Articles

Affichage des articles du janvier, 2015

Des problèmes d'intégrité de données pour ce fabricant d'API

L'agence américaine pointe du doigt une fois encoredes insuffisances dans la maîtrise des données de laboratoire d'un fabricant d'API.
1.    Failure to manage laboratory systems with sufficient controls to ensure conformance to established specifications and prevent omission of data.
Our inspection revealed serious deficiencies related to your documentation practices, including missing raw data. It is a basic responsibility of your quality unit to ensure that your firm retains the supporting raw data that demonstrates your APIs meet specifications that they are purported to possess...

In addition, the inspection documented that your firm made changes to integration parameters for the impurities test without appropriate documentation or justification. Your firm relied upon hand written notes on a chromatogram discovered in a drawer at the laboratory as the documentation for this change. Furthermore, your firm implemented this change without an audit trail that would have capt…