How to perform stratified sampling at compression stage with all challange study for batch size of 130000 tablets on double rotary 45 station compression machine? Plz explain if any have idea …
Stratified sampling is a technique used in pharmaceuticals to ensure that the study sample is representative of the entire population. The sample is divided into subgroups, or strata, and each subgroup is sampled independently. This ensures that the results from the study are accurate and not influenced by any bias in the sample.
You can divide the tablets into 3, 4 or 5 equal groups and add different variables to these groups like the speed of the compression machine.
Sir actually batch size 130000 tablets is to be completed On above said machine within one hour … So how many sampling point interval is define?
No such specific guideline is available for it, you can take 3 samples in 20 min, 40 min and 60 min with min, medium and high speed.
I think it is important to know what is the purpose of that sampling; is it for equipment qualification?, for routine process control? for process development?, is it a PPQ lot?
I strongly suggest that if that sampling is done for PQ purposes, do not change process parameters (e.g. speed) within each run (batch); since you will not be able to evaluate if the variation observed is due to natural variation (random variation) or due to a change in process parameters.
If that sampling is for PPQ (process performance qualification), these batches have to be commercial and must be manufactured under nominal conditions, without challenging the maximum or minimum operating conditions or parameters; those operating conditions must have been validated during equipment PQ before manufacturing commertial batches.
Sir this batch will be taken for process development …