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KMID : 1142220090040010013
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Regulatory Research on Food, Drug & Cosmetic
2009 Volume.4 No. 1 p.13 ~ p.19
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Guideline on the Requirements for a Plasma Master File
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Kang Hye-Na
Oh Young-Hoon
Oh Ho-Jung
Kim Pan-Soon
Kim Soon-Nam
Lee Nae-Ry
Kim Jeoung-Gen
Park Hee-Young
Jung Jae-Ho
Kim Joo-Il
Hong Seung-Hwa
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Abstract
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Plasma Master File (PMF) is documentation which includes detail information about collection and control of source plasma to assure the safety of the plasma. The information covers all aspects of the use of plasma from collection to plasma pool. PMF also includes a system in place which enables the path taken by each donation to be traced from the blood/plasma collection establishment through to finished products and vice versa. PMF is important in the view of GMP, which is intended to assure the safety of medicinal products from the starting material to finished products, as a document like Drug Master File. EU has the concept of PMFcertification as an optional procedure since 1994, so Korea Food and Drug Administration is going to publish a guideline based on the EU guideline "Guideline on the Scientific Data Requirements for a Plasma Master File (PMF)" before the PMF system might be used to assure the safety and quality of source plasma and also applied to product licence system for plasma-derived products.
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KEYWORD
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Plasma master file, Plasma-derived Products
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FullTexts / Linksout information
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