April 6th 2025
3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.
USP Announces Proposed Standard for Supply-Chain Integrity
January 12th 2012The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.
Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product
August 1st 2011The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.