Project Planning

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PHARMACEUTICAL MANUFACTURING LAYOUT DESIGNS

Designing a pharmaceutical manufacturing layout involves a systematic approach to ensure that the facility meets regulatory requirements, supports efficient production processes, and maintains product quality.

Planning a green field / Brown Filed project?

you can engage us for:

Project Planning and Scope Definition
  • Establish the scope, goals, Define the product types, production capacity, and operational requirements.
  • Establish compliance (e.g., FDA, EMA, WHO GMP).
  • Develop a project timeline, budget, and resource allocation plan.
  • Identify key stakeholders, including engineering, quality assurance, regulatory, and operations teams.
Site Selection and Analysis
  • Map out each stage of the manufacturing process, including material handling, storage, production, packaging, and waste management.
  • Identify critical control points and areas requiring stringent environmental controls (e.g., cleanrooms, sterile areas).
  • Ensure a logical and efficient flow of materials, personnel, and products to minimize cross-contamination and mix-ups.
Facility Layout Design
  • Zoning and Segregation
  • Cleanroom Design
  • Personnel and Material Flow
  • Utility and Support Areas
  • Waste Management
Compliance with Regulatory and cGMP Requirements
  • Review regulatory guidelines (e.g., FDA CFR Part 211, EU GMP Annex 1) for facility design, especially concerning cleanrooms, HVAC systems, and material/personnel flow.
  • Design layouts to prevent contamination, cross-contamination, and mix-ups in product handling.
  • Implement features such as controlled access, airlocks, and pressure differentials to maintain product integrity and environmental conditions.
Equipment Layout and Utility Design
  • Position equipment based on process flow diagrams and consider ergonomic factors for operators.
  • Design utility systems (e.g., HVAC, WFI, steam, Purified water, compressed air) to support equipment requirements and maintain controlled environments.
  • Ensure that utilities are accessible for maintenance without disrupting production.
Environmental Controls and HVAC Design
Objective:
Design an HVAC system that maintains the required environmental conditions throughout the facility.
Activities:
  • AHUs Design
  • Pressure Cascading
  • Filtration Systems
Safety and Ergonomics
  • Design emergency exits, fire safety systems, and safety showers/eyewash stations according to local and international safety standards.
  • Ensure that workstations are ergonomically designed to minimize strain and injury risks.
  • Implement proper lighting, noise control, and ventilation to create a comfortable working environment.
Detailed Design and Documentation
  • Develop architectural, structural, and MEP (mechanical, electrical, plumbing) drawings that detail the facility’s layout, including floor plans, elevations, and sections.
  • Create equipment specifications, utility diagrams, and control system schematics.
  • Prepare a VMP outlining the qualification and validation of facility systems.
Construction and Commissioning
  • Construction Management
  • Commissioning
  • Installation Qualification (IQ)
Qualification and Validation
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Documentation
Final Review and Regulatory Approval
  • Review Documentation for Regulatory Submission
  • Review Inspection Readiness
  • Hand hold for regulatory Approval
Operational Start-Up
  • Training
  • Pilot Runs
  • Continuous Monitoring
Continuous Improvement and Maintenance
  • Routine Maintenance
  • Change Management
  • Periodic Requalification
Services
Contacts
Visit Us

Plot No-138, Ushodaya Junction, Sector 8, MVP Colony, Visakhapatnam, Andhra Pradesh 530017

Any Questions?

+91 87900 46880

Mail Us

maxbizz@mail.com

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