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This came to me when I was doing some routine work yesterday; I work in the QC lab for a drug company which makes drugs for HIV and hepatitis. The lab is under GMP which means everything is tested multiple times and the amount of paperwork involved is staggering.
When a bulk truck of acetone shows up it needs to be tested for identity (30 minutes), water content (30 minutes), purity by GC (3-4 hours), then checked by another QC person (1 hour), then sent to QA and checked by QA (1 hour). This is what we do for everything that happens. We extensively test all raw materials that come in. Not just 1 sample from the lot but 1 sample from every bag and container in the lot (14+ samples for a pallet, for example). If a test fails, we fill out a report of what happened, why it happen, get it signed by the QC supervisor, get it signed by the QA supervisor, get it signed by the clerk, then we can try the test one more time. Every piece of equipment in the lab is calibrated every single day before use (don't need to calibrate if it's not being used that day). All papers and corrections are manually dated and initialled, which means a single GC report for a sample could have as many 30 signatures on it.
For the entire plant of roughly 170 people, 30 of them are from QC, at least 20 from QA, and R&D makes up probably about 30 as well. The amount of testing involved under GMP is absolutely ridiculous. If you want to know why your drugs are $30/pill, it's because the government requires that every single bag of every single material has been tested multiple times. Every intermediate has been tested multiple times. Cleanliness of all equipment is tested. Final products are tested even more times with more tests with tighter standards. The cost of time is high, and your drug bill reflects this.
When a bulk truck of acetone shows up it needs to be tested for identity (30 minutes), water content (30 minutes), purity by GC (3-4 hours), then checked by another QC person (1 hour), then sent to QA and checked by QA (1 hour). This is what we do for everything that happens. We extensively test all raw materials that come in. Not just 1 sample from the lot but 1 sample from every bag and container in the lot (14+ samples for a pallet, for example). If a test fails, we fill out a report of what happened, why it happen, get it signed by the QC supervisor, get it signed by the QA supervisor, get it signed by the clerk, then we can try the test one more time. Every piece of equipment in the lab is calibrated every single day before use (don't need to calibrate if it's not being used that day). All papers and corrections are manually dated and initialled, which means a single GC report for a sample could have as many 30 signatures on it.
For the entire plant of roughly 170 people, 30 of them are from QC, at least 20 from QA, and R&D makes up probably about 30 as well. The amount of testing involved under GMP is absolutely ridiculous. If you want to know why your drugs are $30/pill, it's because the government requires that every single bag of every single material has been tested multiple times. Every intermediate has been tested multiple times. Cleanliness of all equipment is tested. Final products are tested even more times with more tests with tighter standards. The cost of time is high, and your drug bill reflects this.