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Pharmaceutical Equipment Validation Audit Checklist

A comprehensive audit checklist for evaluating pharmaceutical equipment validation practices, ensuring regulatory compliance, and maintaining consistent product quality through proper equipment qualification and monitoring.

Pharmaceutical Equipment Validation Audit Checklist
by: audit-now
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About This Checklist

Equipment validation is a critical process in the pharmaceutical industry to ensure that manufacturing equipment consistently produces products meeting predetermined specifications and quality attributes. This Equipment Validation Audit Checklist is designed to comprehensively assess the validation practices for pharmaceutical manufacturing equipment. By systematically evaluating installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and ongoing equipment monitoring, this checklist helps identify gaps in validation processes, ensures compliance with regulatory requirements, and maintains the highest standards of product quality and consistency in pharmaceutical manufacturing.

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Industry

Pharmaceuticals

Standard

EU GMP Annex 15, FDA 21 CFR Part 211, GAMP 5

Workspaces

Pharmaceutical manufacturing plants

Occupations

Validation Specialists
Quality Assurance Managers
Equipment Engineers
Process Engineers
Regulatory Compliance Officers

Equipment Validation Assessment

(0 / 5)

1
Is there a schedule for equipment revalidation?

Select the availability status of the revalidation schedule.

To ensure that the equipment is periodically revalidated to maintain compliance.
2
What is the score achieved during the Performance Qualification (PQ)?

Enter the performance qualification score.

To evaluate the effectiveness and efficiency of the equipment in performing its intended function.
Min: 1
Target: 5
Max: 5
3
Provide the results of the Operational Qualification (OQ).

Detail the results of the OQ.

To document and assess the performance of the equipment during the operational phase.
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4
Has the Installation Qualification (IQ) been completed for the equipment?

Indicate whether the Installation Qualification has been completed.

To verify that the equipment has been properly installed according to specifications.
5
Is the equipment compliant with GMP standards?

Select the compliance status of the equipment.

To ensure that the equipment meets the regulatory requirements for Good Manufacturing Practices.
6
Describe the maintenance history of the equipment.

Detail the maintenance activities performed on the equipment.

To provide insights into the upkeep and service history, helping to evaluate the equipment's reliability.
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7
What is the current operational status of the equipment?

Select the current status of the equipment.

To assess whether the equipment is operational, under maintenance, or decommissioned.
8
What is the expected lifespan of the equipment in years?

Enter the expected lifespan in years.

To understand the longevity and lifecycle planning for the equipment.
Min: 1
Target: 10
Max: 30
9
When was the last validation performed on the equipment?

Select the date of the last validation.

To track the frequency of validations and ensure compliance with validation protocols.
10
What is the identification number of the equipment being validated?

Enter the equipment identification number.

To uniquely identify the equipment for traceability and documentation purposes.
11
Provide a summary of recent changes made to the system.

Detail recent changes and their impact on the system.

To document any modifications and ensure that changes are controlled and validated.
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12
When was the last review of the computerized system conducted?

Select the date of the last review.

To maintain a schedule for regular reviews and ensure ongoing compliance.
13
How many users are currently authorized to access the system?

Enter the number of authorized users.

To assess the user base and ensure appropriate access controls are in place.
Min: 1
Target: 5
Max: 100
14
What is the current validation status of the computerized system?

Select the current validation status of the system.

To determine whether the system is validated, in the process of being validated, or not validated.
15
What is the name of the computerized system being validated?

Enter the name of the computerized system.

To establish a clear reference point for the system under evaluation.
16
Provide any observations related to the performance of the equipment during its operation.

Detail any observations about the equipment's performance.

To capture qualitative data on equipment performance that may not be reflected in quantitative metrics.
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17
When was the last maintenance performed on the equipment?

Select the date of the last maintenance.

To track maintenance history and ensure regular servicing of the equipment.
18
Does the equipment meet the performance compliance requirements?

Select whether the equipment meets performance compliance.

To ensure that the equipment operates within the defined performance parameters.
19
What is the maximum throughput capacity of the equipment (units per hour)?

Enter the maximum throughput capacity in units per hour.

To evaluate the efficiency and productivity of the equipment in a manufacturing setting.
Min: 1
Target: 100
Max: 500
20
What is the model number of the equipment?

Enter the model number of the equipment.

To identify the specific model for accurate performance tracking and analysis.
21
What mitigation strategies are in place to address identified risks?

Detail the mitigation strategies in place for this equipment.

To document the strategies that have been implemented to mitigate risks associated with the equipment.
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22
When is the next scheduled review for this risk assessment?

Select the date of the next review.

To ensure that risk assessments are reviewed regularly and updated as necessary.
23
What is the likelihood of equipment failure on a scale of 1 to 10?

Rate the likelihood of failure from 1 (very unlikely) to 10 (very likely).

To quantify the probability of failure, aiding in risk management and mitigation strategies.
Min: 1
Target: 5
Max: 10
24
What is the assessed risk level of using this equipment?

Select the assessed risk level of the equipment.

To evaluate the potential risk associated with the equipment and its operations.
25
What is the identifier for this risk assessment?

Enter the identifier for the risk assessment.

To uniquely identify the risk assessment for tracking and documentation purposes.

FAQs

The checklist covers Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and ongoing equipment performance monitoring and revalidation.

Full validation audits should be conducted during initial equipment installation and after major changes. Periodic reviews should be performed annually or based on equipment criticality and risk assessment.

The audit team should include validation specialists, quality assurance personnel, equipment engineers, and process experts familiar with the specific equipment and its intended use.

The checklist includes specific sections for validating computerized systems integrated with equipment, covering aspects such as software validation, data integrity, and electronic records compliance.

Yes, the checklist is designed to be adaptable for various types of equipment, including mixers, tablet presses, filling machines, and analytical instruments, while maintaining core validation principles.

Benefits

Ensures compliance with GMP regulations for equipment validation

Reduces the risk of equipment-related product quality issues

Optimizes equipment performance and reliability

Enhances documentation practices for equipment lifecycle management

Supports continuous improvement in validation processes