For the sake of citizens or a high-level retaliatory activity? [GxP / QC / QA]

posted by nobody – 2018-01-18 11:13 (2313 d 04:02 ago) – Posting: # 18203
Views: 5,959

...if you read inspections reports from US facilities (finding canisters with pee in production areas, incredible conditions in sterile production andandand...) in the context of appalling rates of product withdrawals due to microbiological contamination or "particulate matter" in solution for parenteral use (just as an example) every additional inspection of any production facility anywhere in the world has to be highly appreciated.

Keep the pressure high to stop quality from deteriorating.

I think it's very difficult to answer, where you get the most bang for the buck when it comes to pharma inspections. The whole system is so totally borked by putting ever more financial pressure on the production imho...

Edit: Please don’t shout! [Helmut]

Kindest regards, nobody

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