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
![[deleted user]](https://secure.gravatar.com/avatar/695023b4efd563721d13716b1457bc73.png?d=identicon&mode=crop&r=PG&s=42)
Rating
52
Translation / English
- Posted at 11 Oct 2019 at 08:02
A has said that it would like to apply the inspection of compliance within this month.
Therefore, please submit the format 1 and format 2 by 21st.
We have received a document of 2 for the inspection, and 3 for the certificate for the conformance, but are these the most update one, right? Otherwise, please send us the latest one.
1. 3 lot of CoA, created by the process validation under the use of PKZ at the new supplier.
2. 3 lot of CoA at ketoconazole, created soon to be used with PKZ at the new supplier.
Therefore, please submit the format 1 and format 2 by 21st.
We have received a document of 2 for the inspection, and 3 for the certificate for the conformance, but are these the most update one, right? Otherwise, please send us the latest one.
1. 3 lot of CoA, created by the process validation under the use of PKZ at the new supplier.
2. 3 lot of CoA at ketoconazole, created soon to be used with PKZ at the new supplier.
Rating
50
Translation / English
- Posted at 11 Oct 2019 at 08:07
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.
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.
Rating
50
Translation / English
- Posted at 11 Oct 2019 at 08:21
Got an inquiry from A company that he want to apply for a suitability research within this month.
Therefore hope you to submit us till 21th after fill the form 1 and 2 out. Although we received the document② about an inspection and the document③ about a certification of suitability research, are theses newest ones? If not, please send us the newest ones. ①CoA of 3 lots was made by the process variation using PKZ from new supplier. ②CoA of 3 Ketoconazole lots was currently manufactured by PKZ from conventional supplier.
Therefore hope you to submit us till 21th after fill the form 1 and 2 out. Although we received the document② about an inspection and the document③ about a certification of suitability research, are theses newest ones? If not, please send us the newest ones. ①CoA of 3 lots was made by the process variation using PKZ from new supplier. ②CoA of 3 Ketoconazole lots was currently manufactured by PKZ from conventional supplier.
Rating
50
Translation / English
- Posted at 11 Oct 2019 at 08:11
I have gotten a message from A company, which says that A company would like to apply for suitability survey within this month.
So please fill in the document1,2 and submit them.
As to Inspection, I already got from you before, but please advise me if it is the newest one.
If not, please send the newest one over to us.
1.CoA of 3 Lot which is made by the method of PKZ for the new supply destination.
2CoA of 3 Lot Ketoconazole which has been made recently by the method of PKZ for the conventional supply destination.
So please fill in the document1,2 and submit them.
As to Inspection, I already got from you before, but please advise me if it is the newest one.
If not, please send the newest one over to us.
1.CoA of 3 Lot which is made by the method of PKZ for the new supply destination.
2CoA of 3 Lot Ketoconazole which has been made recently by the method of PKZ for the conventional supply destination.
