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).
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.
The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB)
Just last week, ConsortiEX proudly announced our new InsightRX Passive Audit Monitoring module.
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[...]
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.
Introducing InsightRX Passive Audit Monitoring: See what others miss.