Pharmaceutical Laboratory Equipment Calibration Audit Checklist

A comprehensive audit checklist for evaluating the calibration procedures, documentation, and compliance of laboratory equipment in pharmaceutical research and development facilities

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About This Checklist

Ensuring the accuracy and reliability of laboratory equipment is paramount in the pharmaceutical industry. This comprehensive calibration audit checklist is designed to verify that all critical laboratory instruments are properly calibrated, maintained, and documented in accordance with regulatory standards and good laboratory practices. By meticulously evaluating calibration procedures, documentation, and traceability, this checklist helps maintain the integrity of research data, ensure product quality, and support regulatory compliance. Regular calibration audits are essential for identifying potential issues, preventing measurement errors, and maintaining the highest standards of scientific rigor in pharmaceutical research and development.

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Industry

Healthcare

Standard

Laboratory Quality Standards

Workspaces

Distribution Centers

Occupations

Laboratory Managers
Quality Assurance Specialists
Metrologists
Calibration Technicians
Research Scientists
1
Is the laboratory equipment currently calibrated?
2
What is the due date for the next calibration?
Target: 2024-12-31
3
What method is used for calibration?
4
Is there documented traceability for the calibration?
5
What records are maintained for calibration?
6
Has the calibration verification been completed for all instruments?
7
What is the date of the last calibration performed?
Target: 2023-09-15
8
What is the frequency of calibration for the instruments?
9
What procedures are followed during calibration?
10
When is the next calibration due?
11
What is the identification number of the calibration equipment?
12
What is the current status of the calibration equipment?
13
What is the calibration tolerance level for the equipment?
Min: 0
Target: 0.01
Max: 0.1
14
What is the calibration history for this equipment?
15
What is the expiration date for the current calibration?
16
Is the calibration procedure documented and accessible?
17
Is the calibration process compliant with ISO/IEC 17025 and GLP?
18
What is the acceptable calibration error percentage?
Min: 0
Target: 0.5
Max: 1
19
What corrective actions have been taken for calibration discrepancies?
20
When was the last quality audit conducted related to calibration?
21
Is the calibration equipment qualified for use?
22
Has the initial qualification of the calibration equipment been completed?
23
When is the next review date for the equipment qualification?
24
What documents are available to support the equipment qualification?
25
What is the duration of the qualification period in months?
Min: 1
Target: 12
Max: 36

FAQs

The frequency of calibration audits can vary depending on the equipment type and usage, but generally, a comprehensive audit should be conducted at least annually, with more frequent checks for critical instruments.

Common equipment includes analytical balances, pH meters, spectrophotometers, chromatography systems (HPLC, GC), pipettes, thermometers, and incubators, among others specific to the laboratory's operations.

The audit should be conducted by qualified personnel, such as metrology specialists, quality assurance professionals, or trained laboratory managers. External calibration experts may also be involved for certain specialized equipment.

Key documentation includes calibration certificates, calibration procedures, equipment logbooks, maintenance records, out-of-specification investigations, and traceability records to national or international standards.

By systematically evaluating calibration practices, the checklist helps identify gaps in procedures, documentation deficiencies, and equipment issues. This leads to improved data reliability, enhanced regulatory compliance, and better overall laboratory performance.

Benefits of Pharmaceutical Laboratory Equipment Calibration Audit Checklist

Ensures compliance with regulatory requirements and good laboratory practices

Maintains the accuracy and reliability of critical laboratory equipment

Supports data integrity and the validity of research results

Helps prevent costly errors and product quality issues

Facilitates traceability and documentation for regulatory inspections