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GMP: EMA and FDA – mutual recognition of inspections [GxP / QC / QA]

posted by DavidManteigas - Portugal, 2017-11-14 15:47  - Posting: # 17980
Views: 1,065

Thumbs up for El Maestro post! :clap:

Although I may understand the cost issue, I can't understand why pharmaceutical companies that outsource most of their R&D and manufacturing activities don't think and behave as you've described. They should be as interested as the regulatory authorities in assuring that the highest standards are followed by their vendors. When something goes wrong, and as the "vigilance" decreases the probability of lack of compliance increases, it's their brands and products that feel the consequences, as well as the market as a whole. Unless they all believe that there isn't such thing as bad publicity.

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