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Anlässlich des 2nd Annual FDA Inspections Summit am 23.Oktober 2007 gab Mary
Malarkey vom Center for Biologics Evaluation and Research (CBER) der FDA eine
Präsentation mit dem Titel Challenges in Biologics Compliance.
Im Rahmen der Präsentation wurden auch die häufigsten
Beanstandungen bei Inspektionen durch das Team Biologics präsentiert. Die drei
häufigsten Beanstandungen sind demnach:
- 211.192
"You failed to thoroughly investigate any unexplained discrepancy or the failure
of a batch or any of its components to meet any its specifications, as follows
…"
- 211.22
"The deficiencies described in this letter are indicative of your quality
control unit not fulfilling its responsibility to assure the identity, strength,
quality, and purity of your drug product"
- 211.100
"Your firm failed to establish and follow written procedures, and to justify any
deviation from written procedures, for production and process controls designed
to assure that the drug products have the identity, strength, quality, and
purity they purport or are represented to possess:"
Darüber hinaus informierte Mary Malarkey über eine Studie, die
die FDA initiiert hat. Dabei wurden die folgenden Ergebnisse vorgestellt:
What changes in operations/procedures were made as a result of
Team Biologics inspections?
- 67% reported changes in failure investigations and this
seemed primary focus for most sites
- 72% reported changes in production and process controls
- 61% reported changes in written procedures
- 39% reported changes in each of the following: management
of priorities, training and quality unit activities
Die Präsentation kann hier herunter geladen werden:
http://www.fda.gov/cber/summaries/inspsumm102307mm.pdf
Zusammengestellt von:
Oliver Schmidt
CONCEPT HEIDELBERG
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