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.