Process Validation on Manual Mixing Process

Hello folks,

I have one solid dosage product (only with one API) that only manual mixing is involved, i.e. put the raw materials in a PE bag, manual shake for several oscillations/period of time, and after the manual mixing, the mixed powder goes to tablet compressing. The batch size is approx. 8.5mg (approx 65000pcs) and the API dosage of tablet is 10mg and the tablet weight is 130mg.

I would like to know, focused on the manual mixing process, how would the PV proceed? How many sample points are recommended after the mixing process?

Thanks a lot for your advices!