Manufacturing

Articles

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

FDA Publishes Guidance Documents to Enhance Supply Chain Security

USP worked with a patient advocacy group and a purchasing organization to create a predictive model for improving supply chain resilience for critical pediatric oncology drugs.

USP, Angels for Change, and Vizient Collaborate to Improve Supply Chain for Pediatric Drugs

CalAmp's new sensor for cold-chain applications provides visibility for shipping vaccines.

CalAmp Launches End-To-End Supply Chain Visibility Solution for Cold Chain

The availability of materials is a critical factor when it comes to vaccine capacity.

Supply Chain Challenges Creating Hurdles to COVID-19 Vaccine Production

Growth in cell and gene therapies puts pressure on the raw materials supply chain.

Materials Sourcing: Precautions and Improvements for Cell and Gene Therapies 

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Auditing distribution suppliers provides understanding and documentation of the services performed. 

Auditing for Good Distribution Practices

 Washington Editor, jillwechsler7@gmail.com.

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health. 

COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of BioPharm International's Editorial Advisory Board.

Steven J. Lynn is executive vice-president, pharmaceuticals for Regulatory Compliance Associates, Inc.

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

Conducting Effective Audits During and Post Pandemic

The Altrui Foundation is a non-profit organization that serves as a center point between manufacturers of unused medications and the charitable organizations that seek them.

New Jersey Students Launch Foundation to Transfer Unused Medications to Communities in Need

Jennifer Markarian is manufacturing editor of BioPharm International.

Podcasts

BioPharm International interviewed Cloudleaf about trends in tracking vaccines through the supply chain.

Supply Chain/Logistics