The audit function of a pharmaceutical company is one cornerstone of an effective and efficient quality management system. There are several types of audits that comprise a robust auditing program including supplier audits, internal audits, and regulatory audits.
Each of these specific audits requires preparation to make sure the audit is productive and accomplishes its intended purpose, which, in the manufacturing world, is to ensure facilities are manufacturing fit-for-use products in full adherence (hopefully more) to current good manufacturing practice (CGMP) requirements.
Supplier audits are performed to confirm that the suppliers of raw materials, packaging, and labeling components, etc., are able to provide a continuous, uninterrupted supply of materials that are compliant with CGMPs.
Regulatory authorities perform inspections to determine if the manufacturing company is providing materials that comply to CGMPs. Internal audits are performed by the company as a self-assessment for the purpose of identifying areas/issues that might affect their compliance status.
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Pre-pandemic, preparing for a supplier or regulatory audit typically consisted of the regulatory inspector providing the facility being audited with an agenda. This listing would include areas to be toured and documents to review.
Areas to be toured will include incoming raw material area, quality control, chemistry and microbiology laboratories and manufacturing. Documents to be reviewed include the quality manual, list of standard operating procedures, open deviations, and corrective and preventive actions. Any additional supporting evidence the auditor chooses to review will help auditing authorities assess and decide the facility compliance status.
Performing external audits during a pandemic
The documentation that would have been reviewed on-site pre-pandemic is the same documentation that is needed for review during and post the COVID-19 pandemic. The documentation and supporting evidence review conducted pre-pandemic would most likely have occurred at the facility.
However, audits conducted during the pandemic require the documents and supporting evidence to be shared electronically to the auditor using secure electronic systems. This electronic exchange helps make time more efficient for both the auditor and the facility being audited. The documentation can be reviewed by the auditor, and questions can be communicated to the audit manager via email, conference calls or virtual technology.
While this may not be ideal, because it eliminates the in-person interaction, it is still an effective way to conduct an audit when there are conditions prohibiting face-to-face interaction.
Facility Audit Tour
Touring the facility is challenging when a virtual audit is conducted during a pandemic, but challenges can be overcome with some flexibility and ingenuity.
Live video feed could be streamed to the auditor while the company’s audit manager and/or subject matter experts are available. This can help answer questions that might arise during the live videoconference.
Audit Video Recording
Additionally, operations could be recorded, and that recording could be provided to the auditor. The understanding would include the audit manager being available to answer any questions upon the review of the video.
The recorded version of the tour is probably not the most ideal for two reasons. First, the auditor needs to see things in as real time as possible. However, it allows for the auditor to pause and go back to review a specific operation in more detail if warranted.
Internal audits during a pandemic
Preparing for an internal audit requires the same discipline as preparing for supplier and regulatory audits. During the COVID-19 pandemic, many companies reduced the number of employees allowed at the site. Many of the other quality personnel that conducted audits were allowed to work remotely.
Internal audits are part of management responsibilities and must continue to be performed, even during a pandemic. Conducting an internal audit is different from the other audit types, whether it is pre-, during, or post-pandemic. If designed and implemented appropriately, there is great value in the internal audit. It allows the company to find vulnerabilities in their systems and remediate before they are discovered by an external auditor.
Internal audits can provide valuable information that can be used to prevent issues before they become compliance concerns. If these issues can’t be completely remediated before an external audit, a plan to correct them can be established and take action to mitigate them.
Having corrective actions in place before others identify the issue may lessen the impact of the observation. The goal is to instill confidence that your quality system is under control. Most importantly, show there is a process in place for continuous improvement.
In addition, the internal audit can be used for training staff and communicating valuable information to the organization.
The ideal tone for an internal audit should be a collaborative team-oriented activity that is instructive, informative, open, honest, and inclusive. There are several factors that help contribute to establishing this tone, even during a pandemic.
One way to set the proper tone is to publish the audit schedule or agenda in advance. This makes sure the functional areas personnel are informed of the time schedule. During a pandemic, the agenda takes on another level of importance because it ensures the proper documents are ready to go. Teams should upload all data either before or during the audit. Prior planning precludes poor performance in this area.
The auditors should work with the functional area and talk with as many employees as possible to identify the issues of concern. Individuals who are responsible for performing the day-to-day activities often have the best insight. Questions would include what is currently working and what needs to be improved.
Excluding them from participating in the audit process might result in overlooking a serious issue. As a result, this could come up or inadvertently lead the auditor to think the site is hiding something. To be able to get the most valuable information about the potential compliance issues facing the organization, internal audits should not be judgmental or antagonistic.
Auditors should be direct and avoid asking questions designed to intentionally stump people. Another important behavior is the ability of the auditor to listen to the answers and refrain from judging. The exact same behavior defined for the auditor should also be the behavior displayed by the auditees.
Auditees should be direct and avoid deflecting or obfuscating answers. They should take the time to explain why they do things the way they do them. Answers should be proactive, point out things of concern and seek advice on how to remediate them. Both parties need to remember they are not enemies, rather they are the partners in improving the organization.
Conducting audits during the pandemic has presented a multitude of challenges. The pandemic has allowed the industry to creatively utilize technology-based applications to communicate and perform an effective audit.
The documentation and supporting evidence review can be conducted remotely, and confidentiality can be maintained. After reviewing the documentation and supporting evidence, the auditor can request interviews with various personnel. The interviews can then be scheduled via Zoom or online video conferencing.
With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing. The post-pandemic sweet spot will likely be balancing remote and in-person audits.
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