Translator Reviews ( Japanese → English )
Rating: 53 / Native Japanese / 0 Reviews / 28 Jan 2020 at 18:19
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. As for methanol & water cleaning in Step 1, the number of times has been increased from 4 to 5.
Can you please tell me the reason?
2. Chlorid is deleted from IPC2. Does it mean that it wasn't carried out? If so, can you please tell me the reason?
Comparing the new one and the old one, I have made a comparison table.
Please check it and let me know if there are any corrections or changes made besides the above 2 points.
Also, since the manufacturing record has been changed, MF needs to be changed as well.
In that case, a brief talk with PMDA will also be necessary.