Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-20 11:47 CEST (UTC+2h)

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

posted by DavidManteigas - Portugal, 2017-11-14 15:47  - Posting: # 17980
Views: 823

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,397 posts in 3,909 threads, 1,174 registered users;
online 39 (2 registered, 37 guests [including 22 identified bots]).

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed