ICMRA: Remote inspections can complement, but not replace, onsite inspections

Regulatory NewsRegulatory News | 14 December 2021 |  By 

While there are benefits to conducting remote good clinical practice (GCP) and good manufacturing practice (GMP) inspections and these assessments can continue being used  post pandemic, these methods have their limitations, concludes the International Coalition of Medicines Regulatory Authorities (ICMRA) in a new reflection paper.
 
Among the topics ICMRA touches on in the reflection paper are the decision-making process to use remote approaches, tools for remote inspections, logistical challenges with performing remote inspections, and training new inspectors on how to conduct remote inspections.
 
In the paper, ICMRA sought to “reflect on the combined experience during remote conduct of evaluations, inspections, and assessments during 2020-21, providing transparency to stakeholders on approaches taken to date during the pandemic.”
 
The paper drew from the collective experience of an ICMRA working group chaired by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and representatives from 14 regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, Swissmedic, and Ireland’s Health Product Regulatory Authority (HPRA).
 
The group said it “found remote inspections an enabling tool to maintain at least a minimal regulatory oversight during the pandemic.” However, the authors noted that “it is not the view of the group that remote inspections would fully replace an on-site inspection programme.”
 
The paper notes that remote digital technology tools have been applied “proficiently” in the areas of GCP inspections that involve electronic systems, such as auditing trial master files, electronic case report forms, electronic patient reported outcomes, and electronic document management systems.
 
Yet, there are limitations to using remote inspections at investigator sites. Some authorities said it was “crucial to avoid any undue burden on investigator site staff during the time of the pandemic.” The paper also noted that “the inspection of source documents may not be possible due to local legal requirements concerning accessibility and data protections.” Remote inspections are not currently feasible at investigator sites within the EU, the authors noted.
 
Also, some facilities, such as hospitals wards, clinics, pharmacies, aseptic factices, intensive care facilities and clinical laboratory facilities, require hands-on evaluation of facilities and equipment, and are not amenable to remote inspections. In clinics, for example, it is difficult to review protocols and handle emergency scenarios through remote inspections. It is also not feasibleto check crash carts ortest alarms and call buttons remotely.
 
Onsite GMP inspections provide ‘useful’ information about manufacturing sites   
 
In the GMP area, ICMRA said remote audits have allowed many sites “to continue with their quality oversight programme.” Further, these audits have provided “useful” information about the manufacturing site.
 
Yet there are challenges in conducting remote assessments in facilities where the use of wireless technology is limited, or in viewing certain rooms such as metal chambers containing refrigerators, rooms holding stability samples, or instrument rooms housing large number of high-performance liquid chromatography (HPLC) equipment.
 
The paper also notes that certain aspects of inspections cannot be performed with “the same rigor” as onsite inspections. The view afforded by cameras is limited by such factors as field of view, focus and resolution; these limitations make a remote inspection far more complicated and inefficient than a physical walk-through, explained the authors.  
 
“The inability for an inspector to walk up to and point at equipment during virtual tours made communication more challenging and the inspection process significantly slower, for example if reviewing complex pipe layouts for processes or water systems when discussing potential dead-legs in equipment design,” wrote ICMRA by way of example.

 
Risk assessment has to be part of considering whether a remote GMP inspection is feasible and desirable, according to the authors, who recommended considering whether risk could be reduced by a shorter re-inspection cycle or using supplementary data.
 
The paper also introduces the concept of “observational complexity,” saying that when considering a remote inspection, authorities should give weight to such factors as aseptic processes, bioburden, potency or product and packaging complexity
 
ICMRA offers limited support for remote assessments
 
The ICMRA working group gave cautious support for remote assessments. It said the use of these tools “has proved valuable in the protection of public health in this emergency situation.”
 
Yet the group acknowledged that “while some ICMRA working group members do not currently think it will fit within their regulatory framework, a number of regulators have expressed an interest in supplementing an inspection, or in some cases, replacing the need for an on-site inspection with remote and/or hybrid approaches, such as for addressing a narrow concern, contributing to an application assessment and approvability decision, or verifying certain corrective/preventive actions.”
 
The MHRA expressed support for the paper’s findings. “While this paper is a reflection paper, not a guidance document, the combined experience conveyed provides valuable insight into how regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections,” said the agency.
 
ICMRA reflection paper
 
 

 

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