On the occasion of the 2nd FDA Inspections Summit on 23 October 2007, Mary Malarkey from the Food & Drugs Administration's Center for Biologics Evaluation and Research (FDA CBER) held a presentation entitled "Challenges in Biologics Compliance".

In this presentation she also covered the most frequent deficiencies the Biologics team found during inspections. According to this, the most frequent deficiencies are:

• 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:"

Mary Malarkey further presented a study initiated by the authority - introducing the following results:

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

The presentation is available at http://www.fda.gov/cber/summaries/inspsumm102307mm.pdf

Prepared by:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)