DOXPUB 12-0062-SOP

Summary:

Provides the procedures for training aseptic processing operators to assure they are capable of performing their required duties. Also provides the outline for job skills training required for aseptic processing operators. Applies to all aseptic processing operators including full-time, part-time, temporary, and contract personnel. Covers training record initiation, training record maintenance, training outline and requirements, and personnel qualificaiton.

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 Training and Qualification

About This Document:

This is not a generic template, it's a 8-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