Current Good Manufacturing Practices in Pharmaceutical Manufacturing Industry Under Focus

In the wake of the recent recall, illnesses and deaths stemming from contaminated medications received from the compounding pharmacy New England Compounding Center, pharmaceutical manufacturing regulations and compliance issues are coming into focus.  According to a news briefing from the U.S. Department of Justice (DOJ) Deputy Assistant Attorney General Maame Ewusi-Mensah Frimpong, the top areas of focus for the DOJ this year will be drug safety, in particular misbranding and adulteration of drugs.

Frimpong states, "In the area of misbranding, when companies make promotional claims that are not truthful and balanced, or when they do not disclose all relevant safety information to FDA and doctors, they place patients at great risk of harm because neither doctors nor patients can make informed choices about their drugs.  Similarly, when companies fail to follow current good manufacturing practices, they often place patients at great risk of harm that neither they nor their doctors have any way of mitigating or even recognizing."

For pharmaceutical manufacturers, having systems in place to manage all of the regulations and compliance issues will be important.  EVS's O2 Life Sciences & Pharmaceutical ERP software system for Sage 500 ERP was developed with the strict quality and regulatory requirements, including Current Good Manufacturing Practices (cGMP).  This pharmaceutical manufacturing software system also:

• Manages CFR 21 Part 11 compliance
• Offers Enhanced Implementation Documentation (GAMP 5 Requirements for Commercial Off the Shelf (COTS) Software)
• Formula Security & Management
• Cradle to Grave Lot Tracking
• Auditing & Security
• Validation

It is clear that more regulations and a more watchful eye will be looking over the pharmaceutical manufacturing industry.  The more ways those manufacturers can be prepared and have systems in place to manage these challenges the better.  For more information on the pharmaceutical manufacturing ERP software, visit www.evs-sw.com.