DOXPUB 09-0088-SOP

Summary:

Describes methods for retaining reserve samples of appropriate lots of product and related materials, and for obtaining, identifying, storing and documenting appropriate information as it applies to retention samples from each lot. Applies to retention samples of finished goods and certain subassemblies. Also applies to retention samples of chemical and other raw materials received for use in product and subassemblies. Includes provisions for compliance with 21 CFR Part 211.170.

Included Sections:

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

Included Attachments/Appendices:

Retention Sample Logsheet for Manufacturer Parts, Retention Sample Logsheet for Purhcase Parts

About This Document:

This is not a generic template, it's a 5-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