Glossary
Master Standard Documents (Gijunseo)
The collective name for the four basic documents a Korean manufacturer must hold in order to carry out manufacturing and quality control properly.
Source · 「의약품 등의 안전에 관한 규칙」 [별표 1] 의약품 제조 및 품질관리기준, 제4호 기준서(제4.1호 제품표준서~제4.4호 제조위생관리기준서) Korean original
Details
Korean GMP requires the documents to be held by name, as four: the product standard document, the quality control standard document, the manufacturing control standard document, and the manufacturing hygiene control standard document. A product standard document is prepared for each product and must be approved by signature of both the head of the manufacturing department and the head of the quality (assurance) department before it is used. MFDS inspection findings usually take the form of failure to comply with the standard documents, citing the fact that the company did not follow the document control and change control rules it had written into its own standard documents. Examples are records required to be made at the time of the work but not made that way, and a test method changed without a change request being raised.
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Source
「의약품 등의 안전에 관한 규칙」 [별표 1] 의약품 제조 및 품질관리기준, 제4호 기준서(제4.1호 제품표준서~제4.4호 제조위생관리기준서) Korean originalGRM Regulatory Glossary
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