Are You Ready for Serialization Implementation?
Serialization implementation is probably on your radar already if you’re an executive at an emerging Biopharma company. Manufacturers need to…
Perspective
2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors
Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act…
Perspective
Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022
Per DSCSA, the U.S. pharmaceutical industry must be exchanging EPCIS data at the serialized package level by November 27,…
Perspective
Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements
While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November…
Perspective
DSCSA Saleable Return Requirements: What the Changes Mean
On October 22, the FDA issued a new guidance document: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and…