mardi 21 mars 2017

Scott Gottlieb nommé à la tête de la FDA...

Le président Trump a nommé récemment le Dr. Scott Gottlieb comme commissaire délégué à la US FDA ; plus d'information sur son profil ici.

lundi 20 mars 2017

Des écarts documentaires...

Des écarts documentaires pointés du doigt par l'US FDA dans deux injonctions récentes :

2.    Failure of your quality unit to prepare, review, and approve documents related to the manufacturing of API.
On August 16, 2016, our investigators found a large number of trash bags behind a building on your property. The trash bags contained torn original laboratory and production records, such as analytical test reports, (b)(4) water testing reports, and sample notebooks. The information on these discarded, torn documents did not match the official records. Your quality unit did not investigate these discrepancies. On August 18, 2016, when our investigators revisited the area where the trash bags had been, they found that the documents had been removed from the site. These findings indicate that your quality unit is not exercising its responsibilities...

3.      Failure of your quality unit to exercise its responsibility to ensure the API relabeled at your facility are in compliance with CGMP.
Your relabeling operation was not documented adequately. You did not document the time and date of relabeling operations, nor the employee who conducted relabeling operations for API you distributed. You did not sign and date records at the same time the activites were performed.

Plus d'informations ici et .

lundi 6 mars 2017

Ce fabricant d'API chinois pointé du doigt par l'US FDA...

Une seule remarque majeure dans cette "warning letter" pour ce fabricant chinois d'API :

Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.

Our investigators reviewed audit trails from various stand-alone pieces of laboratory equipment you used to perform high performance liquid chromatography (HPLC) and gas chromatography (GC) analyses. Our investigators found that you had deleted entire chromatographic sequences and individual injections from your stand-alone computers.

For example, your written system suitability procedure for (b)(4) requires only six injections. However, your records showed that on January 5, 2016, you injected seven system suitability standards when performing system suitability for batch #(b)(4). The audit trail showed that the final standard injection was permanently deleted from the instrument’s computer. Your analyst told our investigator that it is laboratory practice to perform more injections than are required by the procedure, and then delete any undesirable result to ensure passing system suitability results.
Without providing scientific justification, you repeated analyses until you obtained acceptable results. You failed to investigate original out-of-specification or otherwise undesirable test results, and you only documented passing test results in logbooks and preparation notebooks. You relied on these manipulated test results and incomplete records to support batch release decisions.

Plus d'informations ici.