Quality assurance unit manual

Approved by Each page of the quality manual has a space to provide the name, title, and department of the person in the quality assurance unit or the management representative approving the manual with signatures and the date. 

Program Guidance Manual, 2006), stating Clinical trial quality assurance units (QAUs) are not required by regulation. However, many sponsors have clinical QAUs that perform independent audits/data verifications to determine compliance with clinical trial SOPs and FDA regulations . 

United States Pood and Drug Administration (2006) Drug quality assurance, in FDA Compliance Program Guidance Manual, Ch. 56, United States Food and Drug Administration, pp. 1-28. 

A set procedure for each grade must be set up and strictly adhered to. For normal quality assurance, the weights, temperatures, and times must be logged. The degree of sophistication of each plant can vary from a purely manual system to a computer-controlled, fully automated unit. 

For this study three sites from the UAPSP network that typified different regions and climates of the eastern United States were selected. These sites were Uvalda, GA, in the Southeast, Lancaster, KS, west of the Mississippi River, and Underhill, VT, in the Northeast. Criteria used for site selection for precipitation monitoring are outlined in the U.S. EPA Quality Assurance Manual for Precipitation Measurement Systems (5). 

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