GLP Compliance Audit Checklist for Pharmaceutical Laboratories

Laboratory Compliance Assessment

(0 / 4)

Please describe the current quality management system in place.

Provide a detailed description.

To understand the structure and effectiveness of the quality management system.

How would you rate the data integrity practices in the laboratory?

Select the appropriate rating.

To assess the reliability and accuracy of data management.

What is the adherence rate to standard operating procedures (SOPs) in the laboratory?

Provide the adherence rate as a percentage.

To evaluate the effectiveness of SOP implementation.

Min: 0

Target: 100

Max: 100

Is the laboratory compliant with Good Laboratory Practice (GLP)?

Select the current compliance status.

To determine adherence to regulatory standards for laboratory practices.

Laboratory Safety and Compliance Review

(0 / 4)

Is emergency equipment (e.g., eyewash stations, fire extinguishers) easily accessible?

Select the accessibility status of emergency equipment.

To verify that emergency safety measures are readily available in case of an incident.

When was the last safety training conducted for laboratory staff?

Select the date of the last training.

To ensure that all staff are up to date with safety training protocols.

What is the frequency of equipment calibration in the laboratory?

Provide the number of calibrations conducted per year.

To assess compliance with calibration standards and ensure accurate results.

Min: 0

Target: 12

Max: 365

Is appropriate personal protective equipment being used in the laboratory?

Select the usage status of PPE.

To ensure that safety measures are in place to protect laboratory personnel.

Laboratory Documentation and Record Keeping Audit

(0 / 4)

Is access to electronic laboratory records secure and controlled?

Select the security status of electronic records.

To verify the security measures in place for protecting sensitive laboratory data.

How often are laboratory records audited for compliance?

Provide the number of audits conducted per year.

To evaluate the frequency of audits to ensure ongoing compliance with standards.

Min: 1

Target: 6

Max: 12

Please describe the data retention policy in place for laboratory records.

Provide a detailed description of the policy.

To assess the adequacy of the data retention policy in accordance with regulatory requirements.

Are all laboratory records and documents complete and up to date?

Select the completeness status of documentation.

To ensure that all necessary documentation is properly maintained for compliance.

Laboratory Equipment Maintenance and Calibration Audit

(0 / 4)

Are calibration records readily available for inspection?

Select the availability status of calibration records.

To confirm that documentation for equipment calibration is accessible and organized.

When was the last calibration of the laboratory equipment performed?

Select the date of the last calibration.

To verify compliance with calibration standards and timelines.

What is the due date for the next calibration of laboratory equipment?

Provide the next calibration due date.

To ensure that equipment calibration is performed on time.

Min: 0

Max: 365

Is all laboratory equipment properly maintained according to the schedule?

Select the maintenance status of the equipment.

To ensure that equipment is functioning correctly and safely.

Laboratory Quality Assurance Review

(0 / 4)

Are corrective actions implemented in a timely manner following quality issues?

Select the implementation status of corrective actions.

To ensure that necessary actions are taken to address quality concerns promptly.

How often are internal audits conducted to assess quality assurance practices?

Provide the number of internal audits conducted per year.

To determine the regularity of internal audits for maintaining quality standards.

Min: 1

Target: 4

Max: 12

Please provide an overview of the quality assurance program implemented in the laboratory.

Provide a detailed overview of the QA program.

To evaluate the effectiveness and structure of the quality assurance initiatives.

Are quality control procedures being followed as per the established guidelines?

Select the adherence status to quality control procedures.

To assess compliance with quality control protocols that ensure reliable results.

FAQs

What are the key areas covered in this GLP Compliance Audit Checklist?

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.

How often should a GLP compliance audit be conducted?

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.

Who should use this GLP Compliance Audit Checklist?

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.

Can this checklist be customized for specific laboratory operations?

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

How does this checklist help in preparing for regulatory inspections?

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

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