Encore un rappel à l'ordre de l'US FDA...
Dans la gestion des données :
2. Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
Your firm failed to prevent raw data from being deleted from the Atomic Absorption Spectrophotometer (AAS) used for elemental analysis testing. Specifically, our investigation found laboratory analysts had access to delete and overwrite AAS raw data. This instrument did not have sufficient controls to prevent unauthorized access to, changes to, or omission of data files and folders. This is especially concerning because our inspection uncovered only 38 raw data files on the hard drive of the AAS, while analysts stated that the AAS had been used for over 400 analyses. Your firm failed to store the raw data elsewhere. Therefore, all AAS testing results for which no raw data exists are in doubt. Your firm’s improper control over the laboratory records raises concerns about the quality of the APIs your firm has released.
Et dans la gestion des "Batch records" :
4. Failure to ensure that APIs are produced according to pre-approved instructions and that batch production records include complete information pertaining to the production of each batch.
For example:
- Your firm erroneously calculated and then used the incorrect amounts of starting materials on multiple occasions. The inspection found that your firm did not calculate correct proportions of starting materials that were released for the production of (b)(4) USP and (b)(4) USP. Your firm’s Master Formula Records (MFRs) specify the proportions of raw materials, but your Batch Production Records (BPRs) do not include or describe calculations to appropriately adjust the amounts of starting materials to be used for a given batch size.
- Your firm released APIs using BPRs that did not include the signatures of the production operators that performed each significant step or operation.
- Your firm released API where production records contained missing information. For example, our inspection uncovered a Cleaning Report where the rinse sample pH was entered as “nil” despite the pH being a requirement to ensure the equipment is clean.
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