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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...

En 2013, cette société avait déjà fait l'objet d'une injonction des autorités américaines pour des sujets similaires ; cette nouvelle injonction insiste sur la gestion des OOS, la revue des résultats, l'absence de validation de certains équipements et des défaillances dans l'enregistrement de données cGMP : 3.   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)).   While reviewing gas chromatography data on instrument QA/G07, our investigator found unreported results, including an out-of-specification (OOS) test result for raw materials. You did not investigate this OOS result or explain why you excluded the failing result from the official record.   Our investigator also found that you reported only two of three chromatographic injections of sterile (b)(4) batch (b)(4) during in-process (b)(4) sample testing for residual ...

Développée en janvier 2016 par les Laboratoires Officiels de Contrôle des Médicaments (OMCL), la Directive sur la Gestion des Documents et des Enregistrements traite de la gestion des documents, enregistrements et données internes et externes relatifs aux activités des OMCL. Cette directive, pertinente pour les laboratoires, peut être utilisée pour établir les contrôles associés à l'intégrité des données. Cette directive peut être consultée ici .

Dans le cas de ce fabricant d'API chinois, le traitement des résultats en dehors des critères d'acceptation constitue un écart majeur : 1.      Failure to adequately investigate and document out-of-specification results according to a procedure, and implement appropriate corrective actions.   Our investigator found that your firm repeatedly, and without justification, resampled and retested crude heparin batches when your quantitative polymerase chain reaction (Q-PCR) test for ruminant DNA exceeded your established specification limit of ≤  (b)(4)  parts per million (ppm). As a result, your firm used crude heparin batches that potentially were out-of-specification (OOS) to manufacture heparin sodium API for the U.S. market.   For example, according to your Deviation Handling Sheet No.07-2015021, you resampled and tested crude heparin batch Y102-1504005 multiple times, with the following results.   Ruminant DNA Q-PCR test re...

Dans le cadre de son développement, ce groupe international français recherche u n(e) responsable Assurance Qualité Informatique et un(e) chef de projet Validation Informatique ERP. Basé dans le sud-ouest de la France, ces deux postes sont à pourvoir rapidement. Si vous souhaitez des plus amples informations, contactez-nous ici .

Cette injonction contient de nombreuses violations des principes de "data integrity" : 1.    Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established API specifications and standards. Our investigator found that you failed to maintain complete data from all laboratory analyses, and that you relied on the incomplete information to determine whether your drugs met established specifications. For example: a.     Numerous data files were found in the recycle bin folder on the computer connected to gas chromatography instruments GC-4 and GC-6. Specifically, our investigator found deleted data for residual solvent testing for (b)(4) lot (b)(4) in the recycle bin. Your records show that you retested the lot without documented justification or an investigation. You retained only the final test result. b.    During the inspection our investigator requested residual solvent release test data for two of...

2.    Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.   Our investigators observed systemic data manipulation across your facility. They documented unexplained deletions of laboratory test results . They discovered that you repeated tests until you obtained acceptable results and that you failed to investigate out-of-specification or otherwise undesirable test result s. Your firm relied on these falsified and manipulated test results to support batch release and stability data. Your firm routinely re-tested high performance liquid chromatography (HPLC) samples and deleted previous chromatograms without justification. Your management acknowledged that employees in your quality control laboratory have access, authority, and the ability to delete and repeat HPLC injections when undesirable results were encountered prior to reporting final results... Reducing the number of ...