How to Perform a Mock Audit to Simulate a Regulatory Inspection

Each pharmaceutical producer hopes to successfully emerge from a regulatory inspection, which is not possible just because it wishes to do so. Food and Drug Administration (FDA) inspections, as well as other regulators like MHRA, EMA, WHO are scheduled as surprise or unnotified inspections, which quickly spot shortcomings missed by normal internal audits. The difference between a successful inspection and generally a long list of observations rests exactly on the mock audit, a very important event that is not highly valued by many firms.

In contrast to normal self-inspection, the mock audit is aimed at imitating the pressure, speed and requirements of a real regulatory inspection. It checks not only the quality systems of a firm but also the preparation of the people, the correctness of the documentation and the capacity of the organization to act confidently in front of inspectors.

From my experience, the most useful mock audits are the ones that make people slightly uncomfortable. If everyone knows answers to all the questions in advance, the mock audit loses its purpose.

Mock Audit is not the Same as Internal Audit

Many organizations confuse the concepts of internal auditing and mock auditing. However, the two serve quite distinct purposes.

An internal audit is primarily intended to check for compliance with the company procedures and GMP regulations in order to verify whether quality systems function correctly, as well as to find ways of improving them.

On the contrary, the mock audit is performed from the viewpoint of a regulatory inspector. During such an audit, the auditors intentionally interrogate various decisions, ask for unexpected documents, trace data, communicate with the staff and check the efficiency of the quality systems. The purpose of a mock audit is to evaluate the performance of the organization in case of a regulator's visit.

Define the Inspection Scenario

Prior to the commencement of the audit, select the type of inspection scenario to be conducted. For instance, the following types of audit scenarios can be selected:

• A general GMP surveillance inspection
• A pre-approval inspection (PAI)
• An inspection to verify data integrity
• A sterile manufacturing inspection
• An inspection focusing on process validation
• A follow-up inspection after previous audit

Ensure that the scope is commensurate with that of the audit facility in terms of products, processes and commitments to compliance.

Regular changes in the audit scenario help avoid predictable types of preparation for the inspection.

Select Independent Auditors

It is essential to point out that having auditors who are too familiar with the department undergoing the audit process is one of the shortcomings of mock audits. If possible, the audit team should comprise:

• Staff members from other company locations
• Corporate quality personnel
• Independent GMP consultants
• Well-experienced auditors who are not linked to the daily operations of the department being audited

Independent auditors are better positioned to find problems that in-house teams have learned to treat as "normal".

The audit team also needs to familiarize itself with the inspection style of the agency being simulated during the process. For example, an FDA audit varies from an MHRA or WHO audit both in terms of the questioning method and kind of documentation used.

Plan the Audit Like Regulators Do

Regulators do not necessarily adhere to the organizational structure of a company. Instead, they concentrate on processes, goods and information.

Therefore, an effective practice audit should focus on a product or production line rather than on the organizational diagram according to which departments within the company would be checked.

For instance, an auditor needs to examine a recently produced batch of goods located at the following points of the manufacturing process:

• Receiving and approving raw materials
• Storage conditions in a warehouse
• Records of batch production
• Cleaning logs of a device used in the manufacturing
• Records of calibration performed
• Results of environmental monitoring
• Tests performed in laboratory
• Making a final decision on a batch
• Corrective and preventive actions related to nonconformities
• Electronic proof of batch release

This approach tests the integrity of the entire quality system rather than isolated departments.

Conduct Opening Meetings Professionally

Conduct opening meetings with full professionalism. The agenda of the meeting includes:

• Introduction of the auditors
• Scope of the inspection order
• Goals of the inspection
• Who from the department will attend
• How to communicate among the parties
• How to request documentation

Do not give long introductions aimed at giving a good impression. In fact, regulators like short introductions to the meetings and a close inspection of facilities straight away.

Interview Employees at All Levels

A key factor in the mock audit process is to evaluate staff’s reaction under stress. The interview should include staff from various departments, such as:

• Production staff
• Quality Assurance staff
• Analysts
• Engineers
• Warehouse operators
• Maintenance staff
• Supervisors

Questions should be of practical nature, rather than theoretical.

For example:

• “Show me how you record a deviation.”
• “How do you confirm cleaning of the equipment before use?”
• “What would you do if you notice an incorrect record in the logbook?”
• “How do you assure that the instrument is calibrated?”

The staff should demonstrate confidence and follow the relevant documented procedures instead of providing a personal opinion.

Follow the Data Trail

The modern approach towards regulatory audits focuses mainly on the data integrity. Now, auditors are required to go beyond printed reports and check the source documents. Some examples of source documents include:

• Electronic chromatograms
• Audit trails
• Laboratory notebooks
• Electronic logbooks
• Calibration databases
• Equipment history records
• Environmental monitoring applications

In cases of discrepancies between the source data and the final reports, the regulatory auditors must investigate them immediately.

Observe Shop Floor Practices

Simply documenting does not prove compliance with good manufacturing practices. Make it a point to observe the manufacturing process. Focus on the following points:

• Gowning practices
• Flow of materials
• Movement of people
• Tags on machines
• Cleanliness
• Documentation executed in real time
• Identification of materials and machines
• Housekeeping practices

Most regulatory observations are based on what inspectors see, rather than what they read.

Challenge Documentation

Effective mock auditing is more than just confirming that documents are available. Instead, you should ask questions like:

• What was the reason for closing the deviation with only one CAPA?
• By what means the acceptance criterion was determined?
• Why is revalidation seen as not needed?
• What scientific rationale backs up this conclusion?
• What is the justification for closing the CAPA in view of repeating deviations?

These types of questions will stimulate critical thinking and highlight issues often overlooked in the routine examination of documents.

Record Findings Based on Risk

Not every finding is equally important for product quality. Organizing findings based on risk allows management to determine the priority of corrective measures. Possible classifications are as follows:

1. Critical Findings

These issues may compromise patient safety, product quality or data integrity.

2. Major Findings

These findings indicate serious GMP violations that prompt corrective action, purely with respect to GMP.

3. Minor Findings

These can include issues related to documentation errors, sporadic deviations from procedures or simple housekeeping concerns.

Achieving this allows to use resources where they matter the most.

Conduct a Factual Conclusion Meeting

A conclusion meeting should look like a final discussion of federal inspectors. One should convey findings simply and objectively, supported with evidence. Individuals should not be blamed.
Instead, one has to mention:

• What was seen
• Why it is problematic
• What regulation/procedure should be used
• The possible influence on product quality
• The suggested corrective measures

The attendance of top management is very important because common corrective measures imply leadership support and resources allocation.

Learn from the Findings

The result of a simulation audit is pointless if it is simply put away without any meaningful follow-up. Each observation must be carefully considered against the following criteria:

• Root cause
• Immediate correction
• Corrective action
• Preventive action
• Verification of effectiveness
• Timeliness of implementation
• Who is responsible for the implementation

A frequent result from the mock audit frequently indicates problems with quality culture, not separately occurring procedural errors.

Common Mistakes During Mock Audits

Though organizations wish to perform mock audits correctly, there are various mistakes that may lower their efficacy. These may be:

• Letting departments know in advance enough.
• Allowing groups to prepare their documents for the audit beforehand.
• Asking expected questions only.
• Neglecting electronic documents.
• Carrying out audit only on paper but not on-site.
• Failing to question scientific decisions.
• Closing the points without checking upon CAPA.
• Using the exercise as a checklist instead of a mock inspection.

A mock audit should expose weaknesses, not create a false sense of confidence.

Building an Inspection-Ready Culture

Being inspection-ready should not commence one month prior to the arrival of inspectors; it needs to be a daily occurrence. Successful organizations that perform well during inspections:

• Conduct mock audits throughout the year.
• Rotate auditors with fresh experience.
• Regularly review past findings.
• Train employees on inspection behavior and etiquette.
• Verify effectiveness of CAPAs before closure of actions.
• Incorporate inspection readiness into routine quality management reviews.

When employees know that inspections are something that is going to occur every day, visits from inspectors become a matter of validating good procedures instead of a stressful event.

A mock audit that has been well-designed is one of the most powerful ways to evaluate regulatory readiness in the realm of pharmaceuticals. By employing the methodologies, questioning processes and expectations of regulatory inspectors, organizations are able to highlight their deficiencies before they become recognized observations. The worth of a mock audit rests in the potential to develop processes that ensure quality, instill confidence among employees and promote the adherence to regulations.

In my experience, the most successful organizations are those that view mock audits as opportunities for learning rather than assessment. If a mock audit is done in an independent way and followed by corrective actions, it can allow an organization to perform the best practice in the field of product quality and patient safety.

Regulatory References

1. FDA Investigations Operations Manual (IOM)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual
2. EU GMP Guidelines, Volume 4, Chapter 9: Self Inspection
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
3. WHO Good Manufacturing Practices for Pharmaceutical Products
https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/gmp

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