lundi 24 avril 2017

La MHRA publie son rapport annuel des tendances d'inspections

Dans ce rapport, on trouve notamment les observations se rapportant à l'annexe 11 des BPF :


Avec les observations mentionnées suivantes :

Deficiencies related to data backup: 
  • Following a software update, data was lost from an autoclave control system.
  • The system backup was unable to recover lost data as the backup was only performed on a 3 monthly basis.
  • The backup CD/DVD for the autoclave control system was not stored within a controlled environment to assure its integrity. 
  • Data from the integrity test was not backed up. The system was observed to overwrite previous data. 
  • Backups were required to be reviewed for accessibility annually for 5 years however this failed to ensure that data that is required to be stored for longer such as validation data, was accessible for its full retention period. 
  • Backups were permitted to be made on the same computer drive which failed to ensure that a separate copy was available following drive failure or corruption. 

Deficiencies related to inadequate control of computerised systems: 
  • Access to files and the system clock on the hard drive were available to all users. 
  • The lock screen used a shared password. If a user had logged into the software behind the lock screen and another user opened the computer, they could perform actions under the initial user’s login.
  • Users had more authorisation on the chromatography data system than was permitted according to the SOP.
  • Access control systems were not considered GMP systems despite their intended purpose to control access to GMP areas. 
The HPLC software within the laboratory was not configured for GMP Compliance: 
  • Unique user passwords were not enforced. 
  • Users were permitted to change the default audit trail. 
  • Users were permitted to change the default “require user comments”. 
  • Users were permitted to copy non related projects. 
  • Users were permitted to use annotation tools. 

Plus d'information ici.

jeudi 20 avril 2017

Un article intéressant de la MHRA sur les attentes en matière de validation des systèmes informatisés

Cet inspecteur GCP de la MHRA détaille une étude de cas de CSV et précise les observations fréquentes des inspecteurs sur ce sujet.

Il est disponible ici.

La gestion des OOS et la revue des audit trails au cœur de cette nouvelle injonction de l'US FDA

Cette injonction adressée à un site américain mentionne des manquements importants dans la gestion des OOS et de la revue des audits trails :

 1.    Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
 
From January 1 to June 30, 2016, your firm invalidated 101 out of 139 (about 72 percent) initial out-of-specification (OOS) assay results without sufficient investigation to determine the root cause of the initial failure.
 
For example, you opened laboratory investigation report PR 908027 for an initial OOS six-month stability assay result of (b)(4) percent (specification (b)(4)(b)(4) percent) for (b)(4) mg tablets, lot (b)(4). You invalidated the initial failing result without adequate investigation, performed re-testing, and then reported the (b)(4) results of these replicate re-tests ((b)(4) percent). Your investigation did not reach an assignable cause, nor did you take appropriate corrective actions and preventive actions to ensure that the significant “analytical bias” to which you ultimately attributed the initial failure would not affect other analytical work in your laboratory....

2.    Your firm failed to establish an adequate quality control unit with the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).
 
Your quality unit failed to monitor and investigate error signals generated by the computerized systems that you use for high performance liquid chromatography and gas chromatography. These signals indicated the loss or deletion of original CGMP analytical data. However, your quality unit did not comprehensively address the error signals or determine the scope or impact of lost or deleted data until after these problems were reviewed during our inspection.
                                                   
For example, our investigator reviewed audit trails from August 2016 assay testing on (b)(4) batch (b)(4) and dissolution testing for (b)(4) tablets batch (b)(4). The audit trail for these tests included the message, “deleted result set,” but neither of these two incidents were recorded in the analytical packages for these batches of drug products, nor were they reviewed or investigated by the quality unit...

Pour en savoir plus, cliquez ici.

Pour participer à la prochaine journée eCompliance sur le thème "Data Integrity", cliquez ici

mercredi 19 avril 2017

Journée A3P Data Integrity à Lyon le 20 Juin 2017

en tete
newsletter fr
L’intégrité des données, au format papier ou électronique, est devenue en quelques mois un sujet majeur pour les industries du médicament et des produits de santé.
Les autorités de tutelle ont mis en évidence des dysfonctionnements, ont publié des guides et notifient régulièrement les industriels sur cette thématique.
  • Comment s’y retrouver entre les textes (BPF, cGMP, 21CFR11...) et les nouveaux guides (EMA, PIC/S, FDA, MHRA, WHO...) ?
  • Quels sont les attendus ?
  • Que nous apprennent les retours d'inspection ?
  • Quelles sont les approches prises par les industriels pour y répondre ? En particulier, pourquoi et comment revoir les "audits trails" ?
  • Quels sont les réponses techniques et organisationnelles pour maitriser l'intégrité des données ? au laboratoire et en production ?
Au cours de cette journée, nous vous apporterons des réponses via des retours d’expérience d'industriels (Baxter, GSK, Lilly, Merck, Sanofi...) et de fournisseurs (Waters, Werum...) représentatifs du secteur.
    
20 JUIN 2017 - LYON

Conférences :
  basics Data Integrity : le point sur les textes réglementairesLionel Pelletier - Aktehom
  basics Mise en oeuvre d'un plan de remédiationThierry Dufrasne - Baxter
  basics Ce que peut proposer un fournisseur d'équipements de laboratoireDominique Agro - Waters
  basics Data Integrity au laboratoire : retour d'expériencesSylvain Plagellat - Merck
  basics MES – The Data Integrity engine for production control strategy executionChristian Wölbeling - Werum
  basics Data Integrity en production : retours d'expériencesJean-Marc Jehl - Lilly
  basics La revue des audits trails : Pourquoi ? Comment ?Alain Navarro - Sanofi
  basics Retours d'inspectionsPatrick Turlier - GSK
 
 PROGRAMME
& INSCRIPTION 
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Téléchargez le dossier exposant
   
Mylène RATmrat@a3pservices.com - +33 (0)4 37 28 30 43
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