Summary:

Describes the good documentation practices necessary to ensure an accurate and legible record of all work performed in GMP regulated activities. Applies to all GMP required records including, but not limited to, completed Manufacturing Batch Records, Part Number Specifications, Qualification and Validation Records, Equipment Maintenance and Calibration Records, Discrepancy Reports and Material and Cost Transfer forms (MCT). Includes provisions for handwritten signatures and data entries, determining significant figures, and rounding off figures and results.

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 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
• Quality Assurance Managers
• GMP Operations Managers