Technology was key to continuing business as usual throughout the pandemic wherever possible. At Sharp this meant being creative and adaptable, pushing the potential of technology and exploring new ways of working so we could continue to support our clients.
We quickly identified that virtual auditing and online tours of our facilities would be essential for our clients to continue business as usual, as the lockdown prevented them from travelling and visiting sites. The virtual experience allowed Sharp to continue to support new clinical trials and launch commercial products with minimal disruption, with the added benefit of lowering the associated cost and time spent by clients on auditing.
Given the success of our virtual audits, for both Sharp and clients alike, it is very likely that they will continue to be offered and will become part of the ‘new normal’.
Barbara Ost, Sharp’s Divisional Vice President for Quality Compliance & Regulatory Affairs outlines Sharp’s approach to virtual audits and what they mean for our clients moving forward.
Flexibility: the ever-present foundation of innovation
Having the ability to respond and adapt our usual methodologies and pivot to a new way of working is always key for innovation and growth and this came into stark focus during the pandemic. From the onset of the worldwide lockdown, Sharp restricted access to its sites, travel was severely limited, and all non-essential employees were asked to work remotely – as was the case for most of our clients across the globe.
Pharma manufacturers and trial sponsors were still trying to get their jobs done and deliver critical medications to patients while meeting regulatory requirements. At Sharp we support approximately 60-70 client audits annually and each one takes several days of preparation and 2-3 days of ‘on-site’ time. Pausing or delaying audits for an unforeseeable length of time simply wasn’t an option as it would have meant delays to product launches and prevented continuing operations as normal.
To eliminate potential disruptions, we quickly developed a compliant virtual audit process for our clients using the expertise of our audit team and support from marketing, IT and operations departments to develop the content needed. When travel restrictions first began, many companies simply postponed this activity but as the pandemic refused to abate, most of our clients took the decision to undertake audits remotely.
Preparation is key
A typical in-person audit will see clients spend two days onsite observing processes and reviewing documentation. We send clients an audit packet, and typically they come back and tell us which processes they want to look at. Traditionally, audit schedules have been fairly intuitive, with clients wanting to observe processes and areas with limited notice.
The virtual audits we conduct typically last two days but, with a more structured schedule in place. More up-front preparation is required in order to use time as efficiently as possible. We capture videos and photos of critical processes they want to focus on in advance and prepare for viewing of documents, including SOPs and certifications, that can’t be shared outside of the Sharp facility. We also ensure other stakeholders from across the Sharp organization are on hand to discuss any technical information required.
The videos have been incredibly successful. We can run the video of our facility and/or equipment, stop at certain places and have conversations with clients about what is happening, just as we would if they were in the production suite.
Where auditors don’t know what they want to see in advance, which might be the case with new clients, we have a minimum of two Sharp auditors. One to facilitate the audit and the other operating in the background getting documents ready and tracking down subject matter experts in the facility to address questions.
The virtual tours have brought a shift toward heavier audit focus on documentation as opposed to the production floor. Auditors are spending a little more time on documentation because of the significant time they can save by conducting their tours by video. Audit teams no longer need to gown and physically walk through different areas of production on foot.
There are also some interesting cultural differences – EU auditors tend to spend more time on the production floor in suites, watching what’s going on. US auditors tend to follow a linear approach walking through a production process from the beginning, looking at the suites that are relevant to their process and not necessarily the entire facility. It’s vital to understand and accommodate nuances like this when preparing video content.
While the human cost of the COVID-19 pandemic is undeniably tragic and the associated lockdown restrictions are still very evident, it has catalysed some positive changes for the pharma sector. We hope that the adoption of virtual audits is continued beyond the eventual lifting of travel restrictions and face-to-face meetings. Audits are and will continue to be essential and conducting them remotely is a natural progression to the work we are doing. They reduce travel time and the associated expense, while still maintaining the necessary due diligence and required regulatory compliance, ensuring that our clients are providing safe and effective products to patients.
Partner with Sharp
The success of Sharp’s implementation of virtual audits was a result of the flexibility, expertise and energy of our team. It was also due to the trust and open communication we work to develop with each of our valued clients. More than anything, it demonstrates that Sharp is prepared to go above and beyond to ensure that our pharmaceutical and biotech clients get the support and service they need to deliver critical drugs to patients around the world.
About the author
Barbara Ost, Divisional Vice President for Quality Compliance & Regulatory Affairs at Sharp
Barbara joined Sharp in 2010 and is responsible for providing corporate direction for quality activities at all our sites worldwide. She conducts regulatory and Good Manufacturing Practice (GMP) assessments on new and ongoing projects, as well as providing direction for GMPs, validation and clinical activities.
Before joining Sharp, Barbara was Vice President of Quality Assurance for Bilcare Inc, Associate Director of Worldwide GMP Compliance for Merck & Co. and held several roles within Johnson & Johnson. She has a Bachelor of Science in Biology and has served on the boards of the Mid-West Clinical Supply Group and the Food, Drug and Cosmetic Division of the American Society of Quality.
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