FDA Updates Messaging to Compounders Nationwide
The FDA recently updated the FDA to Compounders: Know Your Bulks and Excipients Suppliers page, which now includes links to guidance documents, examples of past quality issues, and a log of FDA actions against trading partners for violations of Good Manufacturing Practice Requirements (GMP).
FDA Guidance Under Current Good Manufacturing Practice
The FDA released a finalized questions and answers guidance on data integrity compliance. The FDA guidance adheres to requirements under current good manufacturing practice ( cGMP) for drugs and biologics.
In Recent Guidance, FDA aims for Patient Safety at 503B Facilities
The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB)
Take Control of Patient Safety and Quality Control with InsightRX
Just last week, ConsortiEX proudly announced our new InsightRX Passive Audit Monitoring module.
Address Quality Control, Re-insourcing CSP Production with a Central Fill Model
Today, cost and quality issues surrounding compounded sterile preparations (CSP’s) have nearly every major health system investigating what it takes to re-insource production. Most are looking at a hub and spoke approach, where their central-fill Batch Compounding can support the CSP production needs of all the[...]
Come see what You've been Missing, ConsortiEX is Attending ASHP Midyear
ConsortiEX is proudly attending ASHP Midyear. Stop by Booth 900 to see how our intuitive Pharmacy-Focused ERP solutions can enhance your patient safety, ensure quality control, and simplify compliance, first-hand and in-person. Our new InsightRX Passive Audit Monitoring hood will be on display.
InsightRX Passive Audit Monitoring: See What Others Miss
Introducing InsightRX Passive Audit Monitoring: See what others miss.