Cette société indienne a reçue une mise en demeure sévère sur plusieurs points liés à la "data integrity" :
1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
Your laboratory records did not contain all raw data generated during each test for finished drug products manufactured at your firm. Your quality unit relied on incomplete records to make batch release decisions in support of regulatory submissions to the Agency.
During the inspection, your management acknowledged that employees in your QC laboratories conduct trial HPLC injections prior to the injections submitted as the reported test results. These trial injection data files were stored on separate drives from the reported test result data. In some cases original data files were deleted. The results from these trial injections and other original data were not reported...
2. 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)).
During the inspection, our investigator reviewed data from your high performance liquid chromatography (HPLC) analysis for release testing, including assay and impurity testing. Your quality control analysts used administrator privileges to change the controls for the time and date settings and manipulate file names to overwrite injections and delete original HPLC test data. Analysts also routinely turned HPLC audit trails on and off. Your response acknowledges these practices.
3. Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to document same at the time of performance (21 CFR 211.100(b)).
Our investigator discovered that your firm was destroying original batch records and backdating revised replacement pages. For example, our investigator found original pages from five (b)(4) batch records (batches (b)(4) to (b)(4)) discarded outside your facility. Your quality control unit approved revised and backdated master batch record pages that your firm created to replace the discarded pages. The original data were subsequently transcribed and backdated to the time of production. Quality and production managers allowed this practice.
Plus d'information sur cette "warning letter" ici.
Pour en savoir plus sur la "Data integrity" : la position des autorités réglementaires (MHRA, FDA, OMS), les actions de maîtrise du risque mises en oeuvre par des industriels (LILLY, UCB), nous vous invitons à vous inscrire à la journée A3P SUISSE sur "eCompliance - Data Integrity" le 12 mai prochain à Lausanne.