Translator Reviews ( Japanese → English )

Japanese

A社から適合性調査の申請を今月中にしたいとの連絡を頂きました。つきましては、様式1と様式2を記入の上、21日まで提出をお願いします。Inspectionについては②の資料、GMP適合性証明書については③を、以前いただきましたが、こちらは最新版でしょうか？最新版でなければ、最新版を送ってください。
①新しい供給先のPKZを使用して行ったプロセスバリデーションでできた３ロットのCoA
②従来の供給先のPKZを使用して直近に製造したケトコナゾール3ロットのCoA

English

I received a message from A that they want to apply research of applicability within this month. Would you submit it until 21st after filling out style 1 and style 2? We received document of 2 for inspection and 3 for GMP certificate of applicability before. Are they the newest? If they are not the newest ones, please send the newest one.

1. CoA of 3 lots that was made by process validation conducted by using PKZ of the new company to which provided.
2. CoA of 3 lots ketoconazole made immediately before by using PKZ of the conventional company to which provided.