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Siegfried Schmitt, PhD, is principal consultant withÂ PAREXEL, Siegfried.Schmitt@parexel.com.
Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.
Q. The current travel restrictions have an effect on how we can perform supplier audits. Most audits are now virtual audits. Some work well, others not so well. How can we achieve more consistency?
A. For most companies, virtual audits (i.e., audits where contact is made via electronic means, such as video conferencing) are something new. This means that the participants do not yet have established protocols for the execution of such audits, nor is there a standardized technology platform available or agreed to. Thus, it comes as no surprise that auditors’ and auditees’ experiences are rather variable.
This fact has been noted, and industry associations (e.g., the Parenteral Drug Association) have established special interest groups to address this very problem. The virtual audit issues are multi-faceted and raise important questions.
The fact that a company may perform audits of a supplier is documented in quality technical agreements (QTAs). Typically, a QTA states that an audit may be performed over a set number of days in a set interval, involving a maximum number of auditors. That amount of information proved generally sufficient as documentation would be available and reviewed on site. Interaction would be with personnel present on site. There would be no time difference, and confidentiality can easily be achieved by a variety of means. Technology would not be an issue as everything would be present on site. If required, translators could be present. One would be able to talk to several persons within the same room and look at a number of documents simultaneously.
That was the past. Now much of the audit process is no longer a given, and it is therefore prudent and necessary to update the QTA. The section on audits should be expanded to include virtual audits and in that context address many, if not all, of the issues mentioned above. It may prove valuable to have a standard checklist (playbook) available that can be shared with the auditees. Updating the QTA in this way will make it clear to all involved parties what can be expected during an audit and what the limitations may be.
This definitely is the way forward for more consistency in your supplier audits and the time to do so is now.
Vol. 34, No. 1
Pages: 50, 49
When referring to this article, please cite it as S. Schmitt, "Now is the Time to Update the Quality Technical Agreement," BioPharm International 34 (1) 2021.