Des données incomplètes et un processus de gestion des retests incorrect...

On peut résumer ainsi les remarques présentes dans l'injonction de l'US FDA à cette société japonaise :

1.    Your firm failed to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)(4)).

 

Reliance on incomplete data

Our investigator reviewed the audit trails generated by your high performance liquid chromatography (HPLC) system for impurities testing that you conducted on (b)(4) (lots (b)(4), (b)(4), (b)(4)). The audit trail showed that you performed this testing in duplicate. The audit trail indicated that you conducted a chromatography sequence analyzing impurities on samples of these lots beginning at (b)(4) on April14, 2014. The audit trail showed that a new sequence was started approximately 24 hours later, at (b)(4) on April 15, 2014, for impurities testing that again included samples for lots (b)(4), (b)(4), and (b)(4). None of the 19 chromatograms generated in the first sequence were maintained and available for review. Only the second set of chromatograms was maintained and relied upon in releasing lots (b)(4), (b)(4), and (b)(4) for use in the manufacture of products for the U.S. market. You could not provide any rationale for not maintaining the original data, and you failed to document a scientific justification for repeating the analysis.

 

Failure to appropriately maintain data

You do not maintain electronic data on your ultraviolet-visible spectrophotometer UV SP-502 which you use for content uniformity and identity testing of (b)(4) capsules, and it does not have an audit trail...

 

2.    Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

 

Your analysts told our investigator that, until June 1, 2016, they were permitted to perform repeat testing without scientific justification or documentation. They also told our investigator that they were not required to maintain the data from the original results when performing investigations of system suitability failures, suspected errors, or out-of-trend results. Our investigator reviewed records of your investigations for a two-year period and found that you recorded only two minor deviations in the production area and no out-of-specification investigations...

 

Plus d'information sur cette injonction ici.

Plus d'information sur la gestion des OOS et la documentation des investigations ici et là.