The COVID-19 pandemic has created an unprecedented challenge for pharmaceutical companies thrusting them into an unforeseen scenario where they must manage competing priorities for the protection of both their patients and their personnel. As companies strive to manage and maintain their supply chains to minimise patient impact, they are required to restrict travel, follow government directives limiting social contact and ensure they prevent exposure of their personnel to infection with COVID-19.
In the pharmaceutical industry there is an emphasis on robust Supplier Quality Management. Proactive auditing plays a key role in ensuring suppliers and contracted organisations continue to supply goods and services that are fit for use, meet the required GxP standard and maintain the terms of quality and technical agreements. In the current situation that we find ourselves in, how can these activities be maintained whilst managing the real risk of COVID-19 transmission? For many companies, postponement of audits for an indefinite period of time is not a viable option. Effective oversight of suppliers must continue in addition to the resource constraints that will arise if all audits are postponed and then require completion in a short timeframe after all COVID-19 restrictions are lifted.
Luckily, we live in the technology age and have a myriad of technologies at our disposal that can assist us in fulfilling our obligation as an industry to maintain quality oversight of all our suppliers and service providers. Prior to COVID-19 and in order to reduce the requirement for extensive travel but still provide an environment where systems and procedures can be suitably challenged in a manner that is equivalent to a traditional site based audit, PharmaLex had commenced the development of alternative strategies for auditing including desk-based and virtual auditing..
As COVID-19 has changed the landscape in terms of how we must engage with each other, whilst also continuing to provide our patients with the therapies they depend on, PharmaLex can assist clients with virtual audits that will keep the audit program on track. The PharmaLex virtual auditing model includes the following elements;
- Risk Assessment –
- Facilitate or perform a Risk Assessment to assess the risk to the supplier management program if the audit is delayed or postponed.
- If the risk of postponement is high, facilitate assessment of virtual audit feasibility.
- Preparation for the Audit –
- Agree the Audit Agenda with the client and auditee with particular emphasis on how the audit will be performed.
- Identify the appropriate technology for opening and closing meetings, sharing documents and discussing topics with SMEs.
- Identify the information that the auditors will require in advance for remote review
- Develop a questionnaire for provision to the auditee to capture pertinent information in one location that will help set the scene for the audit e.g. organisational structure, certifications and facility description.
- Virtual Audit
- Opening meeting through video conferencing.
- Auditing of the Quality Management System using documents that have been provided in the shared document repository and through conversations with SMEs over video conferencing platforms selected by the auditee or client.
- Virtual tour of the facility, if required, using cameras, virtual reality or alternative suitable methods.
- Feedback at the end of each day and closing meeting through video conferencing with all relevant stakeholders
- Reporting and CAPA
- PharmaLex will provide a written report detailing the observations made, classified according to risk and suggested remediation actions for each observation
- PharmaLex can support with the implementation of Audit CAPAs
- If required and recommended following the virtual audit, PharmaLex can support a follow up, on-site visit to the auditee when COVID-19 restrictions are lifted.
PharmaLex can support our clients with any type of audit and have successfully used our virtual auditing model for audits of suppliers, contract manufacturing/laboratory organisations and mock regulatory inspection audits. We can also support internal self-inspection audits for those organisations who may require additional support at this challenging time.
If you require any assistance with keeping your audit program on track, please do not hesitate to contact us at contact@pharmalex.com
