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

L'agence américaine pointe du doigt une fois encore des 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 captured the date of the change and who made the change.

Other significant deficiencies noted in your laboratory system include:

a)    Failure to have a written procedure for manual integration despite its prevalence.
b)    Failure to use separate passwords for each analyst’s access to the laboratory systems.
c)    Use of uncontrolled worksheets for raw analytical data in your laboratory.
d)    Presence of many uncontrolled chromatograms, spreadsheets and notes of unknown origin found in a drawer.

4.    Your firm did not record all CGMP activities at the time these were performed. The lack of contemporaneous documentation of CGMP activities increases the likelihood of recording erroneous data (21 CFR 211.188).

In addition, our inspection documented multiple instances where the analysts did not record raw material lot numbers during sample preparation, making it impossible to link the raw materials used to the appropriate test worksheet. This raises concerns about the authenticity of the data that your laboratory testing generates. 

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