COVID-19

  1. Biopharma Answers Supply-Chain Questions Raised By COVID-19 3/26/2020

    In terms of increasing transparency regarding the location of production, Novartis, Regeneron, GeoVac, and Gilead are positive examples for Outsourced Pharma readers.

  2. COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain 3/26/2020

    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.

  3. Remote Auditing Best Practices For GMP Compliance 3/25/2020

    Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

  4. 3 Questions Of Risk And Communication In A Time Of Coronavirus 3/20/2020

    Communication with your service providers may turn out most important in getting through immediate coronavirus-induced supply-chain challenges. Outsourcing may have got you into this situation; now it may be the only thing that can get you out. 

  5. Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time) 3/20/2020

    Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.

  6. Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits 3/19/2020

     

    While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.

     

  7. Sign It, President Trump; Don't Go There, President Xi 3/17/2020

    If drugs are discovered as purposefully held up by China to create a supply issue in the U.S., would you ever again employ a China-based CMO? Who would have thought Outsourced Pharma readers would be front and center in presidential politics? But you are.

  8. Don't Spread The Wrong Message: COVID-19 And Respect For CMOs 3/13/2020

    The first was to be a celebration for safely, reliably, and productively keeping drug development and manufacturing supply chains running. The second is a threat to shut those supply chains down. But here’s a second irony: This new coronavirus may have provided us an opportunity of sorts. 

  9. COVID-19 No-Fly Zone: A Year And Counting For Biopharma Supply Chains 3/4/2020

    “Right now, the coronavirus situation is more about transportation than manufacture,” says one biopharma executive with a global supply chain. “If this continues for more than a year, then I think it'll be getting products manufactured that will really be in play.”

  10. Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk? 3/4/2020

    In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners.