Transcription of 別紙（3） PIC/S GMPガイドライン アネックス2
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別紙（3） PIC/S GMPガイドライン アネックス2
PIC/S GMP .. MANUFACTURE OF BIOLOGICAL medicinal ( ) . SUBSTANCES AND PRODUCTS FOR HUMAN USE. SCOPE . The methods employed in the manufacture of biological . medicinal substances and products are a critical factor in . shaping the appropriate regulatory control. Biological . medicinal substances and products can be defined . therefore largely by reference to their method of . manufacture. This annex provides guidance on the full . range of medicinal substances and products defined as biological. This annex is divided into two main parts: 2 . a) Part A contains supplementary guidance on the a) A . manufacture of biological medicinal substances and . products, from control over seed lots and cell banks or . starting material through to finishing activities and testing.. b) Part B contains further guidance on selected types of b) B.
別紙（3） pic/s gmpガイドライン アネックス2 原文 和訳 manufacture of biological medicinal substances and products for human use
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