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Technology advances and pandemic environment drive increased use of automation and digital tools.
The sudden, compulsory move to remote work during the COVID-19 pandemic pushed many into greater use of a wide range of digital tools, including companies in the slow-to-change, highly regulated pharmaceutical manufacturing industry. In addition, continuing advances in connectivity and the availability of increasingly user-friendly technology reduced barriers to implementation. As a result, more companies are successfully using digitalization tools.
Digital tools that have been proving their worth in the past year include augmented reality (AR) and virtual reality (VR) systems for activities such as training, collaborative engineering design sessions, and factory acceptance testing of new equipment.
“During facility design, it’s been really helpful to use tools such as virtual reality and 3D modeling so all parties can review a design together in a collaborative manner, yet remotely,” notes Yvonne Duckworth, automation engineer at CRB. “As another example, we had a client who had a skid at a vendor site but couldn’t travel there to perform factory acceptance testing due to travel restrictions. We were able to provide them with the augmented reality technology to conduct testing remotely, which was very effective. It’s a great way to accommodate travel restrictions and still do thorough acceptance testing.”
In addition to using these types of tools, pharma manufacturing companies in the past five years have been moving toward a greater level of digital maturity, from manufacturing facilities that have “islands of automation” to connected plants with high levels of automation and beyond. “The level of connectivity we have now is allowing plants to look at concepts such as predictive analytics,” says Duckworth.
Companies are also employing digital tools to conduct audits of their suppliers or contract partners remotely, due to travel restrictions. Although many had to learn as they went and address problems as they arose, their experience has led to development of some best practices for these new methods. By employing best practices and available technologies, remote audits can be effective, says Peter Miller, principal partner at Dynamic Compliance Solutions.
The Parenteral Drug Association (PDA) formed a 27-member, international Remote Audits and Inspections Task Force that seeks to help members prepare for and perform remote inspections and audits (1). The task force held a workshop in early April and plans to publish “Points to Consider” documents.
In April 2021, FDA published a guidance for industry that explains how FDA may use interactive and virtual tools, during the ongoing COVID-19 public health emergency, for what the agency is calling remote interactive evaluations of facilities (2). Although these are not official FDA inspections, the agency says it will consider many of its usual inspections as possible candidates for remote interactive evaluations (3). A report released by FDA on May 5, 2021 provided an overview of inspections and evaluations using alternative tools conducted during the COVID-19 pandemic in 2020 and 2021, and outlined plans for moving forward (4). FDA said it plans a multi-year modernization effort to its regulatory oversight role that will support innovation, including remote approaches (5).
The editors of Pharmaceutical Technology and BioPharm International will be hosting interviews with pharmaceutical industry experts in digitalization in an online Technology Forum on May 25, 2021: Bridging the Digital Divide to Advance Bio/Pharma Manufacturing and Quality. Speakers will include Peter Miller and representatives from Merck to share best practices and experiences in remote audits; Yvonne Duckworth to discuss trends and best practices in digital tools for facility design and operation; experts from Stress Engineering to discuss simulation and digital twins; and consultants from McKinsey to provide another view of digitalization in pharma manufacturing. Click here for free registration.
1. PDA, “Remote Audits and Inspections May Be Here to Stay: PDA’s Task Force Aims to Help,” Press Release, Apr. 27, 2021.
3. FDA, “FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19,” Press Release, Apr. 14, 2021.
4. FDA, Resiliency Roadmap for FDA Inspectional Oversight (May 2021).
5. FDA, “Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations,” Press Release, May 5, 2021.