Pharmaceutical Resource & Education Services

“Fixing problem “is the main activity at pharmaceutical industry now a day. 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 observed 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 of जुगाड़ (quick-fix solutions).

Suppose problem statement is “you have fallen down in Bathroom due to slippery floor”, what will be the thought process of CA-PA as a pharmaceutical professional,

• First cause is Human error / person does not know how to move in bathroom –Blame on Training adequacy
• Then we will propose extensive Cleaning of bathroom – Inadequate Cleaning Process & practices 
• Change of 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 CA-PA. 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 चलता है. Because to fix the actual problem productivity can be temporary decrease but in future same problem will not be happened.