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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

Pharmaceutical Laboratory Equipment Calibration Audit Checklist
by: audit-now
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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

Pharmaceuticals

Standard

ISO/IEC 17025, Good Laboratory Practice (GLP)

Workspaces

Distribution centers

Occupations

Laboratory Managers
Quality Assurance Specialists
Metrologists
Calibration Technicians
Research Scientists

Laboratory Equipment Calibration

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1
What records are maintained for calibration?

Provide details of calibration records maintained.

To assess data integrity and compliance with GLP.
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2
Is there documented traceability for the calibration?

Select the traceability status.

To confirm that the calibration process follows traceability standards.
3
What method is used for calibration?

Describe the calibration method used.

To ensure proper calibration techniques are employed.
4
What is the due date for the next calibration?

Enter the next calibration due date.

To track when the next calibration is needed to maintain compliance.
Target: 2024-12-31
5
Is the laboratory equipment currently calibrated?

Select the current calibration status.

To ensure that all equipment meets calibration requirements.
6
When is the next calibration due?

Enter the due date for the next calibration.

To track upcoming calibration dates and maintain compliance.
7
What procedures are followed during calibration?

Describe the calibration procedures used.

To ensure that proper calibration methodologies are adhered to.
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8
What is the frequency of calibration for the instruments?

Select the calibration frequency.

To ensure calibration is performed at appropriate intervals.
9
What is the date of the last calibration performed?

Enter the date of the last calibration.

To ensure timely calibration and compliance with standards.
Target: 2023-09-15
10
Has the calibration verification been completed for all instruments?

Indicate whether calibration verification is complete.

To confirm that all instruments have undergone necessary verification procedures.
11
What is the expiration date for the current calibration?

Enter the calibration expiration date.

To ensure that calibrations are kept up to date and compliant.
12
What is the calibration history for this equipment?

Provide details of the calibration history.

To maintain records of past calibrations for compliance and traceability.
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13
What is the calibration tolerance level for the equipment?

Enter the calibration tolerance level.

To ensure the equipment operates within specified tolerances.
Min: 0
Target: 0.01
Max: 0.1
14
What is the current status of the calibration equipment?

Select the current status of the equipment.

To assess if the equipment is operational and available for use.
15
What is the identification number of the calibration equipment?

Enter the calibration equipment ID.

To ensure each piece of equipment can be tracked and managed effectively.
16
When was the last quality audit conducted related to calibration?

Enter the date of the last quality audit.

To track the frequency of quality audits for compliance monitoring.
17
What corrective actions have been taken for calibration discrepancies?

Provide details of corrective actions taken.

To ensure that any issues are addressed promptly to maintain quality.
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18
What is the acceptable calibration error percentage?

Enter the acceptable calibration error percentage.

To establish acceptable limits for calibration accuracy.
Min: 0
Target: 0.5
Max: 1
19
Is the calibration process compliant with ISO/IEC 17025 and GLP?

Select the compliance status.

To confirm adherence to industry standards for calibration.
20
Is the calibration procedure documented and accessible?

Indicate whether the calibration procedure is documented.

To ensure that all calibration procedures are properly documented for compliance.
21
What is the duration of the qualification period in months?

Enter the qualification duration in months.

To determine how long the qualification remains valid.
Min: 1
Target: 12
Max: 36
22
What documents are available to support the equipment qualification?

Describe the documents available for equipment qualification.

To verify that proper documentation exists for qualifications.
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23
When is the next review date for the equipment qualification?

Enter the next review date for the qualification.

To ensure regular reviews are conducted to maintain qualification status.
24
Has the initial qualification of the calibration equipment been completed?

Indicate whether the initial qualification is complete.

To confirm that the equipment has undergone initial qualification.
25
Is the calibration equipment qualified for use?

Select the qualification status of the equipment.

To ensure that all equipment used for calibration meets qualification criteria.

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

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