DOXPUB 09-0219-SOP PDF

Summary:

Describes the procedure for keeping accurate inventory of product stability studies. Applies to stability studies of product intended for human use including those from manufacturing, development and feasibility studies, and pilot scale manufacturing. Also applies to stability studies of QC reference standards, and products intended for research use. Covers receipt of stability samples, removal of samples from inventory, testing and data recording, and inventory reconciliation.

Included Sections:

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

Included Attachments/Appendices:

Stability Study Inventory Worksheet

About This Document:

This is not a generic template, it's a 4-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