DOXPUB 12-0074-SOP
standard published 08/01/2007 by Doxpub, Inc.
standard published 08/01/2007 by Doxpub, Inc.
Summary:
Describes the gowning procedure for personnel entering the tissue culture production areas to minimize the potential for contamination of products. Applies to the gowning performed prior to entering tissue culture production cleanroom and tissue culture development cleanrooms.
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 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.
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