Harnessing the power of virtual audits to keep regulatory compliance front and center in 2020

Author: Mary Todas, Pfizer CentreOne Technical Services Lead

May 2021

It’s been over 12 months since the COVID-19 pandemic led to changes in the way businesses and the economy operate. Lockdowns and social distancing measures meant that businesses, including those in the pharmaceutical industry, needed to rethink working patterns and day-to-day operations to safeguard team members.

Pfizer was no different – we took steps to limit access to our sites to key personnel, supported team members who could work from home, and adapted our facilities to maintain the wellbeing of the people remaining on site.

This wasn’t the only area requiring a rethink, however. The pandemic made us reconsider the way we at Pfizer CentreOne manage our relationships with customers as well.

A key part of the work we do for our customers is ensuring consistent high standards of quality and regulatory compliance. To maintain supplier qualification, regular audits are conducted by our customers.

Due to the various quarantine measures that had been implemented at sites to comply with local, state, and national restrictions, in-person audits could not be conducted. Therefore, it was vital to find innovative solutions to demonstrate our compliance commitment to our customers. Our active pharmaceutical ingredient (API) manufacturing facility in Kalamazoo, MI, came up with an innovative solution.

The virtual world holds the key

As a substitute for the on-site customer audit experience, our Kalamazoo team harnessed the power of advanced digital technology to develop a virtual audit program.

In connection with our new virtual audit, we ask our auditors to select the subjects they want to cover during their audit via a questionnaire, including:

  • Master batch records
  • Standard Operating Procedures (SOPs)
  • Training records
  • Annual product reviews

Once we understand which topics customers want to audit, we load the relevant records into a shared document site for the relevant auditors to access for a limited time. This site also offers an online introductory session offering information about how the virtual audit works to support auditors in navigating the process.

Virtual meetings are then set up with our subject matter experts (SMEs) in order for the customer to discuss the documents. Once these meeting have taken place, a final virtual concluding session can be held, if needed. The customer audit report is issued as usual, and response to any observations is issued by the site and sent with the customer.

Meeting customers’ needs

Our Kalamazoo team completed the first audits under this exciting new virtual system in December 2020. Six customers, all of whom were enthusiastic about this new virtual option, participated.

For our team, the major challenge was providing access to SMEs for customers as and when they needed it. A traditional in-person audit typically takes one day, with all SME meetings taking place at the same time. The virtual audit can require up to one week in order to allow the necessary contact time between customers and SMEs.

To help overcome challenges, our Technical Development Manager worked with our Kalamazoo quality assurance compliance team to devise an appropriate structure for the virtual audit. Once they created an effective virtual document storage system, the team collaborated with customers to ensure they could access everything they needed. During the first audit, the team attended every meeting in order to address customer queries and identify areas where the process could be improved in future.

A resounding success

Our first virtual audit was a great success, with customers pleased to be offered a new way to audit our facility despite the challenges of the pandemic. We are using the feedback from auditors about the virtual process to plan the next round of audits to make them even more convenient and informative for customers.

Once the pandemic restrictions ease, we foresee the return of in-person site audits. However, our new and effective virtual audit program will continue to play a vital role in providing customers who are unable to visit our sites in person, for whatever reason, the opportunity to carry out those all-important audits.

We’re proud of the ingenuity of our Kalamazoo team. We can’t wait to see what they do next to enhance the experience for Pfizer CentreOne customers.

Click here to find out more about the regulatory support offered by Pfizer CentreOne.