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Noven Gets 483 on Cleaning, Qualification, Mapping

September 24, 2010
Noven Pharmaceuticals’ swab sampling procedure lacked adequate instructions to consistently perform the procedure after cleaning shared equipment, according to a recent Form 483.

The Miami company’s instructions did not specify direction and pattern of swabbing, the form says.

Additionally, the manufacturing process for Daytrana (methylphenidate) patches does not produce finished product that consistently meets mechanical peel force specifications through its shelf life, the form says.
Drug GMP Report