An inspection carried out according to regulations is one of the major moments in the life of a pharmaceutical production plant. Regardless of whether the inspection is done by FDA, EMA, WHO, MHRA or any other agency, the inspectors will demand a proof that the factory has been working in the compliance mode. They will not be impressed with an industrial facility that has been tidied up and organized prior to the inspection.
In practice, however, most companies start preparations for the inspection only when the inspection has been announced. Large number of activities need to be done to finish overdue CAPAs, complete logbooks, finish training and put everything in order. All these activities may create a good start, but experienced inspectors can easily tell if the preparations made due to the necessity or as a result of planned activities.
The observations that I have made during my work with inspection ready programs show that preparation done well in advance guarantees success.
Examples include:
Trending documentation errors can reveal weaknesses in GMP compliance.
The focus in the last 30 days before inspection must be on getting employees ready for it.
The frequently requested documents are:
Examples are:
Key roles may be:
Verify the following:
Unchanged since Inspection readiness refers to a never ending operation that starts long before a notice of inspection is received. A properly defined timeline of 90, 60, 30 and 7 days of preparation, which is crucial for pharmaceutical companies, allows to reinforce quality systems, assure operational compliance, train employees properly, find problems arising in the process of preparing. Moreover, this approach allows to build an environment of everyday compliance.
As per my observation, the companies performing well on inspections do not have excellent systems but the companies having disciplined practices and capable employees. The timeline used for preparing for inspections ensures making this work systematic and avoiding reactive approach to the preparation.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspections/investigations-operations-manual
2. WHO Good Manufacturing Practices for Pharmaceutical Products
https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/gmp
The observations that I have made during my work with inspection ready programs show that preparation done well in advance guarantees success.
Why an Inspection Readiness Timeline Matters
Being inspection-ready means more than just having the documents on hand. Inspection-readiness also means confirming that numerous different quality systems are effective, that employees understand their duty, that the equipment remains qualified and that the manufacturing processes are compliant with the GMPs. Organizing a timeline will allow businesses to accomplish a number of things:- Identify necessary steps
- Eliminate any last-minute corrections
- Discover potential weaknesses
- Better collaborate with different departments
- Reduce stress related to inspections
- Improve the quality of continuous compliance
90 Days Before Inspection: Evaluate the Quality System
An essential part of a preparation for the upcoming inspection is evaluating the overall efficiency of the Quality Management System (QMS) and fixing current issues in order to do not cause unwanted stress.1. Review Quality Metrics
When evaluating the quality metrics, attention should be paid to the following points:- Deviations
- CAPAs
- Change controls
- Customer complaints
- Product Quality Reviews (PQR/APQR)
- Out-of-Specification (OOS) investigations
- Environmental monitoring results
- Stability deviations
2. Verify the Validation Program
Make sure that all validation processes are up to date, including:- Process validation
- Cleaning validation
- Computer systems validation
- HVAC qualification
- Water system qualification
- Utility qualification
- Analytical method validation
3. Carrying Out a Thorough Mock Inspection
Mocks inspections must mirror that of an actual regulation inspection and not be like an internal audit. As a minimum, the audit should include:- Production activities
- Quality control labs
- Storage areas
- Utilities
- Engineering
- Assessment of documentation
- Interviews with employees
60 Days Before Inspection: Verify Operational Compliance
Now, major deficiencies in the quality system must have already been taken care of. The focus now turns to daily applications of GMPs.1. Review Manufacturing Activities
Move through the production floors and check if routine operations are executed in line with the set instructions. Pay special attention to:- Review Manufacturing Activities
- Cleaning status of equipment
- Identification of materials
- Monitoring of labels
- Documents filled in real time
- Calibration status labels of equipment
- Housekeeping standards
2. Inspect Major Documents
Pick randomly some completed reports and see how an auditor does it.Examples include:
| Document | Common Deficiencies |
| Batch Manufacturing Records | Missing signatures, incorrect entries |
| Equipment Logbooks | Incomplete usage records |
| Cleaning Records | Missing verification signatures |
| Calibration Records | Overdue instruments |
| Preventive Maintenance Records | Delayed maintenance |
| Laboratory Worksheets | Calculation errors or incomplete documentation |
Trending documentation errors can reveal weaknesses in GMP compliance.
3. Evaluating the Data Integrity
Modern evaluations are focused more on electronic documentation. Issues like:- Audit logs
- Access rights
- Passwords
- E-logs
- Safety control methods
- ALCOA+ conformity
30 Days Before Inspection: Prepare Employees
Output quality of even the most effective system will be diminished if the workers do not know how to describe their roles properly.The focus in the last 30 days before inspection must be on getting employees ready for it.
1. Conduct Employee Interviews
Managers should be interviewing people from different departments using questions that are practical rather than theoretical. For example:a) Production Personnel
- How do you check equipment for sanitation before production?
- What will you do in case incorrect entry is found in the batch record?
b) Quality Control Analysts
- What do you do if system suitability fails?
- How do you deal with too high Out-of-Specification result?
c) Engineering Personnel
- How do you ensure that critical equipment is qualified?
- What will you do if preventive maintenance is overdue?
2. Organize Frequently Requested Documents
It is crucial to organize the documents that are frequently required. Make sure to make document master list that will make the requesting of inspection documents easier.The frequently requested documents are:
- Site Master File
- Validation Master Plan
- Organization Chart
- Training Matrix
- SOP Index
- Batch Manufacturing Records
- Product Quality Reviews
- Calibration Program
- Environmental Monitoring Data
- Annual Product Reviews
7 Days Before Inspection: Confirm Readiness
The week before the inspection should not be the time for any major changes in processes. Instead, check whether all the systems are operating properly.1. Perform a Final Facility Walkthrough
Check every GMP area looking for things that inspectors usually spot.Examples are:
- Damaged walls/flooring
- Leaking ceilings
- Accumulation of dust in the facility
- Improper storage of materials
- Missing labels on equipment
- Expired calibration labels
- Emergency exits being blocked
- Poor housekeeping
2. Check Status of Training
Have a look at training records to make sure that:- Annual GMP training is complete.
- Newly edited SOPs have been trained.
- Data integrity training is up-to-date.
- Induction training has been completed by newly hired employees.
3. Finalize Inspection Team
Make sure responsibilities are clear to key people.Key roles may be:
- Inspection coordinator
- Document controller
- Quality Assurance representative
- Production representative
- Quality Control representative
- Engineering representative
- IT support
- Subject Matter Experts
The Day Before Inspectors Arrive
Implement changes to processes or papers only when absolutely necessary. Do take care of logistics.Verify the following:
- Placement of inspection room.
- Availability of computer and printer.
- Internet connection status.
- Access to electronic files.
- Availability of required documents.
- Contact information of the key people responsible.
Common Errors in Preparing for an Inspection
There are various mistakes made on a consistent basis which inadvertently diminish the effectiveness of inspection readiness programs. List of mistakes made:- Closing out corrective and preventive action plans before verifying if they have been effective.
- Making revisions to multiple SOPs right before the time of the inspection.
- Overlooking recurring deviations.
- Advising employees to memorize answers during inspections.
- Concentrating only on the clean-up of the area in readiness for the inspection.
- Looking at documents retrospectively.
- Not reviewing electronic records in preparation for an inspection.
- Looking at inspection readiness as a one-off task.
Make Inspection Readiness Part of Daily Operations
Successful compliance organizations are not only prepared when they know that an inspection will be carried out. Inspection readiness becomes part of everyday operational work. Among key aspects of good practice:- Mock inspections performed quarterly.
- Checks of quality metrics carried out frequently.
- Regular document audits.
- Employees interviewed from time to time.
- Constant monitoring of CAPAs effectiveness.
- Periodic evaluation of data integrity.
- Checkups done by management.
Unchanged since Inspection readiness refers to a never ending operation that starts long before a notice of inspection is received. A properly defined timeline of 90, 60, 30 and 7 days of preparation, which is crucial for pharmaceutical companies, allows to reinforce quality systems, assure operational compliance, train employees properly, find problems arising in the process of preparing. Moreover, this approach allows to build an environment of everyday compliance.
As per my observation, the companies performing well on inspections do not have excellent systems but the companies having disciplined practices and capable employees. The timeline used for preparing for inspections ensures making this work systematic and avoiding reactive approach to the preparation.
Regulatory References
1. FDA Investigations Operations Manual (IOM)https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspections/investigations-operations-manual
2. 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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