Summary:

Describes the procedures and flow of operations in aseptic processing areas used to manufacture sterile products. Applicable to sterile products manufactured in an Aseptic Filling Room. Includes provisions for entry gowning room entry, aseptic fill room entry, and aseptic filling practices.

Included Sections:

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

Included Attachments/Appendices:

Aseptic Filling Area Entry Logsheet

About This Document:

This is not a generic template, it's a 1-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