Full Description

Summary:

Describes the general requirements for control of biologic, medical device and drug manufacturing processes. Identifies general requirements and documentation for manufacturing plans, change controls, environmental and equipment controls, critical manufacturing processes and process flow charts.

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 projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doing

Who Will Benefit:

Manufacturing ManagersMaterial Control PersonnelQuality Control Personnel

Product Details:

Edition: 1.0 Published: 08/01/2007 Number of Pages: 3