3)異物(炭酸カルシウム)の混入が原料由来と特定できた時、過去に遡り混入していない事の証明ができ
ますか？
→もし証明できない場合は、A社の方針では、自主回収となります。
例）ラニチジン自主回収（添付資料④）
現時点での検出されいない発がん性物質の混入を完全に否定できないため
以上の課題が解決できるか、またそれがいつまでに回答できるかを教えて下さい。
評価
52
翻訳 / 英語
- 2019/11/29 07:30:57に投稿されました
3) When the contamination(calcium carbonate) is to be confirmed for the origin of material used, will you be able to prove not to be contaminated on the production for the past ?
→Unless it can be confirmed , a voluntary recall has to be perfumed by the decision of A company .
eg) Voluntary recall on ranitidine(see the attached document 4)
Carcinogen which isn't detected yet cannot be dined completely at the moment.
Please tell us the possibility of solving issues above and until when to be finished to perform?
→Unless it can be confirmed , a voluntary recall has to be perfumed by the decision of A company .
eg) Voluntary recall on ranitidine(see the attached document 4)
Carcinogen which isn't detected yet cannot be dined completely at the moment.
Please tell us the possibility of solving issues above and until when to be finished to perform?
評価
53
翻訳 / 英語
- 2019/11/29 07:48:51に投稿されました
3) When you identify that the contamination of the foreign material (calcium carbonate) was mixed in the raw material, are you able to prove that there was no contamination in the past?
→ If this cannot be proved, it will be recalled based on Company A's policy.
Example) Recall of Ranitidine (Attachment ④)
Since at the moment it cannot be completely denied that there is no contamination of carcinogenic substances that have not been detected, please kindly let us know whether these issues can be resolved, and when will you be able to answer these questions?
→ If this cannot be proved, it will be recalled based on Company A's policy.
Example) Recall of Ranitidine (Attachment ④)
Since at the moment it cannot be completely denied that there is no contamination of carcinogenic substances that have not been detected, please kindly let us know whether these issues can be resolved, and when will you be able to answer these questions?
