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ISO 17025 Compliance Checklist for Pharmaceutical Laboratories

A comprehensive checklist for auditing ISO 17025 compliance in pharmaceutical laboratories, covering management and technical requirements to ensure the quality and reliability of testing processes and results.

ISO 17025 Compliance Checklist for Pharmaceutical Laboratories

by: audit-now
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About This Checklist

Ensuring compliance with ISO 17025 is crucial for pharmaceutical laboratories to maintain the highest standards of quality and accuracy in testing. This comprehensive checklist is designed to help laboratory managers, quality assurance professionals, and auditors in the pharmaceutical industry evaluate and improve their laboratory's adherence to ISO 17025 requirements. By systematically addressing key areas such as personnel competence, equipment calibration, and quality management systems, this checklist helps identify gaps in compliance and streamline the audit process, ultimately enhancing the reliability and credibility of laboratory results.

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Industry

Healthcare

Standard

ISO/IEC 17025 - Testing Laboratory Competence

Workspaces

Pharmaceutical Facilities

Occupations

Laboratory Manager
Quality Assurance Specialist
Compliance Officer
Laboratory Technician
Internal Auditor
1
Is the laboratory's Quality Management System compliant with ISO 17025?

Select compliance status.

To ensure adherence to the standard's requirements for quality management.
2
Are all personnel competent and trained for their respective roles?

Indicate if personnel competence is verified.

To verify that personnel have the necessary skills and training.
3
What is the acceptable measurement uncertainty for the tests performed?

Enter measurement uncertainty in percentage.

To ensure measurement uncertainty is within acceptable limits for accuracy.
Min: 0
Target: 0.05
Max: 100
4
Is the test method validated according to ISO 17025?

Select validation status.

To confirm that test methods are validated to ensure reliability.
5
Provide records of equipment calibration.

Upload calibration records here.

To ensure all equipment is calibrated to maintain accuracy of results.
6
When was the last compliance audit conducted?

Select date of last audit.

To track the frequency of compliance audits.
7
Is the laboratory equipment calibrated according to the schedule?

Select calibration status.

To ensure all equipment is calibrated regularly to maintain accuracy.
8
Has the laboratory equipment undergone regular maintenance?

Indicate if maintenance is up to date.

To verify that equipment is maintained to ensure operational reliability.
9
What is the age of the laboratory equipment in years?

Enter age of equipment in years.

To assess whether the equipment is within a reasonable operational lifespan.
Min: 0
Target: 5
Max: 20
10
Is the equipment compliant with safety standards?

Select safety compliance status.

To ensure that laboratory equipment meets necessary safety regulations.
11
Provide maintenance logs for the equipment.

Upload maintenance logs here.

To ensure there is documentation of all maintenance performed.
12
When was the last calibration of the equipment performed?

Select the date of last calibration.

To track the recency of equipment calibration.
13
Are the quality control protocols being followed as per the standard operating procedures?

Select adherence status.

To ensure that quality control measures are effectively implemented.
14
Are control samples tested regularly as part of quality control?

Indicate if control sample testing is conducted.

To verify that control samples are included in testing to ensure accuracy.
15
How many quality control tests have been conducted in the last month?

Enter the number of tests conducted.

To assess the frequency of quality control testing.
Min: 0
Target: 30
Max: 100
16
What is the outcome of the most recent quality control test?

Select the result of the quality control test.

To evaluate the results of quality control measures.
17
Please provide documentation of the quality control tests performed.

Upload quality control documentation here.

To ensure there is proper documentation of quality control activities.
18
When was the last review of quality control procedures conducted?

Select the date of the last review.

To track the frequency of quality control reviews.
19
Are all personnel wearing the required personal protective equipment?

Select PPE compliance status.

To ensure that all staff adhere to safety protocols for personal protection.
20
Is emergency equipment (e.g., eyewash stations, safety showers) readily available?

Indicate if emergency equipment is available.

To verify that emergency safety equipment is accessible in case of an incident.
21
How many safety training sessions have been conducted in the past year?

Enter the number of safety training sessions.

To assess the commitment to safety training and education.
Min: 0
Target: 4
Max: 12
22
Is there a protocol for reporting safety incidents in place?

Select incident reporting protocol status.

To ensure that safety incidents are reported and addressed appropriately.
23
Provide documentation related to safety compliance measures.

Upload safety compliance documentation here.

To ensure that safety compliance is properly documented and verifiable.
24
When was the last safety audit conducted?

Select the date of the last safety audit.

To track the frequency of safety audits and ensure continuous improvement.
25
Are the environmental monitoring protocols being followed as required?

Select environmental monitoring compliance status.

To ensure adherence to established environmental monitoring standards.
26
Are environmental samples collected on a regular basis?

Indicate if regular sampling is conducted.

To confirm that sampling is performed consistently as part of monitoring efforts.
27
How many environmental samples were collected in the last quarter?

Enter the number of samples collected.

To assess the extent of environmental monitoring activities.
Min: 0
Target: 20
Max: 100
28
What is the outcome of the most recent environmental test?

Select the result of the environmental test.

To evaluate the results of environmental monitoring efforts.
29
Provide records of environmental monitoring activities.

Upload environmental monitoring records here.

To ensure there is documentation of environmental monitoring efforts.
30
When was the last environmental compliance audit conducted?

Select the date of the last environmental audit.

To track the frequency of environmental audits and ensure compliance.

FAQs

The checklist should be used at least annually for internal audits, and more frequently when implementing new processes or equipment, or in preparation for external accreditation audits.

Typically, the quality assurance manager or a designated internal auditor with thorough knowledge of ISO 17025 requirements and pharmaceutical laboratory operations should conduct the audit.

The checklist covers areas such as management requirements, technical competence, equipment calibration and maintenance, method validation, uncertainty of measurement, and quality control procedures specific to pharmaceutical testing.

By regularly using this checklist, laboratories can identify and address non-conformities, maintain up-to-date documentation, and ensure ongoing compliance with ISO 17025, making them better prepared for external accreditation audits.

Yes, while the core ISO 17025 requirements remain consistent, the checklist can be tailored to address specific testing methods, equipment, or regulatory requirements unique to different types of pharmaceutical laboratories, such as those focusing on drug development, quality control, or stability testing.

Benefits

Ensures comprehensive coverage of ISO 17025 requirements specific to pharmaceutical laboratories

Streamlines the audit process and improves efficiency in identifying non-conformities

Helps maintain consistent quality standards across all laboratory operations

Facilitates continuous improvement in laboratory practices and procedures

Enhances credibility and reliability of test results for regulatory compliance