During PPV for new product after trail batch execution, minimum 3batches to be executed to validate the process…
Here my question is…In PPV That 3 batches to be taken in consecutive days ? Or… Proceed to next batch only after getting previous batch output analysis ?
Basically, once the critical processespecially and its parameters are identified in trial/ optimization batches these are to be carefully monitored and controlled during Precess validation of consecutive three batches. And by doing extensive sampling, testing/analysing and assessments in PPV we establish that the process satisfatorily works to get desirable output or a product consistently with predefined specifications. So, there is no need of waiting period between two batches. We can assess the results at once of three batches or one after other. During PPV we should not alter or modify any processing step or any critical process parameters.If we make alterations means, the process is not consistent and hence is not valid.
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It will good to initiate second batch after getting result of out put of first batch , because it will help you to improve and to get confident for next batch and also if any thing goes wrong on first batch , we can stop second batch till corrective action , specially for prospective validation.
Proceed to next batch only after getting previous batch output analysis .In case of PPV we can set only parameter like temp. vacum ,spped etc.So it is very important to review previous batch test results.
If, u have more confident level on process you can go for continues but hear, this material no need to move further step, move after getting 3 batches output only after compile of quality data
This means that process was not optimized prior to PPV. If you adapt your process after one run, you need to start PPV over, so another 3 consecutive batches. All PPV batches must be produced using exact same process.