“How Can Clinical Trial Sites Prepare for a GCP Inspection?”

Organizations must ensure that inspection readiness is incorporated into their daily operations and procedures and that it is given the same importance as other operational priorities.

Here are some strategies that can be implemented to ensure preparedness for good clinical practices (GCP) inspection:

Organizations must routinely allocate time to do some housekeeping since GCP inspectors often come unannounced.

Senior management needs to recognize the importance of being inspection ready and provide adequate time and resources to allow readiness activities to be done on an ongoing basis.

Organizations can implement inspection readiness activities such as a mock inspection to identify new and unforeseen weaknesses and risks that need to be addressed.

The COVID-19 pandemic poses an evolving challenge to NGC inspection and may change the way inspections are conducted.

Remote or hybrid inspections could be the norm in the future.

This will require organizations to have adequate infrastructure and technology to host remote inspections and provide GCP inspectors with virtual access to their study documentation or their Trial Master File.

 3 KEY POINTS

  1. A GCP inspection is one of the most stressful experiences for people working in clinical trials.
  2. To avoid stress and potential problems, organizations must routinely and proactively prepare for an inspection.
  3. They must also foster a strong culture of day-to-day inspection readiness and be prepared to deal with the changes that the COVID-19 crisis will bring.

Specific inspection readiness activities can pay dividends in situations where an organization may lack inspection experience or where it may be advantageous to prepare an organization through exposure to an unfamiliar inspection type,” says freelance GCP auditor and Closed Loop Quality director Iain Pulley.

Article source: https://www.clinicalleader.com/doc/how-to-prepare-for-a-gcp-inspection-during-covid-and-beyond-0001

#ClinicalTrials, #GCPInspection, #COVID-19, #NGC, #GCP

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