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MHRA Top Findings Report

Keep up with regulatory trends with a comprehensive analysis of the most common inspection findings regarding EU Regulations for 2018 and 2019.

In this report you’ll find data, charts, comparisons and comments made by our top experts on:

  • check markChapter 1 — Pharmaceutical Quality System
  • check markChapter 3 — Premises & Equipment
  • check markChapter 4 — Documentation
  • check markChapter 5 — Production
  • check markChapter 6 — Quality Control
  • check markChapter 8 — Complaints & Product Recall
  • check markAnnex I — Sterile Manufacturing
  • check markAnnex XI — CSV
  • check markAnnex XV — Qualification & Validation
  • check markFDA Warning Letters Citations
  • check markFDA 486 Observations
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