COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.

During a recent Halloran Virtual Town Hall meeting, a panel of experts to share what they are seeing in terms of regulatory activity, as some cases are receiving expedited feedback, while others are experiencing delays in reviews and receipt of commentary from the FDA. This article presents some key insights from the panel’s experience conducting regulatory activities during the pandemic.

During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.

Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.

This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.

While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.

We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.

To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.

Do you like fighting quality fires? Do you enjoy generating meaningless metric reports that no one acts upon? Do you get the most from your quality risk management (QRM) program? This article provides three practical steps for integrating QRM into your quality system to ensure your organization stays on course.

Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, but now there is a public health imperative, with a large percentage of people working from home. If you are facilitating a risk assessment, a root cause investigation, or something similar, you may need to do a “virtual facilitation” with team members and subject matter experts who are scattered around the world.