Industry should improve the standards for detecting drug impurities.

Knowing Nitrosamine Risks

With many on-site visits on hold, FDA seeks alternatives

Inspections Remain Stalled

Using secondary reference standards poses scientific challenges.

The Value of Pharmacopeial Reference Standards

With the proper technology, remote auditing can be effective.

Conducting Effective Audits

Topic

Jennifer Markarian is manufacturing editor of BioPharm International.

Articles

Integrated, paperless data systems can improve efficiency and quality.

Digital Tools Enhance Raw Material Traceability

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 BioPharm International'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

EMA has recommended that Evrysdi be granted marketing authorization in the EU for the treatment of patients with certain types of SMA. 

EMA Recommends Oral Treatment for SMA

The EC has launched a structured dialogue aimed at gaining a better understanding of global medicines supply chains and to identify potential causes and drivers of vulnerabilities.

EC Launches Structured Dialogue to Address Medicines Supply Vulnerabilities

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA Documents Achievements and Plans for Future

Sean Milmo is a freelance writer based in Essex, UK.

The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.

Adapting Regulations Post-Brexit

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, says Siegfried Schmitt, vice president, Technical at Parexel.  

Auditing for Good Distribution Practices

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

EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.

EMA Commences Rolling Review of Regdanvimab

NICE has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with HCC.

Quality Systems

Knowing Nitrosamine Risks

Inspections Remain Stalled

The Value of Pharmacopeial Reference Standards

Conducting Effective Audits