Summary:

Describes a method of assuring the identity and fitness for use of materials used in the manufacturing process. Applies to all materials procured from external vendors used to manufacture and package product. Does not apply to materials manufactured internally. Refers to SOP 090041, Manufactured Material QA Procedure. Material is sampled according to SOP 090074, QC Sampling Techniques, and as specified in appropriate PNS.

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 Quality Assurance 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:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel