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[null,"別紙３－１"]
[]
[null,null,"製造工程の区分："]
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[null,"管理番号","品目名","剤形 ","製造工程 ","製造工程\nの特性","承認番号 ","製造販売\n業者名","原薬情報","高生理活性物質等との設備の共用に関する情報",null,null,null,"過去３年間の実績",null,null,null,null,null,"GQP省令第７条に基づく取決め日","備考"]
[null,null,null,null,null,null,null,null,null,"建物・製造区域の\n共用の有無","左記で共用「有」の場合、共用する物質の種類","製造設備機器の\n共用の有無","左記で共用「有」の場合、共用する物質の種類","査察","逸脱件数","OOS件数","品質情報件数","変更件数","製造　　　ロット数"]
[]
[null,null,null,null,null,null,null,null,null,"（有の場合）\n〇\n記載","高生理活性物質\nペニシリン系抗生物質\nβラクタム系抗生物質\n該当なし\nを記載する。","（有の場合）\n〇\n記載","高生理活性物質\nペニシリン系抗生物質\nβラクタム系抗生物質\nGMP省令適用外物質\n該当なし\nを記載する。","（有の場合）\n〇\n記載"]