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。
Rating
53
Translation / English
- Posted at 28 Jan 2020 at 18:19
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.
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.
Rating
50
Translation / English
- Posted at 28 Jan 2020 at 18:11
① Although in the step 1's ethanol washing , water washing from 4 times to 5 times are increasing, please tell us the reason.
② Although IPC2's Chlorid was taken off, is it not going to be carried out? If not, please tell us the reason.
By comparing the old and new, as we make a comparison table, please check it, and except the above 2 matters, if there is correction, please let us know.
Also, as the production record form has been corrected, MF's change needs, but in this case it needs a brief consultant with PMDA.
② Although IPC2's Chlorid was taken off, is it not going to be carried out? If not, please tell us the reason.
By comparing the old and new, as we make a comparison table, please check it, and except the above 2 matters, if there is correction, please let us know.
Also, as the production record form has been corrected, MF's change needs, but in this case it needs a brief consultant with PMDA.
Rating
50
Translation / English
- Posted at 28 Jan 2020 at 18:12
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.
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.
Rating
52
Translation / English
- Posted at 28 Jan 2020 at 18:16
1. Could you tell me the reason because washing with ethanol and water has been increased from 4 times to 5 times, please?
2. As chloride of IPC2 has been removed, didn't you do this procedure? Please tell me the reason.
Referred to new and old version, I have created a comparison table so that please check it, and if you find any other for amendment or revision to be needed other than those 2 points, please let me know additionally.
In addition, as production record has been revised, the change MF will be required. In this case, it will be required for a simple consultation with PMDA.
2. As chloride of IPC2 has been removed, didn't you do this procedure? Please tell me the reason.
Referred to new and old version, I have created a comparison table so that please check it, and if you find any other for amendment or revision to be needed other than those 2 points, please let me know additionally.
In addition, as production record has been revised, the change MF will be required. In this case, it will be required for a simple consultation with PMDA.
