ベンズアルデヒドを試薬としてMFに規格を記載すること等について、御社のご希望通りの内容でMFを変更することになりました。ただ、「軽微変更届」の届け出が必要なので、添付の書類にBさんのサインを頂き、返送いただけますか？
①原薬等登録原簿軽微変更届書
「軽微変更届」の表紙です。具体的な変更内容は、先日お送りした「MF変更」になります。
➁宣誓書
下記の内容が書かれています。
「このたび提出いたしました軽微変更届出に記載した変更は，適切なバリデーション，変更管理を実施したことを宣誓します。」
Rating
52
Translation / English
- Posted at 28 Jan 2020 at 15:56
Regarding to add specification of benzaldehyde on MF as a reagent, we decided to revise MF as you requested. We need to submit "Notification of Minor Changes", so could you make B's signature on the following document and sign back to us?
1. Notification of Minor Changes of Registered Ledger on Drug Substance, etc.
This is a cover of Notification of Minor Changes. The details of the change is "MF Change" as we sent for you the earlier.
2. Written Oath
The following contents are written on this doc.
"We swear that the change written in Notification of Minor Changes we submitted this time already had appropriate validation and management of this change"
1. Notification of Minor Changes of Registered Ledger on Drug Substance, etc.
This is a cover of Notification of Minor Changes. The details of the change is "MF Change" as we sent for you the earlier.
2. Written Oath
The following contents are written on this doc.
"We swear that the change written in Notification of Minor Changes we submitted this time already had appropriate validation and management of this change"
Rating
50
Translation / English
- Posted at 28 Jan 2020 at 15:56
Following your request, pertaining to matters such as describing the standards of benzaldehyde on MF as a reagent, we have come to modify the MF as follows. However the submission of “Notification of minor changes” is required, would you please have B sign on the attached document and return it to me?
1. Notification of minor changes to drug substance registration registry
It is the cover page of "Notification of minor changes". Please refer to the "MF modification" which was sent to you the other day for the specific content of the change.
2. Oath
It descrives the following details:
"I swear that the changes described in the minor change notification submitted this time have been properly validated and managed."
1. Notification of minor changes to drug substance registration registry
It is the cover page of "Notification of minor changes". Please refer to the "MF modification" which was sent to you the other day for the specific content of the change.
2. Oath
It descrives the following details:
"I swear that the changes described in the minor change notification submitted this time have been properly validated and managed."
Rating
50
Translation / English
- Posted at 28 Jan 2020 at 16:09
We have decided to amend MF mentioning benzaldehyde as a test reagent on the specification of MF in accordance with your request. However, as it is required to submit "minor amendment report, could you please have attached document signed by Mr. B and send back to us?
(1) Minor amendment report for the drug master file
This is the cover page for "Minor amendment report. Contents of the amendment is as per "MF amendment" we have already sent to you some days ago.
(2)Testimony
Following information is written;
"We herewith testify that the amendment written in this minor amendment report is performed under appropriate validation and administration of the amendment."
Best regards,
(1) Minor amendment report for the drug master file
This is the cover page for "Minor amendment report. Contents of the amendment is as per "MF amendment" we have already sent to you some days ago.
(2)Testimony
Following information is written;
"We herewith testify that the amendment written in this minor amendment report is performed under appropriate validation and administration of the amendment."
Best regards,
