LEXICON
No.83 September 26, 2011

GMP (Good Manufacturing Practice) (compliance) inspections
GMP(適合性)調査
GMP inspectors
GMP調査員
Sampling (samples); collection of samples
収去(品)

GMP (Good Manufacturing Practice) (compliance) inspections (GMP(適合性)調査) are conducted by GMP inspectors (GMP調査員) from the Pharmaceuticals and Medical Devices Agency (PMDA; 医薬品医療機器総合機構) or prefectural governments (都道府県). Domestic manufacturing facilities for new drugs (新医薬品), biopharmaceuticals (生物学的製剤), radiopharmaceuticals (放射性医薬品), products subject to...

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