In House Training Course

Update on EU GMP Guidelines and Inspection Procedures

(2 Hours – 0.5 Day)

Session 1

EU Regulations and Perspectives

• EU Guide to GMP
  • Ch 1 – Product Quality Reviews
  • Ch 7 – Complaints and Product Recall
  • Annex 19 – Reference and Retention Samples
  • Part II (ex Annex 18) – Active Substances

• Site Master File (SMF)
  • Why develop a SMF?
  • Components and structure
  • Links to Production and Quality Management Systems

• Manufacture of Investigational Medicinal Products (IMPs)
  • PSF requirements

 Session 2

EU Inspection Procedures and Trends 

• Process or Product related
• Format of Inspection reports
• Classification of Observations – Critical, Major, Other (Minor)
• Frequency of Inspections
• MRAs
• EU Procedures on Inspections and Exchange of Information

• GMP Compliance Inspections for Active Substances (APIs)
  • Key aspects of QS
  • Critical & non-critical steps
  • Inspection/audit report(s)
  • Contracts
  • Responsibilities of Qualified Person (products)

Speaker

Dr David Inglis