Training based on international GMP regulations and industry technical reports.
EU-GMP Guidelines
- Chapter 1 – Pharmaceutical Quality System
- Chapter 2 – Personnel
- Chapter 3 – Premises & Equipment
- Chapter 4 – Documentation
- Chapter 5 – Production
- Chapter 6 – Quality Control
- Chapter 7 – Outsourced Activities
- Chapter 8 – Complaints & Product Recall
- Chapter 9 – Self Inspection
Annex & Technical Reports
- EU GMP Annex-1 (Sterile Manufacturing)
- PDA TR-1
- PDA TR-3
- PDA TR-22
- PDA TR-29
Lessons:
