Overcoming the Remote Audit Challenge for Qualified Persons
Sharp Clinical Services received a request from US based Staidson Biopharma Inc to help the company commence clinical trials for a potential COVID-19 treatment in the European Union during the COVID-19 2020 pandemic.
Staidson is an early stage therapeutic drug discovery company that focusses on antibody and protein drug discovery and development. The company rapidly developed a potential treatment for COVID-19 and had conducted Phase I & II clinical trials in China with very promising results. Given the escalating pandemic situation in Europe, the company needed support to continue phase II & III clinical trials of their drug in the EU.
Speed was of the essence with the next stage of the trial, given that COVID-19 was proving to be a highly infectious disease with no known treatment or vaccine. Staidson faced multiple, complex challenges with bringing the trial to the EU:
- The facility in Beijing that was manufacturing and testing the API and the drug product had no regulatory or audit history outside of China, making this trial technically complex for the certifying Qualified Person.
- The drug treatment was a sterile product which added complexity and risk.
- The Beijing facility would be required to comply with EU GMP but China was in lockdown, as was Europe, and the conventional route of determining EU-GMP equivalence was not possible.
- The lack of regulatory history meant that this scenario fell outside of EMEA regulatory guideline criteria for remote auditing.
The Sharp Solution
The Sharp team immediately outlined a solution to address the regulatory challenges associated with the trial.
Sharp investigated the most current national COVID-19 guidelines and flexibilities for each of the EU countries that were to be included in the trial, in addition to general EMEA guidelines. The Sharp team then gave guidance to the client and their manufacturing team in China, as to the relevant regulations, what was allowable, where there were challenges associated with the requirements and how these might be mitigated.
Sharp also had to immediately develop a remote audit strategy, using various technologies to maximise the probability of acceptance by the regulatory authorities. This solution involved ensuring alignment and agreement between all parties to the audit.
Technology became a large part of the virtual audit solution, with the aim being to reproduce, as far as possible, a conventional audit while adhering to all regulatory requirements and guidance for remote audits.
All of the relevant audit documentation, photographic and video evidence – which included a real-time facility tour – were managed through a share drive.
An in-depth product-focused GMP pre- audit questionnaire was designed and completed. Three interactive teleconference question and answer sessions were hosted, covering:
- All of the relevant audit documentation, photographic and video evidence – which included a real-time facility tour – were managed through a share drive.
- An in-depth product-focused GMP pre- audit questionnaire was designed and completed.
- Three interactive teleconference question and answer sessions were hosted, covering:
- Quality systems
- Warehouse and manufacturing
- Analytical and micro laboratories.
“When we began we were deeply concerned how the GMP audit could be conducted during the COVID-19 pandemic and, with all the borders closed, how this EU GMP validation may negatively impact our COVID-19 therapeutic clinical trials progress.
Sharp Clinical provided an effective solution for the GMP inspection. Their Qualified Person performed the remote audit, reviewed all SOP and documents, conducted remote meetings, and completed live video inspection of all critical manufacturing processes.
We received the GMP certificate within one month, and finally we could move forward with the clinical trial in European on time. The later medicine logistics also ran smoothly, including QP release and medicine shipping to the study sites.
We were very satisfied with the professional services provided by Sharp Clinical”.
Staidson Biopharma Inc.
The Positive Outcome
The entire audit process was completed in less than three weeks. A QP third party declaration was generated within 2 days of audit closure. The QP declaration supported by a comprehensive memorandum detailing exactly how the QP was able to assure EU GMP equivalence was submitted to the competent regulatory bodies and accepted.
“The success of the partnership was built on open communications, the timely flow and review of information together along with the on-going flexibility and energy of all staff who were prepared to go above and beyond to ensure the audit was a success.”
Steve Girdlestone Head of Regulatory Services. Site QP and RP
Sharp Clinical Services