Validation tests do not finish once the testing phase has been accomplished. A good validation report proves the outcome of the validation process and contains information about what was tested, the method applied for conducting tests, the results obtained and difficulties faced during the tests. The validation report provides written evidence that a facility, a system, equipment, utility, process or analytical procedure is utilized in accordance with given acceptance criteria.
Validation reports are among the first pieces of documentation that may be required by inspectors during validation inspections as they summarize all validation experiences. Inspectors depend on those reports because they allow them to determine if a validation study was designed scientifically, conducted according to the protocols approved by the governing authority and analyzed objectively before giving approval. A badly written report can cast a shadow on a successful validation study.
In my experience, many validation reports are unnecessarily long because they re-do what the protocol states or contain too much of raw data. A good validation report should present a complete technical picture while being apt, logical and supported by objective evidence.
The validation protocol describes how the validation will be performed, while the validation report reveals how the validation process has been carried out and whether it has met its objectives successfully. Validation reports can be issued for such procedures as:
An effectively prepared report can:
Normal information found on the title page includes:
Example:
"The objective of this report is to present and analyze the results of the Performance Qualification of the purified water generation and distribution system and to determine if it is capable of producing water that meets set quality standards."
The objective should be in accordance with the approved protocol.
If applicable, e.g.:
Include information on:
Every test should have:
Instead of dumping the full raw data sheets into report, summarize information in tables while referring to the initial data.
Well-organized tables improve readability during inspections.
Each deviation must contain:
"No impact on validation."
Instead, clarify how the deviation influenced validation based on technical evidence.
For example:
It is useful to organize the evaluation result in the form of a table.
This enables quick verification of compliance by reviewers/ inspectors.
Do not simply write:
“Validation Passed”
Instead provide a technical conclusion addressing the purpose of the validation.
For example:
“Based on successful completion of all the tests defined in the protocol, acceptable analytical results and corrected deviations, the purified water system has proven consistent performance and qualifies for routine pharmaceutical use.”
The final conclusion should also describe limitations, suggestions or requirements for monitoring continuance.
Examples of the majority of reviewers are:
From my experience, some of the best validation reports are those that are not lengthy, scientifically sound and are well substantiated with documents. Instead of impressing reviewers with tons of information, those papers provide logical information, explain technical decisions made and inspire trust that the validated procedure/equipment/system will be able to work properly in the future.
In my experience, many validation reports are unnecessarily long because they re-do what the protocol states or contain too much of raw data. A good validation report should present a complete technical picture while being apt, logical and supported by objective evidence.
What is Validation Report?
A validation report is a regulated GMP document summarizing the conduction and results of a validation experiment. It compares the actual data to the expected acceptance criteria determined in the approved validation protocol and reaches a conclusion about the validity of the validated system.The validation protocol describes how the validation will be performed, while the validation report reveals how the validation process has been carried out and whether it has met its objectives successfully. Validation reports can be issued for such procedures as:
- Equipment Qualification (IQ, OQ, PQ)
- Process Validation
- Cleaning Validation
- Utility Validation
- HVAC Qualification
- Water System Validation
- Computer System Validation
- Analytical Method Validation
- Sterilization Validation
- Packaging Process Validation
Significance of Validation Reports
Validation reports give proof of compliance with regulations and habitual production processes.An effectively prepared report can:
- Prove compliance with GMP regulations
- Confirm completion of validation process
- Help in decision making regarding product authorizations
- Provide means of traceability for the forthcoming audits
- Assist in the process of regular assessment and revalidation
- Represent historical evidence of changes and investigations
Key Elements of a Validation Report
Although formats vary from company to company, there are common sections found in validation reports of most pharmaceutical companies:1. Title page
The title page should specify the validation activity and information related to document control.Normal information found on the title page includes:
- Title of the report
- Name of equipment or system
- Document number
- Revision number
- Reference of validation protocol
- Prepared by
- Reviewed by
- Approved by
- Dates of approval
2. Objective
This section quickly describes the reason for the study that has been conducted.Example:
"The objective of this report is to present and analyze the results of the Performance Qualification of the purified water generation and distribution system and to determine if it is capable of producing water that meets set quality standards."
The objective should be in accordance with the approved protocol.
3. Scope
Scope refers to limitations on the validation process. In the scope one should mention:- Equipment or system which is included in the scope
- Production area
- Product or process
- Stage of validation
- Exclusions, if any
4. Reference Documents
This section should contain a list of all documents related to validation. For example:- Validation Protocol
- Validation Master Plan (VMP)
- Standard Operating Procedures
- User Requirement Specification (URS)
- Functional Specification
- Design Specification
- Calibration Certificates
- Regulatory Guidelines
5. Description of System
State the summary about equipment, process or utilities which are being validated.If applicable, e.g.:
- Manufacturer
- Model
- Equipment identification
- Capacity
- Location
- Operating principle
- Components involved
6. Summary of Validation Execution
This section will provide details related to how the tests were conducted.Include information on:
- Test date
- Status of validation phases
- Number of validation runs
- Employers engaged
- Products assessed
- Sampling sites
- Environmental conditions, if any
7. Testing Results
This is important part of the verification report.Every test should have:
- Test description
- Criteria for acceptance
- Real results
- Result of pass or fail
- Additional information
Instead of dumping the full raw data sheets into report, summarize information in tables while referring to the initial data.
| Test | Acceptance Criteria | Result | Status |
| Temperature Mapping | ±2°C | Complied | Pass |
| Pressure Differential | ≥15 Pa | 18–21 Pa | Pass |
| Conductivity | ≤1.3 µS/cm | 0.95 µS/cm | Pass |
Management of Deviations in Validation
Validation studies rarely take place without having any deviations taking place. The report must show a complete record of every deviation regardless whether that was significant to the result of the study.Each deviation must contain:
- Deviation number
- Deviation description
- Root cause
- Impact of a deviation
- Corrective action
- Preventive action
- Final disposition
"No impact on validation."
Instead, clarify how the deviation influenced validation based on technical evidence.
Statistical Evaluation
If applicable, use statistical analysis to illustrate the consistency of the process.For example:
- Mean
- Standard deviation
- Relative Standard Deviation (RSD)
- Capabilities of the process (Cp/Cpk)
- Trend analysis
- Confidence intervals
Acceptance Criteria Review
The evaluation should determine whether all acceptance criteria set prior to the study were achieved.It is useful to organize the evaluation result in the form of a table.
| Parameter | Acceptance Criteria | Result | Conclusion |
| Installation | Complete | Achieved | Acceptable |
| Operational Tests | All Pass | Passed | Acceptable |
| Performance Tests | Meets Specifications | Complied | Acceptable |
Final Conclusion
The conclusion is an important part of the report.Do not simply write:
“Validation Passed”
Instead provide a technical conclusion addressing the purpose of the validation.
For example:
“Based on successful completion of all the tests defined in the protocol, acceptable analytical results and corrected deviations, the purified water system has proven consistent performance and qualifies for routine pharmaceutical use.”
The final conclusion should also describe limitations, suggestions or requirements for monitoring continuance.
Evaluation and Acceptance
Before the approval of validation reports, they must be checked by an independent entity.Examples of the majority of reviewers are:
- Validation Department
- Quality Assurance
- Production
- Engineering
- Quality Control
- Data accuracy
- Traceability
- Calculation correctness
- Deviation assessment
- Conclusion validity
Common Failures Found in Inspections
Regulatory inspectors often find shortcomings in validation reports such as:- Results not supported by data
- Missing assessments of deviations
- Calculation errors
- Incomplete traceability to the protocol
- Acceptance criteria that have been changed after execution
- Missing raw data references
- Equipment identifications inconsistent
- Insufficient statistical analysis
- Reports that are approved before deviations have been documented
- Copying results from previous reports without justification
Best Practices for Preparing Validation Reports
To improve the quality of validation reports organizations should comply with the following:- Prepare the report immediately after research
- Compare the results with acceptance criteria
- Report only relevant summarized information
- Present the deviations objectively
- Use tables for better readability
- Make sure conclusions are supported by evidence
- Conduct independent technical review and quality system review
- Use the same terms through the text
- Check all calculations before issuing the report
- Make sure the report is linked to the changes control and program review
From my experience, some of the best validation reports are those that are not lengthy, scientifically sound and are well substantiated with documents. Instead of impressing reviewers with tons of information, those papers provide logical information, explain technical decisions made and inspire trust that the validated procedure/equipment/system will be able to work properly in the future.
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