Transporting large quantities of COVID-19 vaccines pose challenges.

Tracking the Cold Chain

Cleaning’s low-tech image is evolving to science-based limits and statistical approaches. 

Cleaning Validation Embraces Science

Planning and the proper use of technology facilitate effective remote auditing.

Conducting Effective Audits 

Topic

Articles

The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.

Clinical Data on Moderna COVID-19 Vaccine Published

The agency is working to identify and obstruct scammers looking to profit from the pandemic.

FDA Protects Consumers Against COVID-19 Scams

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).

Rolling Review of Sputnik V COVID-19 Vaccine Begins in Europe

The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.

FDA Publishes Guidance on Changes to COVID-19 Container Closure Systems

Garima Thakur is a graduate student in the Department of Chemical Engineering at the Indian Institute of Technology New Delhi.

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of 

l's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

The need for real-time monitoring and control has spurred the development of new analytical tools.

Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing

Shannon Parisotto, MBA, is the corporate senior vice president of Charles River Laboratories.

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.  

Toxicology: Ensuring Drugs are Safe for People

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

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

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA Gives Guidance on COVID-19 Variants

FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.

Quality/GMPs

Tracking the Cold Chain

Cleaning Validation Embraces Science

Conducting Effective Audits