Now is the Time to Update the Quality Technical Agreement

January 1, 2021
Siegfried Schmitt

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

BioPharm International, BioPharm International-01-01-2021, Volume 34, Issue 01
Pages: 50,49

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.

  • Technology: Which video sharing platform should be used? What bandwidth is required? Can several parallel video streams be set up?
  • Methodology: Will a virtual tour of the facility be provided? Will documents be shared prior and after the audit? Will documents be reviewed online during the audit, or offline outside of audit hours?
  • Culture and language: How can translation be accommodated remotely? What is the official language? Some countries have more than one official language, or a foreign language may be selected as the agreed language for the audit.
  • Timing and time zones: How can different time zones be accommodated? Does the agenda clearly define the time zone (some countries have more than one time zone)? When and for how long will breaks be planned?
  • Staff availability: Do staff members have to isolate at home, preventing them to come to the site? Are staff, such as operators in the plant, available for interview? Are staff comfortable being interviewed via video link?
  • Privacy, security, and confidentiality: Could video footage impinge on data privacy legislation? Who is allowed to listen in to the audit? Do all attendees, even those not visible on screen have to be disclosed? Will the audit
    be recorded?
  • Documentation sharing and availability: Can documents be scanned (e.g., logbooks, executed protocols)? Will documents be available for download to the auditors, or will they only be presented on screen?

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.

Article Details

BioPharm International
Vol. 34, No. 1
January 2021
Pages: 50, 49

Citation

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.

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