Cleaning validation is essential for patient safety and product quality within a GMP-compliant environment. Learn the principles, regulatory requirements, and how to document to confirm that your production cleaning processes are both effective and reproducible.
Cleaning validation is about ensuring that residues and carry-over do not affect the next batch. It is a critical GMP-requirement that comprise both product quality and patient safety.
This course provides a basic understanding of cleaning validation in the production of APIs, intermediates, and finished drug products.
You will learn how to validate the cleaning of equipment and facilities using a risk-based approach, ensuring that your cleaning processes meet EU and US GMP-requirements from regulatory authorities.
We will explore:
• Regulatory requirements
• Strategies for validating facilities and product-specific equipment
• Selection of equipment, cleaning agents, and cleaning methods
• Product dedicated vs. shared process equipment and facilities
• Analytical methods and acceptance limits
• From validation to practice – implementation in procedures
• Continuous cleaning monitoring
• Clean Equipment Hold time vs. Dirty Equipment Hold time
The instructors bring hands-on experience in cleaning validation and will share real-world industry case studies. The course format alternates between presentations and exercises, giving you the opportunity to apply theory in practice.
The course language is English.
At the course you will meet:
Carsten Germansen, VP Aptio Group CMC, MSAT & Tech Transfer, Aptio Group Denmark
Olof Rosén, PhD, Senior Consultant, Aptio Group Sweden AB
