The global pandemic of COVID–19 changed the thinking and behavior of many people and industries, and they were forced to work from home. The pharma industry was no exception, and it, too, witnessed different varieties of work environments. Regulatory bodies also switched to remote inspection of pharma drug manufacturers by using various communication techniques.
The decision to switch to remote inspection was evident because a pharma drug manufacturer cannot manufacture and market its product without regulatory approval, and most importantly, the healthcare industry worldwide was facing immense pressure to keep the supply of essential and lifesaving drugs normal. Otherwise, it could increase the impact of the global pandemic.
After the pandemic, the practice of remote inspection continued due to the added advantages, mainly due to the commitment of the pharma industry and regulatory bodies.
What is remote inspection in the pharmaceutical industry?
Remote inspection is performing inspection without being physically present on the site. It is performed through an appropriate communication medium that allows inspectors to view, examine and determine the process, facility or product under test. In addition, it provides a regulator
• Assess regulatory compliance of pharma products, processes and manufacturing facilities.
• Efficiency of corrective actions in response to the previous inspection
• Decide about the Facility's ability to renew or grant application
The facility (pharma process or product) owner is responsible for making arrangements for a successful remote inspection, and inspectors must be satisfied with components used during remote inspection.
Remote inspection in the pharma industry first gained acceptance in the era of COVID–19 due to limitations in travel worldwide. Since, without inspection, no pharma facility can produce pharma drug products, remote inspection was carried out to overcome travel limitations.
The pharma industry learned many lessons during this period, such as improved technology and processes, leading to a better remote inspection culture, criteria and routines. Although still in its initial stages, remote inspection is gaining acceptance as an alternative to physical inspection by both pharma drug manufacturers and regulatory bodies.
How is remote inspection performed?
Like other pharma-related activities, the remote inspection is performed according to the approved procedures, and the pharma product entity (for which inspection is performed) must follow these guidelines.
This section presents a procedure for performing remote inspections according to the United States FDA.
In its guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities Guidance for Industry", the FDA describes how it intends to perform remote inspection of a facility, which we will brief below.
INITIAL PREPARATION
Facility selection and notifying facility owner / responsible
The FDA does not accept requests to perform remote inspections from pharma entities and solely decides itself, whether to do a remote inspection. When selecting a facility for remote inspection, the FDA uses various risk management methods and tools to determine the possibility of performing remote inspection.
When a facility is selected for a remote inspection, the FDA informs the relevant pharma entity about the decision through electronic correspondence. The FDA shows its interest to participate in remote inspections, including document and data sharing , livestream video, and screen sharing.
Upon confirmation, the FDA confirms the point of contact, planning, and ability of a pharma facility to communicate remotely and electronically share documents.
Afterwards, the FDA appoints an FDA lead to work with the Facility to plan the activity. Agreement to these requests and activities, or informing the FDA about any challenges is necessary. Otherwise, it could affect the agency's timely compliance decision.
Preparation
After the pharma entity confirms, the FDA begins the process by introducing the remote inspec...
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