Our investigation and CAPA should be like that to avoid the re-occurrence of event with the same reason.
Here the case study…“Fixing problem “is the main activity at pharmaceutical industry now a days, Rather than manufacturing medicine, we are focusing on the failure investigations, root cause identification, CA-PA implementation & effectiveness verification. When a facility or a product is designed, the risk based approach not followed. Maximum problems happed during tech transfer from R&D to commercial manufacturing. Failure is happened due to higher variability in utility, machinery & area maintenance, operation and control. This is the time when we start taking support with short cut (quick-fix solutions).
Re-dilution from stock:99.5%.
From above Re-measurement testing root cause is identified as sample dilution error.5-Why root cause analysis for above case study.1-Why–Problem
OOS (79.0% result) observed in assay test
2-Why 79.0% result.
Analyst had done wrong sample dilution (prooven in hypothesis testing)
3-Why analyst had done wrong sample dilution.
During investigation it has been observed that analyst had 2 pipettes (4ml and 5ml) in his working tray. Hence analyst had used 4ml pipette for sample dilution instead of 5ml pipette, resulting 20% lower Assay.
4-Why analyst had 2 pipettes in his tray.
Analyst have 2 different products for analysis and he had kept all preparations in a same tray.
5-Why.….Not applicable.So from above investigation exact root cause is identified in 4th-Why only.
Based on root cause, proper and effective CAPA should be taken.
Then what will be the thought process of CAPA as a pharmaceutical professional. · We will fix the first cause is Human error / person does not know how to move in bathroom –Blame on Training adequacy· After that, we will propose extensive Cleaning of bathroom – Inadequate Process· Then, change the detergent of bathroom cleaning will be additional control – Blame on the external supplier and material use.· Increase frequency of cleaning to avoid the slippery floor – Inadequate maintenance program· Training how to move in slow motion in bathroom – Inadequate process control
· Visible board mentioned “Wet floor, move slowly” and mention Ambulance number in case of emergency – Additional control to make process more complex and to satisfy auditors
· Increase the lighting for better visibility – Additional budget investment and increase annual maintenance cost
· Installed telephone to take help from neighbor – Involves of external consultant to fixed internal problem
· One person will stand outside of bathroom to support in case of emergency – Proposal of increase of manpower to management
But we did not think for permanent solution.
In current scenario change in bathroom floor tiles with Rough Surface new tiles can be an appropriate CAPA.
In fact design and installation of bathroom should to be with rough surface tiles only as part of risk based approach. But here the attitude which comes that is it’s ok. Because to fix the actual problem productivity can be temporary decrease but in future same problem will not be happened.
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