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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)...

L'agence américaine mentionne l'incapacité de cette société indienne à fournir des enregistrements électroniques à des fins d'inspection : 3.        Failure to provide records required to be readily available for authorized inspection (21 CFR 211.180(c)).   During the inspection on October 18, 2016, your firm did not provide batch records to our investigator. At the conclusion of the inspection, you stated that you would provide these records electronically within a matter of days. To date, FDA has not received any batch records. Plus d'information ici . Ne manquez pas l'événement A3P du GIC eCompliance sur la Data Integrity le 20 juin prochain à Lyon ; plus d'information ici .  

Les certificats d'analyses stipulaient que tous les contenants de matière première active étaient identifiés alors que ce n'était pas le cas. Plus d'information ici .

Pour ce fabricant d'API chinois, les certificats d'analyse émis sont incomplets : 1.        Failure to transfer all quality or regulatory information received from the API manufacturer to your customers.   You omitted the name and address of the original API manufacturers on the certificates of analysis (COA) you issued to your customers, and did not include copies of the original batch certificate.   For multiple API, you generated COA by copying and pasting analytical results from the original API manufacturers, replacing the manufacturers’ information with your letterhead, then issuing these COA to your customers. You omitted critical information, including the original manufacturers’ names and addresses and the names, addresses, and telephone numbers of laboratories that performed the testing.   Customers and regulators rely on COA for information about the quality and sourcing of drugs and their components. Omitting in...

Cette mise en demeure met l'accent sur la copie des enregistrements à destination des inspecteurs : 3.        Limiting access to or copying of records   Your firm limited access to or copying of records that our investigators were entitled to inspect . For example, our investigators requested records of your audit trail data from all chromatographic systems used to test drugs for the U.S. market at your facility. The files you ultimately provided (in the form of Excel spreadsheets rather than direct exports from your chromatographic software) were not the original records or true copies, and showed signs of manipulatio n. The records you did provide contained highlighting, used inconsistent date formats, and lacked timestamp data; these features are inconsistent with original data directly exported from chromatographic testing software.   Our investigators and their supervisor explained at least twice that the data you provided was ...