Travel restrictions and social distancing due to COVID-19 have forced pharmaceutical companies to look for alternatives to keep supply chains safe and compliant, without the possibility to conduct onsite supplier audits. Therefore, as people started to explore possibilities that modern digital technologies allow, the discussion of remote / video audits has gained new momentum. Not only do these remote audits offer the possibility to improve audit efficiency and reduce costs, but they can also contribute to more carbon-efficient operations, thus helping the planet. But moreover, a combination of frequent remote audits and occasional onsite inspections can even improve current auditing effects.
The application of a marketing authorization must be accompanied by a-
“written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits.”Article 8 of EU-Directive 2001/83/EC
Other critical suppliers or service providers might be entailed to regular onsite audits according to internal procedures. Also, guidance for QP declaration and batch release laid down in Annex 16 of the EU-GMP guideline includes confirming onsite audit performance in the declaration.
How can you integrate remote audits into the supplier qualification procedure to ensure compliance, safety, and adequate results?
EMA has published a Q&A document that provides some light on this alternative, at least for the time being. The aim of all these “opinions” is to keep protecting human health. Nevertheless, it is the Marketing Authorization Holders’ responsibility to carefully assess the risk to decide if it is appropriate to move to virtual audits. You can do it in parallel to or as a part of each company’s supplier management program.
When doing such an assessment, you should consider multiple factors such as:
- company profile and background (location, activities performed, size),
- regulatory oversight and certifications,
- inspection history,
- cross-contamination risk,
- recalls and complaints,
- nature of material or service,
- and product development stage.
The Challenges and the Benefits of Remote Audits
Even though you can confirm remote audits’ viability depending on the associated risks, their actual execution poses an interesting challenge for most companies. Therefore, based on our experience, doing onsite audits and our qualified auditors’ expertise and skills, we have developed an open and efficient method for executing remote audits. The method ensures that the efforts are always proportionate to the level of risk associated with the supplier or service provider.
A successful example of this strategy’s application was the audit to Transco Berlin Brandenburg GmbH (TBB). TBB is a carrier, freight forwarder, and logistics provider based in Germany, that we performed in May 2020. During the planning stage, we discussed the benefits and challenges of the remote audit broadly. On the one hand, this approach has more flexibility, reduced participation time, reduced cost, lower environmental impact, and increased efficiency.
On the other hand, doubts can arise about:
- information security and confidentiality,
- suitable work environment,
- quality of objective evidence,
- insufficient or unreliable technology,
- and personnel flexibility.
Preparations for a Positive Outcome of a Remote Audit
Despite the uncertainty, all interested parties’ collaborative efforts ended up in a detailed and comprehensive agenda, and TBB provided relevant documentation in advance to facilitate the execution of the remote audit.
During preparations, we agreed on periodic breaks in advance to allow the auditor and the auditee moments of refreshment, which we recommend to prevent the stress from a tightened posture and focus on the screens.
We also discussed with TBB the most suitable and secure video conferencing platform and file-sharing tool and did a dry run of the technology to confirm the audit objective was feasible and comfortable for everybody.
The Recommendations for Remote Audits
From the many platforms available, it is important to select the simplest video conferencing platform which guarantees the audit objective and security, as more complexity can lead to more problems. The availability of video connection between the audit participants helped keep the human connection during the audit, which progressed very smoothly. Additionally, we also highly recommended to think of having a backup or “Plan B” option.
In this case, TBB presented the documents using the screen sharing option as they were available in electronic format. TBB provided a clear explanation of all the processes, and the representative showed examples virtually.
The facilities tour was not applicable for this auditee (reinforcing the applicability of the remote audit approach); however, you can use:
– recordings of the facilities
– bespoke videos of how the operations work
– facilities layouts,
and so on to evaluate the compliance of the facilities in other cases. In such cases, keep in mind that you would need to perform a proof of accuracy.
The complex situation caused by the COVID-19 pandemic has forced companies in all sectors to adapt their processes and operations. Certainly, onsite audits at suppliers of the pharmaceutical industry are not the exception. Like Qualifyze, every company should develop a strategy for remote audits. An approach that will allow it to keep supply chains safe and compliant, even in times of restricted mobility.
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