Could you please help me to know the variation between initial 3 batches (batch to batch) testing during RM vendor qualification for critical tests as Assay, RS, moisture, OVI, RSL.
Basically, the analytical results of first 3 batches of Raw material under Vendor’s qualification should be consistent and meeting RM specification. If the results are not consistent but within speciation, which indicates OOT (Out of Trend) scenario. In that case, you can request for a few more samples from different batches of that RM to confirm consistency. At least, critical parameters must be consistent such as impurities, residual solvents and assay.