cGMP: Kritik der FDA an Verwaltung und Schulung von SOPs

CONCEPT HEIDELBERG analysiert seit 2002 jährlich die Warning Letters der FDA an die Hersteller von Arzneimitteln und Wirkstoffen. Die Ergebnisse werden auch im Auftrag der ECA veröffentlicht. In diesem Zehn-Jahres-Zeitraum wurden immer wieder interessante Trends beobachtet.

Eine Durchsicht der Warning Letters der FDA des letzten Fiskaljahrs (2011) zeigt, dass Unvollständigkeit, Verwaltung und Schulung im Bereich der Standardarbeitsanweisungen (SOPs) immer noch brisante Themen sind. Neben der Nichteinhaltung eigener, schriftlicher Verfahren ("hat die SOP nicht befolgt", "Sie haben die SOP nicht eingehalten") werden häufig unzureichende Verfahren ("Ihre SOP ist nicht angemessen", "Die SOP erfüllt nicht ...") genannt. Wie die folgenden Auszüge zeigen, beziehen sich die hauptsächlichen Bedenken auf Unvollständigkeit, Verwaltung und Schulung. 

• "You have not provided a revised SOP"
• "Your firm has failed to validate your Standard Operating Procedure (SOP)"
• Your firm failed to establish written procedures used in the manufacture of drug products
• "The document that was provided to our investigators entitled […] appears to be an operating manual as opposed to a standard operating procedure that can be easily followed by your operators"
• "Your firm failed to provide a justification for deviating from your SOP"
• "The employees of your firm, including a member of your quality control staff, admitted to our investigators that they were unaware of and were not trained to follow your SOP"
• "Your firm states that additional training will be provided concerning SOP […] You have not provided a detailed explanation of your corrective actions or a timeframe of completion"
• "You have not yet provided this SOP"
• "Your response fails to specifically address how the proposed training will ensure that all employees will be trained in SOPs that are relevant to their job functions"
• "Your response fails to include timeframes for completing training"
• "Your firm has failed to address the employee training regarding the two revised Standard Operating Procedures"
• "You have not defined what specific information will be included in your CGMP training"
• "Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience"
• "Your response fails to specifically address how the proposed training will ensure that all employees will be trained in SOPs that are relevant to their job functions"
• "Your response fails to include timeframes for completing training"

Wolfgang Schmitt
CONCEPT HEIDELBERG