Regulators discuss expectations and challenges in conducting virtual inspections

Regulatory NewsRegulatory News | 29 April 2021 |  By 

Regulators from the US Food and Drug Administration and the European Medicines Agency gave an update on desktop and virtual inspections and offered some advice on ensuring smoother audits at a 28 April webinar.
While there seemed to be acceptance among regulators that virtual and desktop inspections are a reality until the COVID-19 public health emergency is over, a larger group of health officials at the webinar said that onsite inspections are much better at uncovering violations of good manufacturing practices and are anxious to resume them.
Regulators from 11 agencies, representing the US, the UK, Spain, Germany and Russia, discussed their views on these challenges and opportunities for virtual inspections at the International Society for Pharmaceutical Engineering’s global pharmaceutical regulatory summit on 28 April.
Currently, unless critical and life-saving medicines are at stake, regulators cannot conduct most on-site inspections because of the current pandemic; they are grappling with how best to use these remote assessments to determine compliance with good manufacturing practices (GMPs).
Wide use of desktop assessments in the EU
Brendan Cuddy, the lead scientific officer for European Medicines Agency, said that since April 2020, EMA has performed 34 distance assessments. In the EU overall, authorities have conducted 202 distance assessments since the start of the pandemic up to 31 March 2021. Of these, 37 sites were located outside the EU while 165 sites were in the EU.
For the virtual audit to go smoothly, he said that the site must have “demonstrated ability” to facilitate and support the distance assessments, and have the necessary resources and information technology infrastructure, including having a robust meeting hosting platform. Companies must also be able to share documents and have live video capability as well as security measures in place to protect their data.
In addition, companies must also have interpreters available to the regulators, if necessary. There also must be strong management support and leadership for virtual inspections at the site.
How to prepare for desktop audit
Carmelo Rosa, the director of drug quality in FDA’s Center for Drug Evaluation and Research, was asked how to prepare for a desktop audit. He responded that “we are asking for the same information multiple times.”
This includes reports on out of specification results, validation reports, and information from previous inspections. He said that submitting this information “would really help in our request for records.”
Alonza Cruse, the director of pharmaceutical quality operations in FDA’s Office of Regulatory Affairs, added that “good communication is important, start getting introductory questions, maybe do a test of the technology” used for the audit. Cruse added that it is important to have a “good point of contact or a translator to help us understand what is going on.”
Inability to get to “deepest” areas
Yet during the discussion at the end of the summit, some regulators voiced frustrations with desktop assessments and virtual audits, saying they are no substitute for on-site inspections.
Vladislav Shestakov, the deputy head of the Russian GMP Inspectorate, said that a major drawback is the inability of regulators to get access to the “deepest areas of the manufacturing site” because they are not actually onsite.
Despite this shortcoming, the country has conducted 300 distance assessments over the past year since the pandemic began.
Klaus Eichmueller of Germany’s Darmstadt regional council concurred that it is “much harder to view some things through a distant assessment, that is why we would not say that a distant assessment is comparable to an onsite inspection.”
Marisa Delbo, a consultant for AIFA, the Italian Medicines Agency, and former head of GMP API inspections and manufacturing, said that the virtual inspections are “more time consuming and not as good as the onsite inspection. We hope to resume onsite inspections as soon as possible.”
Jacques Morenas, the technical advisor for the inspections division director for the French Agency for the Safety of Medicines and Health Products (ANSM) said that “I agree with Marisa. For the vast majority [of products] we hope to be back to onsite inspections not just for GMPs but for other types of inspections as well.”
Joey Goews, the team lead of inspection services of the World Health Organization’s prequalification team agreed that “[W]e need to be back to onsite inspections.”
ISPE’s 2021 global pharmaceutical regulatory summit


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Tags: EMA, FDA, GMP, Inspections

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