PQ batch size

GOOD VALIDATION PRACTICE (cGVP)
1

Hi all,

I’m doing a PQ protocol for a filler machine and I would like to know if it’s neccesary to run cycles of similar size to my comercial batches or it would be enough with the aproximation af 10% of the real batch. Is there any place to read about it?

Thanks in advance!

2

Do not be tempted to run a 10% of a real batch for the PQ! You MUST run a PQ with a batch size equivalent to a “real” production run at the very least.

Ideally you should determine what the largest commercial batch size would be likely to be and run that for your PQ.

Running a PQ with a “small” batch which is not a typical commercial batch would not give you (or regulatory bodies) the confidence that the machine was adequately validated. It is better to validate to a worst case batch size so that when you normally run smaller batches you can be confident the equipment will easily cope with that smaller batch

I understand why you ask the question to save time and cost, but that wont count if the equipment is not adequately validated in the eyes of the FDA inspector!