Pharmaceutical Engineering & Facility Solutions

Key Engineering & Facility Challenges

Organizations may face challenges such as:

• Designing layouts that support GMP-compliant personnel and material flow
• Preventing cross-contamination and mix-ups
• Balancing compliance requirements with operational efficiency
• Integrating process, utility, HVAC, and equipment requirements
• Managing greenfield and brownfield project risks
• Selecting suitable equipment and vendors
• Controlling project cost, schedule, and technical scope
• Designing for future expansion and flexibility
• Meeting high-potency or containment requirements
• Maintaining alignment between engineering design and qualification needs
• Improving energy performance without compromising GMP controls
• Upgrading legacy facilities to current regulatory expectations

Regulatory & Design Perspective

Depending on project scope and target markets, MGS facility and engineering support may consider applicable requirements and expectations associated with:

• US FDA
• MHRA
• WHO GMP
• EU GMP
• PIC/S
• TGA
• ANVISA
• Revised Schedule M
• Applicable cleanroom and engineering standards
• Relevant contamination-control and validation expectations
• Other applicable national and international requirements

 Our Engineering Approach

• Understand

Define the product, process, capacity, facility, regulatory market, operational requirements, and project objectives.

• Assess

Review site conditions, existing systems, project constraints, compliance requirements, and key technical risks.

• Conceptualize

Develop practical concepts for layout, flow, utilities, HVAC, process integration, equipment, and project execution.

• Design & Evaluate

Support development and review of engineering documentation, specifications, layouts, technical packages, and vendor proposals.

• Implement

Support construction, installation, coordination, technical clarification, procurement interfaces, and project monitoring.

• Verify

Coordinate with qualification and validation activities to confirm that facilities, utilities, and equipment are installed and perform as intended.

• Prepare for Operation

Support handover, documentation completion, training, readiness review, and transition to routine operation.

Engineering Deliverables

Depending on scope, MGS can provide:

• Facility planning concepts
• GMP layout review
• Process and utility requirement assessments
• Engineering design review
• HVAC and cleanroom assessment
• Equipment technical specifications
• Vendor technical evaluations
• Tender and procurement support
• Project schedules and trackers
• Risk assessments
• Facility compliance reports
• Containment strategy support
• Energy optimization recommendations
• Project-management support
• Qualification-interface support

 What Sets MGS Apart

Pharmaceutical Engineering & GMP Integration

MGS combines technical engineering knowledge with practical understanding of GMP, validation, contamination control, and regulatory expectations.

Multidisciplinary Expertise

Our projects can draw on engineering, quality, validation, EHS, energy, regulatory, and operations expertise.

Facility Design Experience

MGS supports facility planning and design with consideration of expectations associated with US FDA, MHRA, WHO GMP, TGA, ANVISA, Revised Schedule M, and other applicable requirements.

High-Potency & Containment Expertise

Specialized support is available for facilities requiring enhanced segregation, containment, exposure control, and contamination prevention.

Practical & Cost-Conscious Solutions

Engineering recommendations are developed with consideration of compliance, operability, maintainability, project economics, and long-term sustainability.

Green & Sustainable Design

Energy efficiency, utility optimization, and sustainable engineering principles can be integrated into facility planning.

End-to-End Support

MGS can support projects from early concept and design review through implementation, qualification interface, and operational readiness.

Who We Support

MGS Pharmaceutical Engineering & Facility Solutions can support:

• Pharmaceutical manufacturing facilities
• API and intermediate plants
• Finished dosage form facilities
• Sterile manufacturing facilities
• Biopharmaceutical facilities
• Medical-device manufacturing sites
• Laboratories
• Warehouses
• High-potency and containment facilities
• Greenfield projects
• Brownfield expansion projects
• Existing facilities undergoing upgrade or remediation