FDA’s Guidance for Remote Audits: Good Intentions, Bad Perceptions
(Thursday, April 15, 2021) Yesterday, 14 April 2021, FDA released a new Guidance Document on remote audits, which could have been more appropriate in April of last year than now. While the GAO and other independent groups have been panning FDA for not conducting on-site audits, this guidance seems to push back hard by proposing that remote audits are as good as on-site audits. And the timing of the release is off. At a time when there is talk about the pandemic coming to an end, and normal activities resuming in the next few months, this Guidance Document creates an opposite perception, that FDA is preparing for the longer pandemic. A Guidance Document takes a lot of resources to be created; there is an elaborate process involves several FDA experts to craft and draft a Guidance Document for public release. Most Guidance Documents live for years and some even for decades. Although Guidance Documents claim to have no legal force, they represent an official verdict from the FDA about its policies and beliefs and weigh heavily on FDA’s decisions. This Guidance Document confirms what is generally known to the industry since FDA has been conducting remote audits for an entire year as evident from the various Warning Letters issued last year. The Document describes the practices followed for remote audit such as remote auditing dos and don’ts, pre-audit documentation review, virtual tours of the manufacturing facilities, remote interviews, and potential outcomes. Similar documents from FDA were released at more appropriate times at the beginning for the pandemic in March and August last year. So, rather than educating the industry, the primary purpose of this document seems to be to push back to the critics of FDA’s remote audits. Although the document contains disclaimers that these practices are limited to the pandemic, it creates an impression of a long-term process; that FDA expects the pandemic is continue for a significant time and hence is formalizing its pandemic related processes now, contrary to the general perception is that the pandemic is coming to an end and that activities would get back to some “normalization” by this summer. It could reflect what FDA believes, that the remote audits are probably going to be more common going forward rather than a pandemic related necessity. Why else would FDA release this Guidance Document now! |
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AUTHOR
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Email: mkumar@fdamap.com
Linkedin: Mukesh Kumar, PhD, RAC
Instagram: mukeshkumarrac
Twitter: @FDA_MAP
Youtube: MukeshKumarFDAMap
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Email: mkumar@fdamap.com
Linkedin: Mukesh Kumar, PhD, RAC
Instagram: mukeshkumarrac
Twitter: @FDA_MAP
Youtube: MukeshKumarFDAMap