BioPharm International - May 2021

BioPharm - Partnerships for Outsourcing - May 2021

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26 BioPharm International eBook May 2021 Maz enko a lso emphasiz ed t hat remote auditors work most efficiently when they have access to data and documentation ahead of the remote audit. This way, auditors can review the information and decide on the most effective approach and scope of the remote audit. Marcus Massingham, senior director of quality systems at GSK added that digitizing physical documents for remote reviewing may add an extra, potentially time-con- suming step for some auditees. "We've found that communicating as far in advance as possible helps auditees plan for how to get the information into a format suitable for remote viewing," he said in the panel discussion. Just as auditors need more time upfront to review data and records, auditees will also need time to gather any additional information requested during the audit and organize appro- priate interviews, experts emphasized. Breaking down remote audits into dis- crete topics or segments and sched- uling extra time per topic, as well as breaks in advance, will help ever y- thing run more smoothly. Another point that experts on the panel emphasized was the need for audit participants to have training and hands-on experience from practicing with new technolog y such as video conferencing and collaboration solu- tions before the audit begins. They rec- ommended setting up practice sessions during which technology issues can be ironed out and participants can become more comfortable communicating with each other in a new medium. T he ef f ic ac y a nd ef f ic ienc y of remote aud it ing rel ies, to a g reat extent, on the ability to collect doc- u ments a nd data a nd sha re t hem securely with auditors. Q u a l it y m a n a g e m e nt s y s t e m s (QMS) built in the cloud provide a centralized location for key information and can streamline the organizing and sharing of quality data for any audit format. A cloud-based QMS can serve as a single source for quality documents and data, accelerating audit readiness and facilitating secure, controlled doc- ument sharing. Such a system should enable the organization to access infor- mation on a specific need or use case, making it easier to maintain and locate information while providing security, privacy, and confidentiality. With the needed technolog y and planning in place, remote auditing can offer some distinct advantages, including reducing or eliminating travel costs or lost time due to travel, greater productivit y and eff iciency, reduced risk of business disruption, and greater scheduling f lexibility for audits in the same time zone. For this reason, industry experts believe that remote audits will continue along with onsite visits once travel restrictions are lifted and onsite work is permitted. Massingham agreed that the industry will explore more hybrid approaches in the future. "I see the opportunity for more planning and prework to hap- pen off line, which will shorten the time needed for an onsite audit," he said in the panel discussion. Taking a hybrid approach can help the indus- tr y ma ximize eff iciency, streamline processes, optimize costs, and reduce the impact on onsite operations. The investments made now in conducting remote audits will continue to pay off, even when travel restrictions are lifted in the future. REFERENCES 1. FDA, Guidance for Industry, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry, (FDA, April 2021). 2. FDA News, "Increasing the Speed and Accuracy of Remote Audits With Modern Cloud QMS,", Dec. 17, 2020. BP Partnerships for Outsourcing Quality/Regulations Efforts to return to a more consistent and timely field in- spection program will take considerable time, as FDA ex- pects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel im- posed by the COVID-19 pandemic. With a huge backlog built up since March 2020, it's not clear when the agency's inspection program for drugs and medical products will fully recover. These challenges are acknowledged in the recently issued report "Resiliency Roadmap for FDA In- spectional Oversight," which details how the pandemic has delayed all but the most important "mission critical" and high-priority inspections this past year, leaving thou- sands of site visits needed in the coming months and years. The Roadmap reports that FDA was able to carry out approximately 1600 mission-critical and high-priority inspections for all regulated products from March 2020 to March 2021, far short of the more than 20,000 inspections normally conducted each year for food, tobacco, and medical products. About half of all the completed inspections (741) involve drugs and medical products. One result is that 68 of more than 13,500 applications for new medical products had approvals delayed largely due to the agency's inability to conduct inspections. The prospects for catching up are dim because the agency must address all those site visits missed this past year, while striving to deal with continued growth in its oversight responsibilities. FDA's best-case scenario calculates that it might be able to conduct 1600 domestic inspections this year—about half of the to-do list. —Jill Wechsler FDA faces massive inspection backlog

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