DOXPUB 09-0188-SOP

Summary:

Describes procedures for documenting receipt of samples to be tested by QA/QC and identifying QA/QC samples during 'on test' status. Applicable to lot release, stability, receiving inspection, method validation, and other samples being tested by QA/QC personnel. Also applies to all samples brought into the QC laboratory for testing purposes. Does not apply to microbiological samples obtained during environmental monitoring, or QC retention samples. Covers consecutive number identification labeling, using the sample receipt log, and sample handling and disposal.

Included Sections:

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

Included Attachments/Appendices:

Sample Receipt Log Example, QC Testing Request Form

About This Document:

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