Since the start of the pandemic, every industry has searched for new ways to leverage technology to complete time-sensitive critical tasks remotely. This is certainly true in the biopharmaceutical sector, in which on-site good manufacturing practice (GMP), good laboratory practice (GLP) and good clinical practice (GCP) audits (collectively GxP), required to manufacture and market medicinal drug products for human use, have become virtual audits.
While a technical GxP virtual audit is not a substitute for one conducted on-site, they are a necessary response to the difficulties imposed by current travel restrictions and social-distancing directives. In the biopharmaceutical profession, audits are mandatory for drug substance and drug product manufacturers, analytical and clinical testing labs, and suppliers of critical raw materials. Due to the increased pressure on the pharmaceutical industry to find treatment of COVID-19 and the need to continue manufacturing currently marketed drug products and clinical trial products, we must carefully manage competing audit priorities. Fortunately, our profession had a strong infrastructure and tools for communication engagement with clients and service providers before COVID-19. These tools enabled auditors to quickly adapt while continuing to assure compliance with high quality standards and regulations in the medicinal drug manufacturing environment ensuring patient safety.
At BDO, we are working closely with our clients to ensure that our virtual audits are as thorough and accurate as our in-person audits. An effective virtual audit must be planned by outlining the steps associated with a conventional on-site audit and then determining how to achieve the same objectives and goals remotely. These steps vary from client to client. Activities that are difficult to execute virtually, such as a drug product manufacturing facility tour, are given special attention with a collaborative approach to developing effective and accurate workarounds. To tackle hard-to-adapt processes, the audit team must assess problems and consider a risk-based approach to determine the follow-up actions required after completing a virtual audit.
The following actions are crucial in ensuring that our virtual audits adhere to the same stringent requirements as our in-person practice.
Properly prepare and overcommunicate: Since virtual audits typically do not involve sustained face-to-face communication time, there is a risk of vital elements of an audit being lost in translation or not communicated via casual conversation. A virtual audit increases the need for significant and effective pre-audit communication and planning. Of particular note, activities performed during a virtual audit might require additional legal permission relative to what is typically required during an on-site audit, as documents are being shared virtually rather than reviewed on-site and video feeds are required for facility tours into confidential areas.
How can we replace the value of face-to-face communication, especially in situations where virtual audits are a novel concept? Training, communication, and collaboration. Auditors may require additional training. Manufacturers, suppliers and testing labs for medicinal drug products may require additional transparency and collaboration. All the more reason for overcommunication and thorough planning from the start!
Use time-tested technologies creatively: Video communication is critical in performing a virtual audit. This will serve as a tool for interviews with the scientific staff involved in the manufacturing and testing of the drug product, as well as a tool to perform a “live” inspection of the pharmaceutical facility.
As with every new technology utilized in audits, attention must be paid to risks. Fortunately, technologies like videoconferencing have already been adapted by the industry for the purposes of sharing information in a live setting. But in an audit scenario, video software must assure confidentiality and be protected from cyber-attacks. For confidential scientific document file transfers and other transmissions of sensitive material, encryption and other privacy protections must be in place.
While the virtual audit process is not equivalent to an on-site audit conducted by an experienced auditor, these technical workarounds will support the biopharmaceutical industry as we navigate the next year or more. After all, despite this challenging pandemic, our industry will move forward. Technology assist us in fulfilling our obligation as an industry to maintain quality oversight of all our suppliers and service providers to manufacture medicinal drug products that are safe and effective for human use.
(Adapted from Virtual Audits: A New Reality in the World of COVID-19 originally published in Bioprocess International)