DOXPUB 02-0028-SOP

Summary:

Describes the gowning procedure for personnel entering the aseptic filling area to minimize the potential for contamination of products. Applies to the gowning performed prior to entering the manufacturing aseptic filling suite to perform aseptic manufacturing and assembly. Procedures for bulk manufacturing gowning are contained in SOP 120002, Clean Room Gowning.

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 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