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GLP Compliance Audit Checklist for Pharmaceutical Laboratories

A comprehensive checklist for auditing compliance with Good Laboratory Practice (GLP) standards in pharmaceutical laboratories, covering all aspects of laboratory operations and management systems.

GLP Compliance Audit Checklist for Pharmaceutical Laboratories

by: audit-now
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About This Checklist

Ensuring compliance with Good Laboratory Practice (GLP) standards is crucial for pharmaceutical laboratories to maintain data integrity, quality, and regulatory compliance. This comprehensive GLP Compliance Audit Checklist is designed to help pharmaceutical companies assess their adherence to GLP principles, identify potential gaps, and implement corrective actions. By utilizing this checklist, organizations can streamline their audit processes, minimize risks, and enhance the overall quality of their laboratory operations.

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Industry

Healthcare

Standard

GLP - Good Laboratory Practice

Workspaces

Pharmaceutical Facilities

Occupations

Quality Assurance Specialist
Laboratory Manager
Regulatory Compliance Officer
Internal Auditor
GLP Compliance Manager
1
Is the laboratory compliant with Good Laboratory Practice (GLP)?
2
What is the adherence rate to standard operating procedures (SOPs) in the laboratory?
Min: 0
Target: 100
Max: 100
3
How would you rate the data integrity practices in the laboratory?
4
Please describe the current quality management system in place.
5
Is appropriate personal protective equipment being used in the laboratory?
6
What is the frequency of equipment calibration in the laboratory?
Min: 0
Target: 12
Max: 365
7
When was the last safety training conducted for laboratory staff?
8
Is emergency equipment (e.g., eyewash stations, fire extinguishers) easily accessible?
9
Are all laboratory records and documents complete and up to date?
10
Please describe the data retention policy in place for laboratory records.
11
How often are laboratory records audited for compliance?
Min: 1
Target: 6
Max: 12
12
Is access to electronic laboratory records secure and controlled?
13
Is all laboratory equipment properly maintained according to the schedule?
14
What is the due date for the next calibration of laboratory equipment?
Min: 0
Max: 365
15
When was the last calibration of the laboratory equipment performed?
16
Are calibration records readily available for inspection?
17
Are quality control procedures being followed as per the established guidelines?
18
Please provide an overview of the quality assurance program implemented in the laboratory.
19
How often are internal audits conducted to assess quality assurance practices?
Min: 1
Target: 4
Max: 12
20
Are corrective actions implemented in a timely manner following quality issues?

FAQs

The checklist covers essential GLP areas including personnel qualifications, facility management, equipment maintenance, standard operating procedures (SOPs), study protocols, data integrity, and quality assurance systems.

GLP compliance audits should be conducted at least annually, with more frequent audits recommended for high-risk areas or when significant changes occur in laboratory operations or personnel.

This checklist is designed for use by quality assurance personnel, laboratory managers, regulatory compliance officers, and internal auditors in pharmaceutical companies operating under GLP regulations.

Yes, the checklist can be tailored to address specific laboratory operations, study types, or regulatory requirements while maintaining core GLP principles.

By regularly using this checklist, laboratories can identify and address compliance issues proactively, maintain up-to-date documentation, and demonstrate a commitment to GLP principles, thus enhancing preparedness for regulatory inspections.

Benefits of GLP Compliance Audit Checklist for Pharmaceutical Laboratories

Ensures comprehensive coverage of GLP requirements

Facilitates consistent and standardized auditing processes

Helps identify and address compliance gaps efficiently

Supports continuous improvement in laboratory practices

Enhances regulatory readiness and reduces audit-related stress