Preparation for Regulatory Inspections with answers to potential issues
Preparation for Regulatory Inspections with answers to potential issues

Preparation for Regulatory Inspections with answers to potential issues

Introduction

A regulatory audit always requires a lot of last-minute planning. During this period, new issues emerge while old ones resurface. The observed issue might be Critical, major, or minor. Some are under process, partially rectified, or left untouched for several reasons. 

When the inspection is at the doorstep, the best approach is to find an answer to ‘what is the way to explain and address this issue in the best possible manner?’

What is the objective of the inspector during the regulatory inspections?

Keep yourself in the inspector’s shoes. The obvious answer is patient safety. The prime responsibility of any regulatory auditor or investigator is to ensure patient safety and regulatory compliance. As soon as an inspector discovers an issue, the first thing that comes to mind is how the organization will handle the issue and what risk assessment and mitigation strategies the firm is adapting to resolve the issue.

Source of information through which the inspector could identify the issues.

A. Natural ways are:

• Facility tour

• Interactions between shopfloor staff and inspector

• Equipment operation and cleaning logs

• Area logs 

• Batch manufacturing and packaging records

• Quality Management System tools such as deviations, investigations, CAPAs, etc.

• Annual Product Quality Reviews

• Laboratory notebooks and logs

• Customer complaints and recall logs, etc.

B. Other sources are:

• Customer Complaint

• Product recalls

• Field alerts

• Whistleblower

How inspector could pursue the image of your organization by looking at issues and mitigation strategies of the firm

The firm’s approach toward resolving an issue makes a big difference and builds an image of the firm and the quality culture of the firm. In addition, how firms handle issues reveals much about their employees and company to the inspector.

The most critical point is the company’s attitude toward patient safety seriousness. Does the company want to solve the issue permanently or do patchwork? Company’s vision and quality culture. It is relatively easy for the inspector to figure out this. 

Efforts made towards the resolution of issues by management and support to the staff for resolution of issues rather than blaming people speak a lot about management and quality culture.

The mitigation strategy should have interim controls, a close monitoring plan, and a long-term plan to solve the issue permanently.  

What is the inspector’s expectation for handling the issues effectively?

When the firm starts presenting the issue, firstly, the inspector tries to understand the problem definition of what exactly has gone wrong. The simple steps to explain the problem are by answering the questions of 5W2H – What, Why, When, Who, Where, How, How many/ How much.

Inspector wants to know that firm has understood the issues adequately enough so that further steps of investigation and root cause identification by the firm go in the right direction toward problem resolution.

Inspector will verify that the root cause is identified adequately, whether the patient safety risk is addressed adequately and whether the problem is viewed from a holistic perspective. Therefore, the root cause or most probable cause must be evidence-based, science-based, or data-driven.

After identification of the root cause, it is crucial to identify the corrective and preventive actions with target timelines. 

It is also essential to define the implementation timeline judiciously and monitor and track it until it is done. 

Effective monitoring is done after-implementation of the corrective and preventive actions to understand whether the issue is adequately addressed to prevent reoccurrence. 

Essential points to satisfy the inspector during regulatory inspections

People speak the same language confidently and accurately and could demonstrate the same with evidence and data. The information should be available in hand and easily accessible to showcase the entire picture accurately. This readiness can effectively convince anyone that the firm is on the right track to resolving the issue.

Speed is the key. As soon as you would be able to explain without any hesitation will make satisfy the inspector. Hesitation or unclear pictures for a longer time will make the inspector more concerned.

How should any firm prepare for such situations?

• The firm management, key stakeholders, and subject matter experts should be clear about the issue. There should not be any surprises on the day of the inspection.

• Adequate documentation with quality risk assessment should be available in the place.

• Person responsible and accountable must be identified well in advance to explain the issue adequately with the supporting documents.

Key points that the presenter should be aware

• Be truthful.

• Talk specifically about the issue and explain it in simple language and to the point. 

• Talk about the coverage of the issue and its impact and risk assessment. 

• The firm has taken what immediate actions to correct and address the issue as an immediate action. 

• How quickly the actions were taken.

• Progress of investigation 

• What is the root cause?

• Whether the identified root cause addressing the issue capable of preventing the reoccurrence?

• What is the potential impact on product quality, patient safety, and other operations?

• What are the interim controls put in place till the issue is fully addressed

• Preventive actions and their effectiveness.

• Support your discussion with the documentation and other relevant evidence. 

• Same or relevant understanding should be there for every relevant stakeholder, and it should be trained and memorized by all the relevant stakeholders.

Benefits of having the knowledge to all the stakeholders

All relevant stakeholders can be trained or self-read all the relevant documents so that the same level of understanding can be achieved and effectively address the issue. Following are the key benefits of having the same level of understanding.

• Everyone knows what happened, why it happened, what actions have been taken, and what the way forward is. 

• Makes situation effectively manageable. 

• Auditee remains confident in explaining the facts to the inspector.

• Inspector will get convinced, reflecting the firm’s quality system’s maturity. 

Conclusion

The prime responsibility of any regulatory auditor is to ensure patient safety and regulatory compliance. How firms handle issues reveals much about their employees and company to the inspector. The best approach is to find an answer to ‘what is the way to address this issue in the best possible manner?’. Inspector will verify that the root cause is identified adequately, whether the patient safety risk is addressed adequately and whether the problem is viewed from a holistic perspective.

The root cause or most probable cause must be evidence-based, science-based or data-driven. Adequate documentation with quality risk assessment should be available in the place. Person responsible and accountable must be identified well in advance to explain the issue adequately. All relevant stakeholders can be trained or self-read all the relevant documents so that the same level of understanding can be effectively addressed.

Being truthful and well-prepared is the key to success during the regulatory inspections!

Read following similar articles:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793

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