GMP Audits

Overview

Good Manufacturing Practice (GMP) audits are essential for evaluating whether pharmaceutical manufacturing operations, quality systems, facilities, laboratories, utilities, equipment, and supporting processes consistently meet applicable regulatory requirements.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent GMP audit services for pharmaceutical, API, finished dosage form, biopharmaceutical, and other regulated manufacturing organizations.

Our auditors assess both system-level and operational compliance to identify potential regulatory gaps, quality risks, documentation weaknesses, and areas requiring improvement.

MGS focuses on practical, risk-based findings that help organizations strengthen compliance, improve operational control, and maintain readiness for regulatory inspections and customer audits.

Our GMP Audit Services

Manufacturing Facility Audits

Assessment of manufacturing operations, production controls, process flow, material handling, segregation, line clearance, in-process controls, and overall GMP implementation.

Quality Management System Audits

Evaluation of quality-system elements including deviations, CAPA, change control, complaints, investigations, document control, training, management review, and quality risk management.

Quality Control Laboratory Audits

Review of laboratory practices, testing procedures, specifications, analytical documentation, equipment management, reference standards, reagents, data integrity, and laboratory controls.

Warehouse & Material Management Audits

Assessment of receipt, quarantine, sampling, approval, storage, dispensing, rejection, return, distribution, status identification, traceability, and material movement.

Engineering & Utility Audits

Review of HVAC, purified water, compressed air, steam, gases, electrical systems, maintenance programs, calibration, preventive maintenance, and engineering documentation.

Qualification & Validation Audits

Assessment of facility, utility, equipment, process, cleaning, and computerized-system qualification and validation activities across the lifecycle.

Data Integrity Audits

Evaluation of data governance, electronic and paper records, audit trails, access controls, data review, retention, backup, archival, and overall data-integrity practices.

Supplier & Contract Manufacturer GMP Audits

Independent assessment of suppliers, contract manufacturers, contract laboratories, and other external GxP partners to support qualification and ongoing oversight.

Pre-Inspection & Mock GMP Audits

Simulated regulatory inspections to identify potential compliance gaps and assess organizational readiness before an anticipated regulatory inspection.

Key GMP Audit Focus Areas

Depending on the scope of the audit, MGS may assess:

• Pharmaceutical Quality System
• Organization and personnel
• Training and competency
• Premises and facility design
• Personnel and material flow
• Equipment lifecycle management
• Utilities and support systems
• Manufacturing operations
• Packaging and labelling controls
• Raw and packaging material management
• Warehousing and distribution controls
• Laboratory controls
• Documentation and record management
• Deviation and investigation systems
• CAPA management
• Change control
• Quality risk management
• Complaints and recalls
• Supplier and vendor management
• Process validation
• Cleaning validation
• Computerized systems
• Data integrity
• Calibration and maintenance
• Environmental monitoring
• Contamination and cross-contamination control
• Self-inspection and internal audit systems
• Management oversight and quality metrics

Applicable GMP Perspective

Depending on the client’s products, facility, and target markets, audit criteria may consider applicable requirements and expectations associated with:

• US FDA
• EU GMP
• WHO GMP
• MHRA
• PIC/S
• TGA
• ANVISA
• ICH Guidelines
• Revised Schedule M
• Applicable national regulatory requirements

The final audit scope and criteria are defined according to the client’s regulatory market and operational requirements.

Our Audit Process

• Define Scope

Understand the facility, products, operations, applicable regulatory markets, previous inspection history, and audit objectives.

• Prepare

Review available documents and prepare a risk-based audit plan focusing on critical GMP systems and potential compliance risks.

• Conduct

Perform on-site or remote assessment through facility walkthroughs, interviews, document review, record verification, and evaluation of operational practices.

• Evaluate

Assess observations based on their potential impact on product quality, patient safety, data integrity, and regulatory compliance.

• Report

Provide a clear and structured audit report with observations, evidence, risk significance, and recommendations for improvement.

• Follow Up

Where required, support CAPA review, remediation planning, effectiveness verification, and follow-up assessment.

GMP Audit Deliverables

Depending on the agreed scope, MGS can provide:

• Audit agenda and assessment plan
• Opening and closing meeting support
• Detailed GMP audit report
• Observation summary
• Risk-based observation classification
• Compliance-gap assessment
• Recommended improvement areas
• CAPA review support
• Follow-up audit or effectiveness assessment

Why Choose MGS for GMP Audits

Experienced Audit Professionals

Our auditors bring practical experience across pharmaceutical quality, manufacturing, engineering, validation, laboratories, computerized systems, and regulatory compliance.

Risk-Based Audit Methodology

Audit activities focus on systems and controls with the greatest potential impact on product quality, patient safety, data integrity, and regulatory compliance.

Cross-Functional Assessment

MGS can evaluate GMP compliance from quality, engineering, validation, laboratory, manufacturing, and digital-system perspectives.

Practical Findings

Our audit reports are structured to clearly communicate the observed gap, its significance, and the area requiring corrective action or improvement.

Customized Audit Scope

Audits can be tailored for routine qualification, supplier oversight, pre-inspection preparation, compliance remediation, due diligence, or specific system assessment.

Remediation Support

Where required, MGS can support clients beyond the audit through CAPA review, remediation planning, documentation improvement, training, and follow-up assessment.

Who We Audit

MGS can support GMP audits of:

• API manufacturers
• Finished dosage form manufacturers
• Sterile manufacturing facilities
• Non-sterile manufacturing facilities
• Biopharmaceutical facilities
• Contract manufacturing organizations
• Contract testing laboratories
• Raw-material suppliers
• Packaging-material suppliers
• Warehouses and distribution facilities
• Engineering and utility systems
• Other critical GxP service providers