DOXPUB 12-0002-SOP

Summary:

Describes the gowning procedure for personnel entering the manufacturing environment to minimize the potential for contamination of products. Applies to gowning performed prior to entering a manufacturing cleanroom for bulk manufacturing and assembly. Does not cover gowning for aseptic filling, which is addressed in SOP 020028 Gowning for Aseptic Filling.

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 2-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