Ce laboratoire allemand qui dispose de deux sites en Inde a été mis en demeure par l'agence américaine notamment sur les écarts suivants :
1. Your firm failed to prepare batch production and control records for each batch of drug product that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch (21 CFR 211.188(b)).On August 28, 2014, FDA investigators identified instances of non-contemporaneous documentation of batch production activities. Two uncontrolled Excel spreadsheets were used to record discrepancies and certain in-process drug quality data. This data was initially missing in the batch manufacturing record. Your firm later entered this data into batch records and backdated them.
2. Your firm failed to maintain adequate written records of major equipment maintenance (21 CFR 211.182).On August 25, 2014, FDA investigators found original preventive maintenance work orders in trash bags. A partially-completed document retrieved from the waste receptacle included handwritten notes about the condition of equipment observed during preventive maintenance. However, the corresponding official record did not include the same information. Your response did not sufficiently identify the scope of these practices at your facility.
3. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions, and that training in current good manufacturing practice is conducted by qualified individuals (21 CFR 211.25(a)).
During interviews with our investigators, your contract employee who trains other contract employees on good documentation practices was unable to explain the material he was required to present during training. In addition, while a significant number of your contract employees do not speak English, you only provided English training materials to these employees.We also found an employee’s failing equipment qualification training assessment form in the trash, yet that employee’s official file showed passing results. According to your company policies, personnel with failing scores must be retrained, but your firm was unable to provide evidence of retraining in the employee’s official record.
5. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).
On August 25, 2014, we found there were no access restrictions to laboratory data generated by the (b)(4) instrument used to test and release raw materials and in-process drug products. Your laboratory computer systems lack necessary controls to prevent data tampering and to detect data that may have been compromised.
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