GMP sterility testing

Henry Wolfe (hnwo@americas.nycomed.com)
Tue, 10 Nov 1998 11:26:20 -0700

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We are trying to bring our microbiology clean room online and have only
one microbiologist in house. She was qualified for sterility testing in such
a room at RPR, but the other microbiologist never qualified her before he
left for another job. Any ideas what we can do to qualify the
microbiologist and the room? Can we set up a protocol to self-qualify, or
is there some way (i.e. a consultant) to get both this microbiologist and
the room qualified?

Hank Wolfe
Nycomed Amersham
Wayne, Pa (USA)

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