There is no denying that the current COVID-19 pandemic has forced companies to change the way they are doing business while protecting their employees and upholding their social responsibility to the community and partners. A significant number of drug and device sponsors, marketing authorization holders, and manufacturers are still in operation and continue to fill the supply chain with their critically needed products. However, it is still necessary for each organization to ensure that their suppliers continue to provide services and materials that are fit for purpose and in compliance with quality expectations and that GxP audits are continued to verify that organizations comply with processes and guidelines. How does a company continue to qualify/re-qualify their critical suppliers and vendors while complying with “stay-at-home” mandates and social distancing requirements that prevent them from performing on-site audits?
Health authorities have started to provide guidelines, especially for clinical trials. For example, the FDA, as part of the Medical Device Single Audit Program (MDSAP), has provided some guidance for performance of virtual/remote auditing (Document No. MDSAP AU P0036.001, Effective 13 Jan 2020) which is of course directly applicable to a Medical Device Audit, but the concepts are also very adaptable to Pharmaceutical/ biologic audits of API facilities, CMO’s, Supplier, and Vendor Audits.
- Preparation for a virtual/remote audit is key to a successful outcome. Request information from the auditee to be submitted prior to the start of the remote audit to fully prepare the auditor. This includes quality manuals, SOPs, org charts, etc.
- Ensure that data privacy requirements (HIPAA, GDPR) are met in accordance with audit processes.
- Gain understanding from the auditee on how records will be “pulled” and shared. It is understood that confidentiality and controlled distribution of documents is a concern for the audited firm, so file sharing with read-only access is important. There are numerous solutions, such as sharing documents electronically via Screen Share or by a file sharing system such as Box.com or SharePoint.
- Document sharing must comply with applicable global and local data privacy regulations. In case legislation prevents sharing of some essential data outside the auditee site, the scope of the audit can be adapted on a risk-based analysis to enable compliant business continuity and, if needed, complimentary evaluations can be scheduled to finalize the quality assurance assessment.
- Ensure at least one or two auditee personnel are dedicated to supporting the audit over the designated period.
- Ensure the technology for the remote audit is agreed upon and tested. WebEx and Facetime are examples of available technology for tours and other options for video conferencing.
- Ensure web meeting invitations are sent with ample time for each party to plan conferencing and conference room space.
- Confirm the appropriate personnel are available and scheduled for the audit.
- Request a virtual tour be set up for a facility tour or detailed facility presentation by the auditee.
- Audit Plans and Agendas can be set up as normal.
- Time normally scheduled for a facility tour should be used to view an online virtual tour or presentation provided by the auditee in cases where a facility tour is mandatory. A risk-based assessment should also be applied to define the need of this facilities tour and/or which areas are essential to be covered if a complete tour is not feasible.
Performing the Audit:
- Conduct the audit as closely as possible to an onsite audit.
- Audits can be split in two or more sections with intervals of a big enough duration for auditee to collect and upload documents requested during the audit in the pre-defined shared drive.
- Hold opening meetings with appropriate personnel using the video conferencing tool agreed upon.
- Request a virtual tour of the facility or that a facility overview presentation be provided with pictures, facilities plant and process flow (if applicable), following the opening meeting.
- If many of the documents and records are made available ahead of time by email or via a website service such as Box.com, then the auditor can proceed with document review.
- Questions and requests can be made via chat, email, phone, or online web conferencing.
- If the auditee does not make the documents available for the auditors’ review, then documents and records will need to be shown via the video conferencing tool being utilized.
Closing: The closing meeting should be held as normal but via the video conferencing tool selected. Ensure that this meeting has been planned and scheduled ahead of time with the proper invitees.
There is no doubt that performing an audit on-site has its advantages and allows the auditor to examine processes in real-time, conduct a physical tour of the facility, and observe visual cues and non-verbal communication with the audited firm. However, the COVID-19 crisis has forced companies to adapt and utilize other solutions. A virtual/remote audit is an excellent solution to allow for business continuity and ensures that critical suppliers and vendors continue to function within a state of compliance as an extension of your firm.
ProPharma Group can help you establish and maintain a common-sense, risk-based supplier management program while utilizing tools such as virtual/remote auditing to fulfill your business continuity requirements and ensure that studies can continue while protecting participants from being infected.
Your Business has Complex Challenges. ProPharma Group has Exceptional Solutions.
We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.
Interested in gaining an industry edge? Let us help you stay up to date.
Gain an Industry Edge With Expertise From ProPharma Group
Get the latest insights and top tips from our experts, delivered right to your inbox.
Have a complex challenge?