日本の薬事法の関係で、資料AとBを修正しました。
下記のアップデート版を添付にて送るので差替えて下さい。そして、添付資料Cを印刷して保管して下さい。
4.4条の「確認事項」に"Lot No"を追加した。
別紙1に"Lot No"を記入する欄を追加しました。
全ての書類に"Lot No"を記入する欄を追加しました。"Production No"と同じで構わないので、"Lot No."を記入して下さい。
資料Dの表にある"Lot No"には原材料の"Lot No"を記入して下さい。
評価
66
翻訳 / 英語
- 2013/11/22 17:12:24に投稿されました
I have corrected documents A and B due to Japanese Pharmaceutical Affairs Law.
Please replace it with the following updated version that I will attach here.
Please also print out the attached document C and preserve it.
I have added "Lot No" to "Confirmation Points" of Article 4.4.
I have also added a space on a separate sheet of paper to add "Lot No."
All the documents now have a space to include "Lot No."
Please fill in the details of "Lot No" as with "Production No."
Please fill in the "Lot No" of the original ingredients on the list of document D.
Please replace it with the following updated version that I will attach here.
Please also print out the attached document C and preserve it.
I have added "Lot No" to "Confirmation Points" of Article 4.4.
I have also added a space on a separate sheet of paper to add "Lot No."
All the documents now have a space to include "Lot No."
Please fill in the details of "Lot No" as with "Production No."
Please fill in the "Lot No" of the original ingredients on the list of document D.
評価
60
翻訳 / 英語
- 2013/11/22 17:09:00に投稿されました
In relation to the Japan Pharmaceutical Affairs Law, I have fixed materials A and B.
Please replace it with the following updated version attachment. Please also print and keep a copy of attachment C.
I have added "Lot No" in the "confirmation section" of article 4.4.
I have added an input column for the "Lot No" in a separate sheet.
I have added an input column for the "Lot No" in all the documents. It does not matter if it is the same with the "Production No" so please input the "Lot No.".
Please input the "Lot No" of the raw materials to the "Lot No" section in the table of material D.
Please replace it with the following updated version attachment. Please also print and keep a copy of attachment C.
I have added "Lot No" in the "confirmation section" of article 4.4.
I have added an input column for the "Lot No" in a separate sheet.
I have added an input column for the "Lot No" in all the documents. It does not matter if it is the same with the "Production No" so please input the "Lot No.".
Please input the "Lot No" of the raw materials to the "Lot No" section in the table of material D.
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