Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities. It is not unusual to hear of cGMP and quality failings in API and ...
WILMINGTON, N.C., March 30, 2011 /PRNewswire/ -- AAIPharma Services Corp., a leading provider of pharmaceutical product development and manufacturing services, has relocated its compendial raw ...
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a ...