Translator Reviews ( Japanese → English )
Rating: 50 / 0 Reviews / 28 Jan 2020 at 18:12
①Step1のメタノール、水の洗浄が4回から5回に増えていますが、理由を教えて頂けますか。
➁IPC2のChloridが削除されていますが、実施していないでしょうか?実施していないのであれば、理由を教えて頂けますか。
新旧版を照合して、対照表を作成しましたので、ご確認いただき、上記の2点以外にも、修正と変更があれば、お知らせください。
また、製造記録書が変更になっている為、MFの変更も必要になりますが、その場合、PMDAとの簡易相談が必要になります。
1. Cleaning of methanol and water has been increased from four to five time in step 1. Would you let me know its reason?
2. Chlorid of IPPC2 has been deleted. I wonder if it has not been carried out? If you have not carried it out, would you let me know the reason?
As I made a list of matching for matching the new and old version, please let me know if you find a correction and change other than the two points above.
In addition, as record of manufacturing has been changed, we have to change MF, too. In that case, we need to consult with PMDAj briefly.