Document:

This is not a generic template, it's a 7-page procedure that was actually created and used in the Document 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:

• Document Control Personnel
• Configuration Management
• GMP Operations Managers