FDANews
The QMN Weekly Bulletin

Industry Groups Slam Short Deadline for EU GMP Regs

Dec. 13, 2013
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. The proposal calls for cross-contamination toxicological risk assessments for any new product introduced into a facility.
Drug GMP Report