Serialization and 2D Barcode requirements for finished dosage forms will soon be required under the Drug Supply Chain & Security Act, and the European Medicines Agency's Falsified Medicines Directive (FMD) also poses requirements.
But is your company prepared?
Now, the WIS Bookshop has compiled more than 600 pages of FDA, EMA, ICH and international guidance on supply chain compliance in this handy new manual and supplement.
You get the COMPLETE 2015 manual, DVD of important supply chain guidance, plus a 2019 supplement with:
* All FDA Guidance and compliance references on the Drug Supply Chain & Security Act (DCSCA)
* EMA and ICH guidance on the FMD and European supply chain requirements
* WHO guidance
* RFID and Blockchain technical assistance
* Serialization requirements
* Guidance to thwart counterfeiting and drug shortages
* Free six month subscription to GMP/Supply Chain Compliance Report.
Price is $497 for BOTH the 2015 manual and DVD and 2019 update and six-month subscription to Food & Drug Inspection Monitor (no obligation to subscribe).