Translator Reviews ( Japanese → English )

Japanese

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。」

English

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,