Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors
Nanjing, November 2009
Poorly designed or executed PM monitoring
Reliance on the use of contact plates and no use of swabs
Reliance on active air monitoring and inadequate use of settle plates
“Averaging into compliance” – inadequate attention to the individual high count
Acceptance of “good pattern” of very low contamination and failure to evaluate whether the programme is effective.