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This Standard Operating Procedure (SOP) was developed to provide a
comprehensive system and a prescriptive method to ensure that the performance of
all transport containers used to maintain blood or cellular products were
adequately qualified in the manner that they would be used in day-to-day
operations. Prior to the development of this SOP, there was no procedure
addressing either the specific requirements for container qualification or the
methods of performing a container qualification.
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Two other SOPs were developed to address special circumstances. One
SOP described a method of compiling retrospective quality control data to
meet the qualification requirement. The other SOP described the process of
extending the qualification of a container to additional,
"substantially equivalent" uses of the container. Both of these
SOPs included descriptions of the specific requirements as well as forms
to compile the data and document approval.
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This document has been "de-branded" to remove identifying
information.
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