DOXPUB 12-0021-SOP PDF

Summary:

Describes the procedures for rework and reprocessing operations, including the procedures necessary to ensure that causes for all rework or reprocessing operations are investigated so that changes can be identified and implemented to prevent future process failures. Applies to the reworking of drug, biologic and medical device products. Also applies to the reprocessing of batches that do not conform to specifications. Includes provisions for determining whether rework/reprocess is appropriate, and execution of approved rework/reprocess orders.

Included Sections:

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

Included Attachments/Appendices:

Rework Or Reprocessing Instructions, QC Inspection Services Request and Lot Summary

About This Document:

This is not a generic template, it's a 7-page procedure that was actually created and used in the GMP 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:

• Manufacturing Managers
• Material Control Personnel
• Quality Control Personnel