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An Italian Medicines Agency (AIFA) inspection of an Iason Italia radiopharmaceuticals plant in Rome has resulted in a GMP non-compliance statement, published in the EU’s EudraGMDP database. The October 2015 inspection reported three critical deficiencies, eleven major deficiencies, and five minor. The report notes that the “main deficiencies” were related to sterility assurance and risk of contamination/defects of the final product. The critical deficiencies included: ● failure to fully investigate and document out-of-specification results for microbiological environmental monitoring in class A isolator and class B/C surrounding areas ● use of an expired reagent in manufacturing, and ● incomplete master batch records with inadequate QA review.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
