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

posted by DavidManteigas – Portugal, 2017-11-14 16:47 (1960 d 14:32 ago) – Posting: # 17980
Views: 3,387

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.

Complete thread:

UA Flag
 Admin contact
22,557 posts in 4,724 threads, 1,607 registered users;
24 visitors (0 registered, 24 guests [including 8 identified bots]).
Forum time: 08:20 CEST (Europe/Vienna)

The function of genius is not to give new answers, but to pose
new questions which time and mediocrity can resolve.    H.R. Trevor-Roper

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz