LEXICON
No.83
September 26, 2011
GMP (Good Manufacturing Practice) (compliance) inspectionsGMP(適合性)調査GMP inspectorsGMP調査員Sampling (samples); collection of samples収去(品)
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...
To read the full story
LEXICON
-
Elective Care Scheme for LLPs長期収載品 選定療養制度July 19, 2024
-
G1/G2 RuleG1/G2ルールMarch 9, 2018
-
New PMP Criteria新薬創出加算の新要件March 9, 2018
-
Cost-Based Method原価計算方式July 27, 2017
-
Sakigake Designation Scheme先駆け審査指定制度August 17, 2016
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…




