PDA Letter Article

New PDA Task Force Offers Resources for Industry

by Anil Sawant, PhD, Merck

It goes without saying that the COVID-19 epidemic has upended our industry. Shortages of critical medicines loom and there is also shortage of disinfectants and sanitizers along with personal protective equipment (PPE), e.g., masks and gowns. Of course, PPE is also needed to meet our GMP standards and associated Standard Operating Procedures (SOPs).

As chair of PDA’s new temporary COVID-19 task force, I am excited about this opportunity to help the pharma and biotech industries as they face the twin challenges of developing and manufacturing treatments and potential vaccines for the novel coronavirus while also working hard to ensure a stable supply of the sterile products used to treat other conditions. Naturally, social distancing requirements, absences and the need for enhancing cleaning and disinfection are some of the issues facing us.

Task force members Anthony Cundell, Dennis Guilfoyle, Thomas Kreil and I submitted a paper “Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the Covid-19 Pandemic,” for publication in the PDA JPST. It is currently available as an accepted article. This paper provides background information on the virus and its history, examines spread and controls in the context of GMP, analyzes the current state of the industry as far as preparedness and makes recommendations.

We also hosted a webinar on May 27 featuring three members of the task force, Thomas Kreil, Anthony Cundell and James Polarine. They touched on the makeup of the virus, supply chain challenges and cleaning and disinfection strategies. The task force also plans further webinars, so continue to check out the PDA events page.

The task force is also planning to draft a technical report and/or other best practice documents for industry.

This is a challenging time for the industry. At the same time, we can learn from it to prepare for other potential disruptive events. PDA will continue to support its members in the industry by providing comprehensive resources to ensure the stable supply of medicines.