Manufacturing

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

Articles

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

Auditing for Good Distribution Practices

Jill Wechsler is Pharmaceutical Technology's 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.

Trends in Vaccine Tracking

Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.

Now is the Time to Update the Quality Technical Agreement

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

Helena Offers Polymer Solution to Global Cold Chain Issues for COVID-19 Vaccines, Biologics, and Therapeutics

The company will expand its clinical supply chain services by establishing two new facilities in Rheinfelden and Weil am Rhein, Germany.

Thermo Fisher to Expand its European Clinical Supply Chain Services

A longer-than-expected scale up of raw materials forces Pfizer to cut 2020 vaccine production in half.

Raw Material Delays Cut Pfizer Vaccine Production

The agency, in response to an executive order, published a list of essential medicines, medical countermeasures, and critical inputs that should be available at all times in an adequate amount to serve patient needs.

Supply Chain/Logistics