Warning letter #320-13-24(2) 消毒剤の使用
1. Your firm failed to establish adequate systems for monitoring environmental conditions and for cleaning and di ...
Warning letter #320-13-24(1) 211.42(C) 環境モニタリング
2013/08/20 ホームページ掲載
web site
WL#:320-13-24
Date:August 9, 201 ...
Warning letter #320-13-23(3) データの完全性
3. Failure to follow and document quality-related activities at the time they are performed.
指摘内容:①査察中に、QC試験担当者 ...
Warning letter #320-13-23(2) 試験法のバリデーション
2. Failure to ensure that test procedures are scientifically sound and appropriate to ensure that key starting mater ...
Warning letter #320-13-23 コンピュータデータのアクセス制限
■2013/08/20 ホームページ掲載
web site
WL#:320-13-23
Date:August 02, 2 ...
Warning letter #320-13-21(9) 211.25(a) 教育訓練
5. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug ...
Warning letter #320-13-21(8) 211.160(a) 監査証跡
4. Your firm failed to record and justify any deviations from required laboratory control mechanisms (21 CFR 211.160( ...
Warning letter #320-13-21(7) 211.194(a) データのインテグリティ
3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ass ...
Warning letter #320-13-21(6)211.188(b) バッチ記録
2. Your firm failed to prepare batch production and control records for each batch of drug product that include docum ...
Warning letter #320-13-21(5) 査察妨害行為(delay)
妨害行為 e. 2013/3/20に、査察官は●錠剤のバッチ番号●~●の試験記録(QCデータ一式と生データ)をリクエストした。この日、査察官は少なくとも6回同じリクエストをした。そして、翌日にも複数回リクエストした。そのデータは、翌々 ...