GLP Audits

Overview

Good Laboratory Practice (GLP) audits help ensure that laboratory studies are planned, performed, monitored, recorded, reported, and archived in a controlled and reliable manner.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent GLP audit and assessment services for testing laboratories, research facilities, contract laboratories, and other organizations performing regulated laboratory activities.

Our audits evaluate laboratory systems, study conduct, personnel responsibilities, equipment controls, documentation practices, computerized systems, data integrity, and quality-assurance oversight.

MGS uses a practical, risk-based approach to identify compliance gaps, strengthen laboratory controls, and support readiness for regulatory inspections and client audits.

Our GLP Audit Services

Laboratory System Audits

Assessment of laboratory organization, responsibilities, procedures, facilities, equipment, documentation, and quality-system controls.

Study-Based Audits

Review of selected studies to assess protocol compliance, raw data, calculations, documentation, reporting, and traceability.

Quality Assurance Unit Audits

Evaluation of QA independence, inspection programs, reporting processes, study oversight, and compliance-monitoring activities.

Equipment & Instrument Audits

Assessment of qualification, calibration, maintenance, usage logs, access controls, computerized interfaces, and lifecycle management.

Data Integrity Audits

Evaluation of paper and electronic records, audit trails, access controls, raw data, metadata, calculations, review practices, retention, backup, and archival.

Computerized Laboratory System Audits

Assessment of laboratory computerized systems for validation status, user management, data security, audit trails, electronic records, and applicable compliance controls.

Contract Laboratory Audits

Independent qualification and periodic assessment of outsourced testing laboratories and other laboratory service providers.

Pre-Inspection & Mock GLP Audits

Simulated regulatory inspections to identify potential compliance gaps and prepare laboratory teams for upcoming inspections.

Key GLP Audit Focus Areas

Depending on the audit scope, MGS may assess:

• Organization and personnel
• Roles and responsibilities
• Training and competency
• Quality Assurance Unit
• Standard operating procedures
• Study plans and protocols
• Study conduct
• Raw data management
• Test and reference items
• Reagents and standards
• Equipment qualification
• Calibration and maintenance
• Computerized systems
• Data integrity
• Laboratory worksheets and records
• Deviations and investigations
• Change control
• Sample management
• Method documentation
• Report preparation and approval
• Record retention
• Archiving
• Facility and environmental controls
• Vendor and service-provider oversight

Applicable GLP Perspective

Depending on the type of laboratory and regulatory market, audit criteria may consider applicable requirements and expectations associated with:

• OECD Principles of GLP
• Applicable national GLP requirements
• Regulatory expectations for non-clinical laboratory studies
• Data-integrity requirements
• Computerized-system and electronic-record controls
• Applicable client and study-specific requirements

The final audit scope and assessment criteria are defined according to the laboratory activities, study type, and regulatory environment.

Our Audit Process

• Define Scope

Understand the laboratory activities, study types, systems, regulatory requirements, and audit objectives.

• Prepare

Review available documentation and prepare a focused, risk-based audit plan.

• Conduct

Perform on-site or remote assessment through facility walkthroughs, interviews, document review, record verification, system review, and study-level assessment where applicable.

• Evaluate

Assess observations based on their potential impact on study reliability, data integrity, traceability, and regulatory compliance.

• Report

Provide a structured audit report with observations, evidence, compliance significance, and recommended improvement areas.

• Follow Up

Where required, support CAPA review, remediation planning, effectiveness checks, and follow-up assessments.

GLP Audit Deliverables

Depending on the agreed scope, MGS can provide:

• Audit agenda and audit plan
• Laboratory-system assessment
• Study-specific audit review
• Detailed GLP audit report
• Observation summary
• Risk-based observation classification
• Data-integrity gap assessment
• CAPA review support
• Inspection-readiness recommendations
• Follow-up audit support

Why Choose MGS for GLP Audits

Laboratory & Quality Expertise

Our audit approach combines laboratory, quality-system, validation, computerized-system, and data-integrity perspectives.

Risk-Based Assessment

Audit focus is directed toward areas with the greatest potential impact on data reliability, study integrity, and regulatory compliance.

Practical Findings

Observations are communicated clearly to help clients understand both the compliance gap and the required area of improvement.

Data Integrity Focus

Special attention is given to raw data, metadata, electronic records, audit trails, review controls, retention, and traceability.

Flexible Audit Scope

Audits can be designed for routine compliance review, contract-laboratory qualification, pre-inspection readiness, focused data-integrity assessment, or specific study/system evaluation.

Who We Audit

MGS can support GLP audits of:

• Analytical laboratories
• Testing laboratories
• Research facilities
• Contract laboratories
• Non-clinical study facilities
• Central laboratories
• Bioanalytical laboratories
• Computerized laboratory systems
• Laboratory equipment and service providers
• Other regulated laboratory operations