COETIC votre partenaire pour la gestion et la validation de vos projets réglementés GxP

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 ...

Pour ce fournisseur d'API tchèque : 1.    Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data. Your quality control unit did not have basic controls to prevent changes to your electronically-stored laboratory data. Your analysts had user privileges to the Empower-2 system used to generate and analyze chromatographic data that allowed them to eliminate failing, atypical and satisfactory results with no notification; alter peak areas; and add or eliminate samples from sequences without authorization... Your quality unit must review all pertinent analytical data when making batch release decisions. However, your automated system permitted analysts to delete and alter test results without authorization. As a result, your quality unit was presented with incomplete and inaccurate information about the quality of your drugs. According to your response, you restricted access and permissions in th...

Salesforce, à l'occasion de l'étape parisienne de son World Tour, a ouvert son datacenter français en juin dernier. En fin de semaine dernière, c'est AWS, le leader mondial du Cloud d'infrastructure, qui a annoncé la localisation des données sur le territoire en 2017. Dans un communiqué, Microsoft "annonce son intention d’élargir la variété des options Cloud offertes à ses clients en Europe et dans le monde en proposant Microsoft Azure, Office 365, et Dynamics 365 depuis plusieurs datacenters en France." Pour les administrations françaises, localiser les données en France est une obligation.  En outre, différents secteurs comme la banque et l'assurance ont engagé leur transformation numérique et les nouveaux projets tendent à être nativement Cloud. Le régulateur impose toutefois des conditions, dont la localisation sur le territoire pour le Cloud public :  "Il ne s'agit pas du tout de limiter les marchés publics à des opérateurs nationaux...

Des remarques d'inspection de la US FDA mettent encore en cause les pratiques de "data and record management" pour ce fabricant chinois d'API : 1.      Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.   Your quality control laboratory failed to record and maintain complete data from analyses of your  (b)(4)  ( (b)(4) ) API. For example: Prior to conducting official analyses, your quality control laboratory performed “experimental” analyses on product batches to assess whether your API met specifications , but failed to document these “experimental” tests in official laboratory records or to justify their exclusion. Our investigator found the results of 2,404 high performance liquid chromatography (HPLC) injections in a folder titled “Experimental” on instrument SZG-002-006l. Your quality unit indicated that th...