It is rare for a regulatory inspection to be problematic because one of the inspectors may ask a surprise question. Problems are usually caused by the fact that the organization does not know how to demonstrate the actual actuality of its operations.
While a process may be in compliance, it does not mean that current practices are in line with the procedures. The batch record may be complete, but obtaining necessary supplementary records may prove to be difficult. The employees might be familiar with the procedures they follow without being able to explain why the procedures are conducted. This where a mock inspection comes into play.
Unlike a simple internal audit performed a couple of weeks before a planned FDA, MHRA, or other inspection, a good mock inspection is a simulation that is meant to check whether the facility can show that it is under control in inspection conditions.
In carrying out mock inspections, requests for documents, interviewing of employees, inspection of facilities, assessment of records, verification of data integrity and observation of the work in the field are made.
The aim is not to ask employees to memorize answers. Instead, the aim is to find out if the site can produce reliable evidence of its GMP activities.
Mock inspections are best conducted by individuals who can objectively assess the site. Such individuals may include expert internal auditors, corporate quality experts and previous regulatory employees.
An inspector may begin in a manufacturing site, see something interesting taking place and ask for the respective SOP, followed by a request for the training records, the deviation records, equipment history or the previous investigation reports related to this practice.
Asking one question can lead to many other questions. A mock inspection has to be done in this fashion. For example, if during the inspection the inspector sees an operator who is checking temperature while manufacturing, the mock inspection team should ask questions like:
Quality assurance systems are usually thoroughly scrutinized. Inspectors can analyze deviations, CAPA, changes, complaints, product quality reviews, investigations, risk assessments and management oversight too.
Another crucial area is data integrity. Inspectors must question if the electronic and paper documents are reliable, readable, written in real time, original or proper copies, as well as accurate. They should review audit trails as well as systems of access, backups, deleted or changed documents and data from laboratories.
Another significant area is production and manufacturing areas, which should be investigated through the active studying of manufacturing processes and production procedures rather than only through reviewing documentation. The condition of machinery and equipment, cleanliness of equipment, materials used in the process, in-process testing and operators’ actions should be evaluated too.
QC laboratories should be checked with respect to analytical methods, suitability of the system, out of specification/out of trend issues, reference standards, equipment capability, chromatography studies, calculations performed and raw data verification.
Utilities must also be assessed, including water systems, HVAC, compressed gases and clean steam.
The employees should be interrogated in an informal way in a mock inspection.
For example, one could ask:
"What will you do if you made a mistake in a history log?"
Or
"What can you do if you notice that a label for an equipment operation is missing?"
The goal of the questions is not to check how the employees can repeat the SOP, but see if they understand and are capable of performing the task correctly.
It is important that the employees are properly trained to expose issues rather than providing fictitious answers. In case of a poor performance being detected during the inspection, it should lead to improvements within the organization.
Let’s say, for instance, that a deviation concerning a manufacturing batch has been picked.
The reviewer starts examining the deviation by asking for the following records:
For instance, a deviation may say that the root cause was the operator’s fault, while CAPA emphasizes modifying equipment.
Instead of asking if the calibration has been performed, you should rather ask:
“Give me the latest calibration report.”
In a similar way, you should not ask if the specialists were trained, you should rather ask:
“Give me the training report of this technician.”
This method is suitable for identification of gaps in documentation, difficulties to find documents, discrepancy of documents as well as the weaknesses in the evidence.
The findings should be divided up according to their effects on the product and regulatory compliance. All crucial weaknesses should be immediately addressed, while all other findings can be included in a general plan for fixing the problems.
It is also important to find out the root cause of the problems. Fixing just one specific document may not help solve a bigger problem that triggers many findings.
For instance, if several SOPs have defective information, the problem might not be only related to the defective document. It might be necessary to analyze the document management system, periodic reviews, or the ownership of the document.
Each important finding should have a responsible person, a plan of action and a way of analysis of how they have fixed the problems.
Instead, it is important to introduce an element of unpredictability. It is possible to use random records and interview various personnel, use follow-up questions and navigate through departments.
The goal is to test the system, not the company’s ability to react during a rehearsal.
Each facility should assess its regulatory compliance history, product safety and security risks and any changes made at that facility before deciding how often to conduct mock inspections.
A thorough mock inspection is especially useful before an upcoming regulatory audit since organisations should not wait until the last moment to carry out inspections.
Regular risk-based mock inspections produce many more insights on the readiness of the facility for inspections.
Download Mock Inspection Checklist
The FDA Quality Systems Approach to Pharmaceuticals cGMP Regulations stresses the importance of having an effective pharmaceutical quality system as well as systems of management controls. FDA regulations that deal with inspection also stress the importance of documentation and investigations, data integrity and management systems.
In case an inspector knocks on the door tomorrow, will the location be able to demonstrate that it is in control of its processes?
The answer will depend on various factors and having approved Standard Operating Procedures is not enough. The personnel should be aware of their roles, the records should show the reality and the data should be trustworthy. The investigations should be performed properly and the documentation should be accessible.
The most effective mock audits look for the weakest points of the organization. They work with evidence trails, ask unpleasant questions, interrogate employees and check primary data compliance.
The mock audit will be of practical use during the next real inspection and find all the shortcomings.
Unlike a simple internal audit performed a couple of weeks before a planned FDA, MHRA, or other inspection, a good mock inspection is a simulation that is meant to check whether the facility can show that it is under control in inspection conditions.
What is a Mock Inspection?
Mock inspections are planned evaluations that mimic the actions and behavior of a regulatory inspector.In carrying out mock inspections, requests for documents, interviewing of employees, inspection of facilities, assessment of records, verification of data integrity and observation of the work in the field are made.
The aim is not to ask employees to memorize answers. Instead, the aim is to find out if the site can produce reliable evidence of its GMP activities.
Mock inspections are best conducted by individuals who can objectively assess the site. Such individuals may include expert internal auditors, corporate quality experts and previous regulatory employees.
Start With the Inspector's Perspective
One mistake made by companies is to hold a mock inspection using their internal audit checklist. A regulatory inspector does not have to follow the stages in the company's internal audit procedure.An inspector may begin in a manufacturing site, see something interesting taking place and ask for the respective SOP, followed by a request for the training records, the deviation records, equipment history or the previous investigation reports related to this practice.
Asking one question can lead to many other questions. A mock inspection has to be done in this fashion. For example, if during the inspection the inspector sees an operator who is checking temperature while manufacturing, the mock inspection team should ask questions like:
- What is the acceptable range?
- Where is it documented?
- What happens when the parameter is outside the range?
- Show me the relevant batch record.
- Show me if the equipment is calibrated.
- Has the equipment been out of order?
- Show me other deviations related to the equipment.
- How were these deviations investigated?
Things That Require Special Attention
The design and procedures of mock audits have to match the risk profile of the facility.Quality assurance systems are usually thoroughly scrutinized. Inspectors can analyze deviations, CAPA, changes, complaints, product quality reviews, investigations, risk assessments and management oversight too.
Another crucial area is data integrity. Inspectors must question if the electronic and paper documents are reliable, readable, written in real time, original or proper copies, as well as accurate. They should review audit trails as well as systems of access, backups, deleted or changed documents and data from laboratories.
Another significant area is production and manufacturing areas, which should be investigated through the active studying of manufacturing processes and production procedures rather than only through reviewing documentation. The condition of machinery and equipment, cleanliness of equipment, materials used in the process, in-process testing and operators’ actions should be evaluated too.
QC laboratories should be checked with respect to analytical methods, suitability of the system, out of specification/out of trend issues, reference standards, equipment capability, chromatography studies, calculations performed and raw data verification.
Utilities must also be assessed, including water systems, HVAC, compressed gases and clean steam.
Interviewing Employees Is One of the Most Valuable Parts
An assessment will quickly show the difference between existing compliance policies and the actual knowledge of the employees.The employees should be interrogated in an informal way in a mock inspection.
For example, one could ask:
"What will you do if you made a mistake in a history log?"
Or
"What can you do if you notice that a label for an equipment operation is missing?"
The goal of the questions is not to check how the employees can repeat the SOP, but see if they understand and are capable of performing the task correctly.
It is important that the employees are properly trained to expose issues rather than providing fictitious answers. In case of a poor performance being detected during the inspection, it should lead to improvements within the organization.
Examine the Evidence Trail
One of the most effective methods used during a mock inspection is the examination of an issue across many records.Let’s say, for instance, that a deviation concerning a manufacturing batch has been picked.
The reviewer starts examining the deviation by asking for the following records:
- Root cause analysis
- Impact assessment
- Corrective and Preventive Action (CAPA)
- Verification of the effectiveness
- Associated change control records
- Training records
- Past similar deviations
- Batch records
- Quality of product review
For instance, a deviation may say that the root cause was the operator’s fault, while CAPA emphasizes modifying equipment.
Effective Method of "Show Me"
The important formula to take into consideration during training is the fact that you should not take answers as provision of information when documents should be present.Instead of asking if the calibration has been performed, you should rather ask:
“Give me the latest calibration report.”
In a similar way, you should not ask if the specialists were trained, you should rather ask:
“Give me the training report of this technician.”
This method is suitable for identification of gaps in documentation, difficulties to find documents, discrepancy of documents as well as the weaknesses in the evidence.
What Happens After the Mock Inspection?
The benefits of a mock inspection are dependent on what happens next.The findings should be divided up according to their effects on the product and regulatory compliance. All crucial weaknesses should be immediately addressed, while all other findings can be included in a general plan for fixing the problems.
It is also important to find out the root cause of the problems. Fixing just one specific document may not help solve a bigger problem that triggers many findings.
For instance, if several SOPs have defective information, the problem might not be only related to the defective document. It might be necessary to analyze the document management system, periodic reviews, or the ownership of the document.
Each important finding should have a responsible person, a plan of action and a way of analysis of how they have fixed the problems.
Avoid Turning the Exercise into a Performance
Mock testing should not evolve into a training situation in which staff are told what they will be asked and what responses they need to prepare. This creates an illusion of readiness.Instead, it is important to introduce an element of unpredictability. It is possible to use random records and interview various personnel, use follow-up questions and navigate through departments.
The goal is to test the system, not the company’s ability to react during a rehearsal.
How Often Should Mock Inspections be Conducted?
There is no one-size-fits-all frequency that is suitable for every single pharmaceutical facility.Each facility should assess its regulatory compliance history, product safety and security risks and any changes made at that facility before deciding how often to conduct mock inspections.
A thorough mock inspection is especially useful before an upcoming regulatory audit since organisations should not wait until the last moment to carry out inspections.
Regular risk-based mock inspections produce many more insights on the readiness of the facility for inspections.
Download Mock Inspection Checklist
Regulatory Prospective
Mock inspections are not required by regulation in any one acceptable format, but they can be an effective tool for determining compliance with GMP and readiness for inspection.The FDA Quality Systems Approach to Pharmaceuticals cGMP Regulations stresses the importance of having an effective pharmaceutical quality system as well as systems of management controls. FDA regulations that deal with inspection also stress the importance of documentation and investigations, data integrity and management systems.
In case an inspector knocks on the door tomorrow, will the location be able to demonstrate that it is in control of its processes?
The answer will depend on various factors and having approved Standard Operating Procedures is not enough. The personnel should be aware of their roles, the records should show the reality and the data should be trustworthy. The investigations should be performed properly and the documentation should be accessible.
The most effective mock audits look for the weakest points of the organization. They work with evidence trails, ask unpleasant questions, interrogate employees and check primary data compliance.
The mock audit will be of practical use during the next real inspection and find all the shortcomings.
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