Remote Inspections in the pharmaceutical industry

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 inspection and its various components and requirements, usually through visual meeting program. Some key points that the FDA can introduce include, but are not limited to,

• The scope and the limitations of the activity

• Introduction to the FDA team, involve in performing the remote inspection and its lead

• Identifying all concerned persons, such as point of contact and other relevant personnel

• Schedule and duration of the entire activity

• FDA's expectation of live streaming

• The difference of time zone between the regulator and the pharma facility

• Methods of sharing relevant documentation and other data

• Limitations in electronic tools that could affect the entire and continuous activity

• Checking and ensuring adequate quality, strength  and speed of internet connection required during the activity

CONDUCTING ACTIVITY

On the whole, the United States FDA expects that the pharma facility (of which the inspection is being carried out) to treat the remote inspection with the same importance as that of physical inspection by ensuring transparency, availability of relevant staff and the operational facility, enabling the inspectors, to analyze  actual pharma operations.  

If, during the remote inspection, the FDA determines that the pharma facility cannot provide the required online interaction tools, the FDA will cancel the remote inspection and switch to physical inspection or some other means. 

Some processes that can be performed during remote inspection include, but are not limited to 

• Document and record review

• Facility, operation and document examination during live stream. A pre-recorded video of such can also be used

• Addresses questions and conducting interviews through the point of contact

• Evaluate corrective actions, if any. For corrective actions, the FDA may opt for a physical inspection instead of a remote

• Update the inspection committee on the outstanding issues and observations.

TECHNOLOGY REQUIREMENTS

The pharma facility is responsible for providing all the required technology and connection-related devices for smooth remote inspection. Technology components should be able to give a clear view of operations in the pharma facility. If any problem arises, the pharma facility is responsible to resolve it promptly. 

For security and other reasons, the FDA will use its own technology and connectivity components during the remote inspection, and it includes any of the following

• Microsoft Teams  

• Zoom for Government 

• Adobe Connect

DOCUMENTATION AND RECORD EVALUATION

Usually, the FDA review documents and records in advance to enable smooth remote inspection. However, it is expected that the FDA may request additional documents during the online session in exceptional circumstances, such as in response to an observation. In this case, the pharma manufacturer must provide agreed timetable for submitting the documents 

The documents must be provided electronically or through screen sharing; the FDA will provide a source. The language of the documents must be English. In case of non-English, the pharma manufacturer must provide a translator. 

The pharma facility is responsible for identifying password-protected files so that the FDA can open the document.  

If the pharma facility's documentation is in paper form, it is responsible for making arrangements enabling the FDA to remotely view and verify documentation using appropriate means such as scanning.

CONCLUDING THE ACTIVITY

The FDA will hold the final meeting with the facility management when the entire activity is completed. The FDA will present written observations to enable facility owners to understand and prepare responses. 

The observation presented does not reflect the agency's final decision and will not issue Form 483.  Additionally, the FDA gives 15 business days to respond against these observations. 

At this stage, the FDA may collect any documentation or information for other reasons (other than regulatory) and include, but not limited to

• Support the FDA's decision on whether to approve or disapprove the application

• Follow-up inspection due to any deviations 

• Support any regulatory action such as a warning letter, import alter, recall or enforcement action

• Ranking a facility or conducting  a cGMP action

• Follow-up or compliance action

A copy of the observation is handed over to the facility representative, which may be subject to the Disclosure Act. If re-inspection is necessary, these observations will be used for preparation.

What is the thinking of Regulatory bodies, especially the FDA?

As with many pharma processes, remote inspection is governed by strict regulatory regulations, allowing a pharma facility to perform remote inspection. 

This section presents some regulatory guidelines according to the United States FDA.

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities Guidance for Industry

In this guideline, the FDA provides an overview of the primary remote inspection activity, requirements required by the pharma organization, generalized procedure and the outcome of the activity. Its essential points have been discussed in the previous section.

FDA issues guidance on using remote oversight tools to help approve drugs

It provides details of the tools used by the United States FDA, during the remote inspection to oversee the Facility, used instead of traditional inspection for the FDA's drug review process named in pending applications. 

The FDA also acknowledges the importance of this guideline stating its importance in maintaining operational flexibility in reviewing drug applications and facility evaluations. 

In this guide, the FDA focuses on a risk-based approach to determine whether alternate tools, such as requesting manufacturer records, remote evaluations and records from foreign regulatory bodies, can work.

The FDA's alternate tools help the agency determine whether the manufacturer can implement proposed actions to produce quality goods. However, using these tools are is not considered inspect, but rather instead of inspections. 

This guidance also states the success of alternate tools during COVID – 19 pandemic. 

This guidance does not apply to other inspection programs such as post-approval inspections, follow-up, and bioresearch monitoring inspections.

About The Author

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.