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 face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…




