Reduced Sampling of Key starting materials

Quality Control
#1

Details of existing system / procedure*
In the existing system, Key Starting Materials are being sampled from all Containers / Bags for each batch.

Details of changes proposed*
It is proposed to calculate the No. of containers to be sampled by using √N+1 Formula instead of sampling from all the Containers / Bags for the Key Starting Materials.

Reason / Justification for change*
It is proposed to reduce the No. of sampling to have minimum sampling load.

Is it acceptable as per GMP and any guidelines are referring on this matter, please suggest.

#2

That is acceptble for except ksm ,
100 percent sampling is required for KSM

#3

Dear @Srini
Either FDA or other high regulated authority bodies do not (and can not) tell you what sampling plan is to be used. The FDA requirement is that the plan be statistically valid and remember it’s mandatory to take sample from all the containers of key starting materials for doing identification testing.

#4

Thanks for your reply.
shall i justify with
based previous trend data
risk assessment

#5

Thanks for your reply.
shall i justify with
based previous trend data and risk assessment

#6

No, not acceptable for KSM


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