Friday, April 3, 2009

Pharmaceutical manufacturing

Just yesterday, some baby powder in US is found to have perchlorate above safe level of consumption. Read it here:

The find makes me reflect. Pharmaceutical manufacturing (including baby powder) is regarded as a very regulated industry where validation of each process and regular maintenance of the plant is required by regulation so as to ensure safe product is being produced. The baby powder and salmonella presence in the pistachio clearly show that the so called regulation does not exactlyu work well. After all, although the validation process where input and output is verified, I am not aware that the roles and responsibilities are regulated, i.e. noone care the independence and quality of the guy who does the work. You can probably get someone from the street and get him sign for you (correct me if I am wrong). I realize that at times company presents their validation strategy to the US FDA (Food and Drug Administration) and submit whole chunk of paperwork before they can start the validation process to confirm that what they will produce is safe or consumption (in short although there are lots more details to it). However, if these process is conducted correctly and regulated, why such clear disaster recipe such as the perchlorate and salmonella can happen?

Simply said, you can regulate process, you can not regulate people. People can choose to sign and not really able to vouch for it. People can choose not to reveal bad news (such as Salmonella in pistachio). Unless a good management system supported firmly by responsible top management is the only way to go. When people are aware of every consequence of their action, that is how we can prevent disaster. Simple validation and signature does not prevent bad things from happening especially when commitment from the top management may not exist. Furthermore, as my write up earlier point out, you can check for what you know you need to check. You can not possibly check everything. The most important issue is the responsibility. I view the Salmonella case as worse than the baby formula simply because their an indication of cover up. What we need in this world for the safety of all is responsible people who realizes the need to care for others, not just money.

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