What if the hardness of tablets fails during compression,what action a QA person takes?
Check compression machine settings.
Get unplanned process deviation raised by production.
Who will be initiator of deviation.and CAPA?
In both cases production.
I think the responsible for Capa report is QA person not production
First production person will have to initiate both the documents and then only futher qa person will provide comments.
- Stop the compression machine
- Intimate Prod head and QA head
- Quarantine the compressed tabs since last IPC check
- deviation to be raised by Prd.
- Investigation and CAPA, decision.
- Resume compression after verification of complete IPC Checks.
What are the causes of Hardness Fail?
1.Compression machine setting problem (precompression and main compression problem)
2. Problem in the granules itself.(No proper granulation)
3. Environment conditions, for sensitive product
For a set validated batch following may be the reasons
Poor powder flow from hooper so die is not filled properly.
some time any blokage in feeder housing reduce flow of powder.
Granules have more fine.
No proper moisture level in grains.
Pre compression and main comp. setting problem.
First of we should stop the machine and search the main reason behind the not getting hardness of tablets.
Based on any freeze reason , we should work to correct i.e. Poor flow granule, Granule demixing process. within hopper, pre-compression parameter,main compression parameter, LOD/Water by Kkgf vakue if bledn, environmental manufacturing condition. If problem till a exist we raise the deviation to run the product with deviate hardness of tablets.
Based on deviation flow i.e. quarantine compressed tabs, remaining blend granules etc to be investigate and accordingly CAPA raise for further batch manufacturing process.
what should be range of hardness?
Depend upon formulation.Varry product to product.
Q. what should be range of hardness?
A. Its all depend upon the requirement i.e. product release profile w.r.t.target action,release profile w.r.t. RLD & other requirement.