Pearls of Wisdom
IHIF Annual Meeting: Monday, May 7
Please join us for the IHIF Annual Meeting on Monday, May 7 and Tuesday, May 8. IHIF will release its 2011 Annual Report and present the Statewide Strategic Plan for Indiana's Health Science Sector. Pearl will have 3 or 4 teammates on hand so be sure to look for us...
Interactive Map Shows Global Distribution of 2011 FDA cGMP Warning Letters
A map has been released to display the locations of all FDA cGMP (Current Good Manufacturing Practice) warning letters issued in fiscal 2011. It is evident that the FDA is continuing its crackdown on overseas manufacturing plants as warning letters increased by 40%...
EMA Attempts To Support Continuous Process Verification With New Guidelines
The European Medicines Agency (EMA) has released draft guidelines regarding continuous process verification (CPV) to bring its policies in line with ICH Q8, Q9, and Q10. The goal is to gain information a manufacturer can use to make adjustments during production to...
RAPS Indiana Chapter Meeting: May 14th
The next RAPS Indiana Chapter meeting has been scheduled for May 14th, 2012 from 4:00-6:00PM at IUETC Ice Miller Room. Please save the date for this discussion. Jody Roth will be speaking about "Key Regulatory Trends in 2011 Biological Approvals." To register, click...
EMA Attempts to Enhance Biosimilar Process
In its biosimilars advice document, the EMA answers 43 questions about the process for approving biosimilars. Part of this process includes biosimilar GMPs (good manufacturing practice) as well as inspection requirements in Europe. For facilities located outside of...