New Facility Planning & Design

Overview

The success of a pharmaceutical facility depends heavily on decisions made during the early planning and design stages. Poor zoning, inefficient material flow, inadequate segregation, unsuitable utility capacity, or limited expansion flexibility can create long-term operational and compliance challenges.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, and other regulated organizations with new facility planning and design support from concept development through design review and implementation readiness.

Our approach integrates GMP requirements, process needs, personnel and material flow, contamination control, engineering systems, utilities, EHS, energy efficiency, validation considerations, and future expansion requirements into a coordinated facility concept.

MGS supports both new Greenfield projects and major facility redevelopment programs.

Our New Facility Planning & Design Services

Conceptual Facility Planning

Development of the overall facility concept based on product type, manufacturing process, capacity, regulatory markets, site constraints, and business objectives.

GMP Layout Development

Support for layout planning with consideration of zoning, segregation, process sequence, personnel flow, material movement, waste flow, and contamination-control requirements.

Process & Capacity Planning

Assessment of production requirements, batch sizes, equipment needs, process flow, and future capacity requirements.

Area Classification & Zoning

Support for defining classified, controlled, support, technical, and utility areas based on product and process requirements.

Personnel & Material Flow Planning

Design of practical and compliant movement pathways to reduce cross-flow, mix-up, contamination, and operational inefficiency.

Utility Requirement Planning

Identification and planning of critical utility requirements such as HVAC, water systems, steam, compressed air, gases, chilled water, and electrical systems.

Equipment Layout & Space Planning

Support for equipment positioning, maintenance access, material handling, cleaning access, ergonomic considerations, and operational flow.

Expansion & Future-Readiness Planning

Design considerations for future products, capacity expansion, technology upgrades, additional utilities, and operational flexibility.

High-Potency & Containment Planning

Specialized planning for products requiring segregation, containment, occupational exposure control, and enhanced contamination prevention.

Sustainable Facility Planning

Incorporation of energy efficiency, utility optimization, resource conservation, and green-building principles where appropriate.

Key Planning Considerations

Depending on the project, MGS may consider:

• Product type and dosage form
• Process flow
• Manufacturing capacity
• GMP zoning
• Personnel movement
• Material movement
• Waste movement
• Cross-contamination risks
• Segregation requirements
• Cleanroom classification
• HVAC zoning
• Utility capacity
• Equipment footprint
• Maintenance accessibility
• Cleaning requirements
• Warehouse requirements
• Laboratory support
• EHS requirements
• Fire and life safety
• Containment requirements
• Validation strategy
• Future expansion
• Energy efficiency
• Project cost and constructability

Regulatory & Design Perspective

Facility planning may consider applicable expectations associated with:

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

The final design basis should always be tailored to the client’s products, processes, target markets, and site-specific requirements.

Our Approach

• Understand the Requirement

Review the product portfolio, manufacturing process, target capacity, regulatory markets, site conditions, and business objectives.

• Develop the Design Basis

Define key process, facility, utility, quality, safety, and expansion requirements.

• Create the Facility Concept

Develop initial zoning, process flow, personnel flow, material flow, utility concepts, and space allocation.

• Review & Optimize

Evaluate the concept for GMP compliance, operational efficiency, contamination control, maintainability, constructability, and cost effectiveness.

• Coordinate Engineering Inputs

Align process, architectural, HVAC, utility, equipment, EHS, and validation requirements.

• Support Finalization

Support review and refinement of design documentation before detailed execution.

Deliverables

Depending on scope, MGS can provide:

• Facility planning concept
• GMP layout
• Zoning plan
• Personnel-flow diagram
• Material-flow diagram
• Waste-flow concept
• Process-flow review
• Area schedule
• Utility requirement assessment
• Equipment-layout review
• Design-basis document
• Facility compliance review
• Expansion strategy
• Containment planning support
• Sustainable design recommendations
• Design-review comments

Why Choose MGS

GMP-Focused Design

Facility concepts are developed with practical understanding of quality, compliance, contamination control, and validation requirements.

Multidisciplinary Expertise

MGS can integrate engineering, quality, validation, EHS, regulatory, energy, and operations perspectives.

Practical Facility Planning

Our focus is on facilities that are not only compliant, but also efficient, maintainable, scalable, and practical to operate.

Regulatory Perspective

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

High-Potency & Containment Capability

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

Future-Ready Design

Expansion, flexibility, utility capacity, automation, and future product requirements can be considered early in the design process.

Who We Support

MGS can support new facility planning and design for:

• API facilities
• Finished dosage form plants
• Sterile manufacturing facilities
• Oral solid dosage facilities
• Liquid and semi-solid facilities
• Biopharmaceutical facilities
• Medical-device manufacturing
• High-potency facilities
• Containment facilities
• Laboratories
• Warehouses
• Greenfield pharmaceutical projects
• Major brownfield redevelopment projects