Deux Warning Letters récentes ont attirées notre attention
La première porte sur une entreprise dans le secteur des dispositifs médicaux et sur la gestion du changement :
4. Failure to establish and maintain adequate procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i)
Your “Engineering Change Order” procedure 5.1, Rev 0, dated 7-25-09, does not address verifying and/or validating design changes. In addition, four of the design changes and four of the corrective action design changes reviewed have not been verified and/or validated.
La deuxième sur la gestion des étiquettes "Master Records" gérées par un système informatisé :
1. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R § 211.68(b)].
For example, repackaging technicians changed master labels of repackaged products, which resulted in product packages labeled with incorrect strength or incorrect spelling of the drug name. You then released these mislabeled drug products for distribution. Examples of incorrect labeling that resulted from technicians changing the master label include...
Il s'agit là de deux points sensibles pour la plupart des industriels et qui démontrent (si cela était nécessaire) la pertinence des inspections récentes de la FDA sur ces sujets.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309300.htm
Nos prestations en matière de conformité réglementaire des enregistrements électroniques (EU, FDA).
4. Failure to establish and maintain adequate procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i)
Your “Engineering Change Order” procedure 5.1, Rev 0, dated 7-25-09, does not address verifying and/or validating design changes. In addition, four of the design changes and four of the corrective action design changes reviewed have not been verified and/or validated.
La deuxième sur la gestion des étiquettes "Master Records" gérées par un système informatisé :
1. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R § 211.68(b)].
For example, repackaging technicians changed master labels of repackaged products, which resulted in product packages labeled with incorrect strength or incorrect spelling of the drug name. You then released these mislabeled drug products for distribution. Examples of incorrect labeling that resulted from technicians changing the master label include...
Il s'agit là de deux points sensibles pour la plupart des industriels et qui démontrent (si cela était nécessaire) la pertinence des inspections récentes de la FDA sur ces sujets.
Pour en savoir plus sur :
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309060.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309300.htm
Nos prestations en matière de conformité réglementaire des enregistrements électroniques (EU, FDA).
