Uniformity studies

GOOD VALIDATION PRACTICE (cGVP)
1

Hi!

I have a doubt, in the process validation of API`s when is realized a uniformity studie what is the acceptance criteria?

the uniformity studies normally comprise to evaluate the purity, loss on dried, particle size and densities to differents parts and levels of containes.

normally we obteined 10 - 12 samples of each lot, however, our actual acceptance criteria is that the samples met specifications but i don´t known if is necesary employ other criteria for example no more than 2% of variation between samples.

what is the correc in this case?

thanks for your help.

2

hi,

Acceptance criteria for uniformity would be +/- 2% for each sample in the respective assays.
Or you could use a ratio of means (0.09-0.10) % RSD etc should usually be 2%.

Ruth