Worst-case process condition

my question is - should cleaning validation protocols include worst-case process condition such as maximum batches or elapsed time in a campaign?

Jovana Spajic
Senior expert associate
Hemofarm Vrsac, member of STADA group


Hello, Jovana,

validation protocol should be included validation method, such as product matrix approach or individual product approach, it is very important in cleaning validation. if you choose the matrix approach, worst case production and other information are need to in the protocol.


APIC cleaning validation guide 2014 can provide a basic guidance for the contents of a cleaning validation protocol. Also, refer PDA tech report 29 for points to be considered in cleaning validation.

Veerraju N