Single logo
LoginSign Up

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
4.7

Get Template

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.

Learn more

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?
2
Are all personnel competent and trained for their respective roles?
3
What is the acceptable measurement uncertainty for the tests performed?
Min: 0
Target: 0.05
Max: 100
4
Is the test method validated according to ISO 17025?
5
Provide records of equipment calibration.
6
When was the last compliance audit conducted?
7
Is the laboratory equipment calibrated according to the schedule?
8
Has the laboratory equipment undergone regular maintenance?
9
What is the age of the laboratory equipment in years?
Min: 0
Target: 5
Max: 20
10
Is the equipment compliant with safety standards?
11
Provide maintenance logs for the equipment.
12
When was the last calibration of the equipment performed?
13
Are the quality control protocols being followed as per the standard operating procedures?
14
Are control samples tested regularly as part of quality control?
15
How many quality control tests have been conducted in the last month?
Min: 0
Target: 30
Max: 100
16
What is the outcome of the most recent quality control test?
17
Please provide documentation of the quality control tests performed.
18
When was the last review of quality control procedures conducted?
19
Are all personnel wearing the required personal protective equipment?
20
Is emergency equipment (e.g., eyewash stations, safety showers) readily available?
21
How many safety training sessions have been conducted in the past year?
Min: 0
Target: 4
Max: 12
22
Is there a protocol for reporting safety incidents in place?
23
Provide documentation related to safety compliance measures.
24
When was the last safety audit conducted?
25
Are the environmental monitoring protocols being followed as required?
26
Are environmental samples collected on a regular basis?
27
How many environmental samples were collected in the last quarter?
Min: 0
Target: 20
Max: 100
28
What is the outcome of the most recent environmental test?
29
Provide records of environmental monitoring activities.
30
When was the last environmental compliance audit conducted?

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 of ISO 17025 Compliance Checklist for Pharmaceutical Laboratories

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