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FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS Laboratory Manual Volume III Section 7Document Number: III07Title:Private Laboratory GuidanceRevision #: 02 Revision Date: 08/13/2019-Page
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ORA laboratory manual volume is a document that provides guidelines and procedures for laboratory testing and analysis conducted by the Office of Regulatory Affairs.
Any laboratory within the Office of Regulatory Affairs that conducts testing and analysis must file an ORA laboratory manual volume.
The ORA laboratory manual volume can be filled out by following the guidelines and templates provided by the Office of Regulatory Affairs.
The purpose of the ORA laboratory manual volume is to ensure consistency and accuracy in laboratory testing procedures.
Information such as standard operating procedures, quality control measures, and test methods must be reported on the ORA laboratory manual volume.
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