Can we skip in-process sample analysis,before going to packing (filling) of ointment we need in-process results of manufactured ointment, but without in-process analysis can we directly go for the packing and finished sample (I mean finished sample results with COA-certificate of analysis) after that can we commercial that batch with finished COA , is this acceptable thing in pharmaceuticals?
Dear Shruthi,
Can be, but below Conditions applied:
- Manufacturing process and filling process must have completed validation before with same batch size, equipment’s, process parameters and all.
- Conditional approval/ Release for filling from QA.
- Check your in-house SOP for release whats written, deviation to be filled.
- Full testing to be done before release to the market.
Thanks
as per above u mentioned conditions are ok but in case of point no-3 we should raise deviation because not only SOP in batch manufacturing Record we were mentioned that after unloading of product send sample to QC hence it means we skipped one operation of BMR so we are deviated our written procedure i.e, BMR
Dear @shruthi,
We can not skip analysis due to if manufacturing product is not complies with assay than without assay how can you pack and finish the product???
In process sampling, analysis and after finish analysis is mandatory.
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For this question my sir given explanation that Inprocess sample is our internal requirement not FDA requirement soo if any failure in assay we should reject batch. That’s our burden … No impact for customers
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thats why is logic base but fail in assay then you dont packing the product is more man power and material waste so therefore required to test.
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You can but you have a big risk on your batch, what if the test results failed and you have finished packing the product, then you must conduct reprocessing procedure. Additional cost to your product.
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inprocess sample analysis is good practice. dont skip it. reprocessing will be costly in case of failure.
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like Bismuth in ointment.