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RegisterGMP: EMA and FDA – mutual recognition of inspections [GxP / QC / QA]
Thumbs up for El Maestro post! 
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.
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.
Complete thread:
- GMP: EMA and FDA – mutual recognition of inspections Helmut 2017-03-03 11:42 [GxP / QC / QA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- GMP: EMA and FDA – mutual recognition of inspections nobody 2017-03-03 16:15
- USA ⇔ AUT, ESP, FRA, GBR, HRV, ITA, MLT, SWE Helmut 2017-11-10 11:19
- GMP: EMA and FDA – mutual recognition of inspections ElMaestro 2017-11-10 19:10
- GMP: EMA and FDA – mutual recognition of inspectionsDavidManteigas 2017-11-14 15:47
Ing. Helmut Schütz