ConsortiEX is proud to announce T3 verification, the newest feature to be added to our DSCSA Compliance as a Service (CaaS) module. The T3 Verification process gives pharmacies maximum visibility to all T3 transactions, both electronic and paper, received by their pharmacy. Under the Drug Supply Chain Security Act (DSCSA), health system pharmacies are required […]
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. Raps writes, “The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to […]
The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB) Healthcare Packaging explains: “A Dec. 10 statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram focused on the importance of ensuring compounded product quality. FDA noted that it continues to implement its 2018 Compounding Priorities Plan as part of […]