GMP Inspection Excellence for Highly Potent API Manufacturing

Time: 9:05 am
day: Day Two

Details:

– Introduction to WHO Prequalification Programme (PQP) and inspections of pharmaceutical manufacturers for WHO PQP
– WHO Guidelines used for inspection of highly potent or hazardous substance
– Newly adopted points to consider documenting for manufacturers and inspectors on environmental aspects
– Frequent challenges for the industry; how do these challenges differ for inspection in Asia vs US?

Speakers: