DOXPUB 12-0076-SOP PDF

Summary:

Describes the requirements for providing contract manufacturing services for Customer supplied product. Applies to contract manufacturing services for Customer supplied product. Includes provisions for introductory meetings, contract manufacturing agreements, quality audits, process requirements, statement of work, documentation, ordering services, receiving materials, processing materials, finished product testing, release of materials, invoicing, and customer actions.

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 5-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
• Contract Managers
• Quality Assurance Managers