Our GEP Auditing Services

Good Engineering Practice provides the technical foundation on which GMP compliance is built. If your facility, utilities, and equipment are not properly designed, installed, commissioned, qualified, and maintained, no amount of documentation will make your products safe and effective. GEP covers the entire equipment layout, design, construction, commissioning and maintenance. GEP-compliant equipment is a prerequisite for GMP, but it does not replace GMP. Only equipment that meets GEP principles makes GMP possible. GxP Cellators provides GEP auditing services for pharmaceutical, biotech, and medical device facilities.

Global Regulatory Frameworks for GEP

ISPE Good Practice Guides

The International Society for Pharmaceutical Engineering publishes baseline guides that provide best practice for engineering systems. The ISPE HVAC Guide, Second Edition, published in September 2024, covers GMP and GEP blend for HVAC design. It addresses sustainability, economics, and environmental health. Topics include design criteria, system configurations, controls, and commissioning.

Summary of Key ISPE Requirements:

ISPE publishes baseline guides for engineering systems
ISPE HVAC Guide Second Edition published September 2024
Covers GMP and GEP blend for HVAC design
Addresses sustainability and economics
Addresses environmental health
Topics include design criteria
Topics include system configurations
Topics include controls and commissioning

GAMP 5

GAMP 5 provides a risk based approach to compliant GxP computerized systems that is widely used in the industry. The guide helps organizations validate systems in a way that is proportionate to risk and compliant with regulatory expectations.

Summary of Key GAMP 5 Requirements:

Risk based approach to compliant GxP systems
Widely used in industry
Helps validate systems proportionate to risk
Compliant with regulatory expectations

EU GMP Annex 15

EU GMP Annex 15 covers Qualification and validation and has been in operation since October 2015. This annex provides requirements for design qualification, installation qualification, operational qualification, and performance qualification.

Summary of Key EU GMP Annex 15 Requirements:

Qualification and validation requirements
In operation since October 2015
Design qualification requirements
Installation qualification requirements
Operational qualification requirements
Performance qualification requirements

FDA Requirements for Engineering Systems

The FDA requires that equipment be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Appropriate controls must be exercised over computer systems to assure that changes in master production records are instituted only by authorized personnel. Input to and output from computer systems must be checked for accuracy, with the degree and frequency of verification based on system complexity and reliability.

Summary of Key FDA Requirements:

Equipment routinely calibrated and inspected
Written program for proper performance
Controls over computer systems
Changes only by authorized personnel
Input and output checked for accuracy
Verification based on complexity and reliability

Health Canada Requirements for Engineering Systems

Health Canada GMP requirements address premises, equipment, and utilities. Equipment must be designed, installed, and maintained to prevent contamination and ensure product quality. Utilities such as water, steam, and air must be qualified and monitored.

Summary of Key Health Canada Requirements:

Premises, equipment, and utilities addressed
Equipment designed to prevent contamination
Equipment installed to prevent contamination
Equipment maintained to prevent contamination
Utilities qualified and monitored

MHRA Requirements for Engineering Systems

The MHRA enforces engineering requirements through GMP inspections. Common findings include inadequate qualification of utilities, insufficient maintenance, and inadequate calibration programs.

Summary of Key MHRA Requirements:

Engineering requirements enforced through inspections
Common findings include inadequate qualification
Insufficient maintenance identified
Inadequate calibration programs identified

WHO Requirements for Engineering Systems

The WHO GMP guidelines include requirements for premises, equipment, and utilities. The WHO has published guidelines on heating, ventilation and air conditioning systems for non sterile pharmaceutical products in two parts.

Summary of Key WHO Requirements:

Premises, equipment, and utilities addressed
HVAC guidelines for non sterile products
Published in two parts

Audit Types We Provide

Facility Design and Construction Audits

We audit facility design and construction to verify that facilities meet GMP requirements. This includes layout, flow, segregation, cleanroom classification, and finishes. We review design documentation, construction records, and as built drawings.

Summary of Facility Design and Construction Audits:

Verify facilities meet GMP requirements
Review layout, flow, and segregation
Review cleanroom classification
Review finishes
Review design documentation
Review construction records
Review as built drawings

Cleanroom and HVAC System Audits

HVAC systems are critical to contamination control. We audit HVAC design, installation, and performance, including air handling units, filters, ductwork, and terminal units. We review air flow patterns, pressure differentials, temperature and humidity control, and environmental monitoring.

Summary of Cleanroom and HVAC System Audits:

HVAC critical to contamination control
Audit design, installation, and performance
Review air handling units
Review filters and ductwork
Review terminal units
Review air flow patterns
Review pressure differentials
Review temperature and humidity control
Review environmental monitoring

Water System Audits

Water systems are critical utilities in pharmaceutical manufacturing. We audit purified water, water for injection, and clean steam systems. Our reviews cover design, installation, qualification, monitoring, and maintenance. We review sanitization procedures, sampling plans, and trending data.

Summary of Water System Audits:

Water systems critical utilities
Audit purified water systems
Audit water for injection systems
Audit clean steam systems
Review design and installation
Review qualification and monitoring
Review maintenance
Review sanitization procedures
Review sampling plans and trending

Compressed Air and Process Gas Audits

Compressed air and process gases can contact products directly. We audit generation, distribution, and monitoring systems. We review quality standards, testing, and maintenance.

Summary of Compressed Air and Process Gas Audits:

Compressed air can contact products
Process gases can contact products
Audit generation systems
Audit distribution systems
Audit monitoring systems
Review quality standards
Review testing and maintenance

Process Equipment Audits

Process equipment must be properly designed, installed, qualified, and maintained. We audit reactors, mixers, dryers, mills, tablet presses, filling machines, and packaging equipment. We review design qualification, installation qualification, operational qualification, and performance qualification.

Summary of Process Equipment Audits:

Equipment designed, installed, qualified, maintained
Audit reactors, mixers, dryers
Audit mills, tablet presses
Audit filling machines
Audit packaging equipment
Review DQ, IQ, OQ, PQ

Qualification and Validation Audits

Qualification and validation are core GEP activities. We audit your qualification master plan, protocols, and reports. We review design qualification, installation qualification, operational qualification, and performance qualification for facilities, utilities, and equipment.

Summary of Qualification and Validation Audits:

Core GEP activities
Audit qualification master plan
Audit protocols and reports
Review DQ, IQ, OQ, PQ
For facilities, utilities, and equipment

Commissioning Audits

Commissioning is the process of verifying that systems are installed and operate according to design specifications. We audit commissioning plans, protocols, and reports.

Summary of Commissioning Audits:

Verify systems installed according to design
Verify systems operate according to design
Audit commissioning plans
Audit commissioning protocols
Audit commissioning reports

Maintenance and Calibration Audits

Maintenance and calibration programs ensure that equipment continues to operate correctly. We audit maintenance procedures, schedules, records, and spare parts management. We review calibration procedures, standards, schedules, and records.

Summary of Maintenance and Calibration Audits:

Ensure equipment operates correctly
Audit maintenance procedures
Audit maintenance schedules
Audit maintenance records
Audit spare parts management
Review calibration procedures
Review calibration standards
Review calibration schedules

Engineering Change Control Audits

Engineering changes must be properly controlled to prevent unintended impacts. We audit change control procedures for engineering systems, including impact assessment, approval, implementation, and verification.

Summary of Engineering Change Control Audits:

Changes properly controlled
Prevent unintended impacts
Audit change control procedures
Review impact assessment
Review approval and implementation
Review verification

Automation and Control System Audits

Automation and control systems require validation and data integrity controls. We audit PLC, SCADA, DCS, and HMI systems. We review system architecture, access controls, audit trails, and backup procedures.

Summary of Automation and Control System Audits:

Automation requires validation
Data integrity controls required
Audit PLC, SCADA, DCS, HMI
Review system architecture
Review access controls
Review audit trails
Review backup procedures

Who We Work With and Our Partners

Clients We Serve

We serve pharmaceutical manufacturers, biotechnology companies, medical device manufacturers, contract manufacturing organizations, engineering firms, construction companies, equipment vendors, utility providers, facility management companies, and commissioning agents.

Summary of Clients We Serve:

Pharmaceutical manufacturers
Biotechnology companies
Medical device manufacturers
Contract manufacturing organizations
Engineering firms
Construction companies
Equipment vendors
Utility providers
Facility management companies
Commissioning agents

Our Partners

We collaborate with engineering associations, equipment vendors, automation vendors, calibration providers, training providers, and regulatory consultants.

Summary of Our Partners:

Engineering associations
Equipment vendors
Automation vendors
Calibration providers
Training providers
Regulatory consultants

Our GEP Audit Process

Phase	Activities	Output
Planning	Scope, systems, standards, document request	Audit plan
Document review	Design docs, qualification reports, maintenance records	Pre audit analysis
On site	System walkdown, interviews, record review	Working notes
Testing review	Qualification protocols, test results, deviations	Findings
Close out	Classification and CAPA discussion	Draft findings
Report	Final report with prioritized actions	Audit report
Follow up	CAPA verification and closure	Closure letter

Summary of GEP Audit Process:

Planning: scope, systems, standards
Document review: design, qualification, maintenance
On site: system walkdown, interviews
Testing review: protocols, results, deviations
Close out: classification and CAPA
Report: final report with prioritized actions
Follow up: CAPA verification and closure

Why Choose GxP Cellators for GEP Auditing

Auditors with engineering and qualification experience
Coverage of FDA, EMA, Health Canada, MHRA, WHO, ISPE, and GAMP frameworks
Strong focus on qualification, commissioning, and maintenance
Practical support for engineering change control
Reports designed for engineering and quality teams
Full confidentiality for technical and commercial information

Summary of Why Choose GxP Cellators:

Auditors with engineering experience
Coverage of FDA, EMA, Health Canada, MHRA, WHO
Coverage of ISPE and GAMP frameworks
Strong focus on qualification and commissioning
Practical support for change control
Reports for engineering and quality teams
Full confidentiality

Contact Us for GEP Auditing Support

If you need to qualify a facility, assess an engineering system, or verify your maintenance program, our GEP auditing team can help. Contact us to discuss your engineering systems.

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Source: GxP Cellators GxP Auditing page