DOXPUB 09-0225-SOP

Summary:

Describes the procedures and guidelines for review of Quality Control and Quality Assurance data, and for determining the validity of data generated during testing and inspection performed by Quality Control and Quality Assurance. Applies to testing and inspection data used for lot release of finished product and in-process materials, QA/QC testing and inspection records used to support stability studies, method validations, product development studies, and QA/QC investigations, and to QA/QC test data generated to monitor water and environment. Also applies to testing and inspection data used for release of purchased parts, chemicals, etc. intended for use in product, and to QA/QC equipment use and calibration data generated by QA/QC personnel.

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 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
• Manufacturing Managers
• Quality Control Personnel