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FDAのGMP査察から学ぶ : 読めばわかる査察官の視点・指摘の意図 第2版

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FDAのGMP査察から学ぶ : 読めばわかる査察官の視点・指摘の意図

第2版

Call No. (NDL)
DL533-M122
Bibliographic ID of National Diet Library
030635230
Material type
図書
Author
佐々木次雄 編
Publisher
じほう
Publication date
2020.9
Material Format
Paper
Capacity, size, etc.
14, 592p ; 26cm
NDC
499.5
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Detailed bibliographic record

Summary, etc.:

●GMPをリードするFDAの規制や査察での指摘事項を解説!(Provided by: 出版情報登録センター(JPRO))

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Table of Contents

  • 目次

  • 「第1章」 GMP査察とFDAの組織/ 1

  • 1.1 GMP査察は相互承認協定(MRA)時代に/ 2

  • 「1」 EUと米国間のMRA締結/ 3

  • 「2」 日本とEUとのMRA/MOU/ 6

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Paper

Material Type
図書
ISBN
978-4-8407-5310-4
Title Transcription
エフディーエー ノ ジーエムピー ササツ カラ マナブ : ヨメバ ワカル ササツカン ノ シテン シテキ ノ イト
Author/Editor
佐々木次雄 編
Edition
第2版
Author Heading
佐々木, 次雄 ササキ, ツグオ ( 00519153 )Authorities
Publication, Distribution, etc.
Publication Date
2020.9
Publication Date (W3CDTF)
2020