FDA kritisiert SOP-Training in pharmazeutischen Unternehmen

Seit 2002 wertet CONCEPT HEIDELBERG in jährlichem Turnus die Warning Letters aus, die die FDA an Arzneimittel- und Wirkstoffhersteller versendet. In diesen 9 Jahren konnten interessante Tendenzen festgestellt werden.

Die Auswertung der FDA Warning Letters des letzten Fiskaljahr zeigt weiterhin Lücken im Management und Training von Standard Operating Procedures (SOPs) auf. Zusätzlich zur Nichteinhaltung der eigenen schriftlichen Verfahren (

"SOPs not followed", "you failed to comply with SOP") und unzureichende Verfahren ("your SOP is inadequate", "SOP fails to …"), die häufig zitiert werden, betreffen die größten Anliegen Management und Training - S. folgende Auszüge: 

• "There are documented instances of failure to follow SOP […] and employee Training"
• "Your firm's quality control unit failed to approve procedures"
• "SOP revisions are not performed and documented appropriately"
• "Your QCU did not date or approve two of your SOPs"
• "We recommend that you hire a qualified consultant to provide comprehensive CGMP training … . Further, we recommend that once the training is completed, you conduct a comprehensive evaluation of all of your written procedures to ensure they are adequate, complete, and in compliance with the CGMP regulations."
• "There are no records that show that CGMP training specific to the employees' duties was performed"
• "When presented with an unsigned SOP entitled "Training," which requires CGMP training of employees, both the GM and the Production Supervisor stated that they were unaware of this document."
• "In your response of […], you state that your firm will revise its training program to provide and track employee training in CGMP and specific job functions. This response is inadequate in that it fails to state when the training will be completed. It also fails to explain the measures you will take to ensure product quality while operations continue with employees not adequately trained."
• "You have not established completion dates and training programs for current good manufacturing practices and SOPs"
• "Your SOP and batch […] instructions are in English (the official language in Singapore). However, one operator who works in the processing of the plaster line for the finished product of […] cannot read English."

Wolfgang Schmitt
CONCEPT HEIDELBERG