Des manquements importants pour ce fabricant chinois

Ce fabricant chinois a reçu une injonction sévère des autorités américaines dont certaines sont liées à l'intégrité des données :

3.    Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.

For example, our investigator reviewed the audit trail from your assay testing for (b)(4) lot (b)(4), and found that you tested the same sample set three times over several days without documentation or investigation. You reported only the result of the third and final test for purposes of completing your certificate of analysis and releasing this batch of API.

4.    Failure to prepare adequate batch production records and record the activities at the time they are performed.

For example, our investigator found that your operator used process parameter values from previous batches of (b)(4) to complete new batch records when she was too tired to immediately record the data and had forgotten the values.          

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