News about GMP/cGMP

17.12.2021

ICMRA: Authorities summarise global experiences on remote inspections

ICMRA: Authorities summarise global experiences on remote inspections

The International Coalition of Medicines Regulatory Authorities, ICMRA, has published a comprehensive reflection paper on experiences with different inspection models to maintain GCP and GMP inspections during the covid pandemic. The working group responsible for the paper was composed of representatives from various regulatory agencies around the world. To anticipate the group's conclusion: Remote inspections enable minimal regulatory oversight during the pandemic but will not be able to replace on-site inspections in the future.


Chaired by the UK MHRA, the working group gathered representatives from the US FDA, EMA, Health Canada and Swissmedic, German Pei, TGA Australia, PMDA Japan, ANVISA, Saudi FDA, WHO and regulators from Spain, Ireland, France, and Singapore.

The 15-page reflection paper Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 pandemic provides a good insight into the experiences that the different authorities have had with the new inspection models.  It offers answers to the question on whether and how they could be used in the future. According to the ICMRA, there are limitations.

It describes the experiences gained with

  • the decision-making processes for the use of remote inspections, based on a risk-based approach
  • the necessary technical requirements for remote use
  • the provision of documents, their access or even their provision duration
  • the possible logistical challenges
  • the training constraints for new inspectors
  • hybrid inspections

The paper concludes that some regulators from the working group are indeed looking at a future use of remote inspections, while others do not believe that the concept of remote inspections will be a permanent solution. Overall, remote and hybrid inspections are seen as an "additional tool" for inspections that may be used after the pandemic. But it is seen difficult to replace an inspector's on-site walk-through with visual technology.

"Although this document is a reflection paper and not a guidance document, the lessons learned provide valuable insight into how regulators have managed regulatory surveillance, inspections and assessments during the pandemic to support both COVID-19 management and GMP and GCP inspections in the normal course of business," so the UK MHRA, chair of the group.


Source:

ICMRA: Reflection Paper


 

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