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in-process materials
you must wear clean
and signed
to ensure uniformity in every finished batch and that it meets its specification
You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine that specifications are met
USP 62 Absence of Enterobacter fungi in-process materialsProcedure and report form for the absence of Enterobacteria coliforms in products according to the principles of harmonized method USP <62> and EP 2. 6. 13
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