DOXPUB 09-0041-SOP

Summary:

Describes the method for assuring the identity and fitness for use of manufactured materials. Applies to all materials manufactured by for use internally, clinical research, and for those intended for commercial sale. Does not apply to materials procured from external sources (see SOP-09-0003). Covers sampling, quarantine labeling, notifying QC, QC inspection and testing, acceptance handling and labeling, rejection handling and labeling, and recordkeeping.

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