First page of the Report "4 GMP Case Studies Including FDA Findings and Concerns"

Report - 4 GMP Case Studies Including FDA Findings and Concerns

By

Jerry Chapman

,

Areas examined in the case studies are:

  • Inadequate change management systems
  • Cross-contamination in solid oral dosage facilities
  • Inadequacies and potential contamination hazards in aseptic manufacturing
  • Perforated tables and work surfaces in cleanrooms
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