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GMP inspections of active-compound makers could be requested by EDQM from the context on the CEP certification scheme.The MIA holder to blame for QP certification should really make sure all functions in a “chain of contracts” set up are audited and evaluated According to the necessities talked about in EU GMP Chapter seven and Annex sixteen.Do
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(h) Printing equipment on, or connected to, manufacturing lines accustomed to imprint labeling upon the drug solution device label or scenario shall be monitored to guarantee that all imprinting conforms on the print laid out in the batch output document.Important weighing, measuring, or subdividing functions ought to be witnessed or subjected to a
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