Pharmaceutical & Vaccine Facility Support

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Engineering & GMP Integration

Pharmaceutical & Vaccine
Facility Support

Bridging engineering design and GMP requirements for world-class manufacturing.

UDQS works at the critical interface of engineering and GMP. We ensure that new and renovated facilities meet stringent regulatory standards, operational efficiencies, and future expansion needs.

Facility URS

  • Cleanroom architectural specs
  • Production area requirements
  • Operational flow integration
  • Expansion-ready layouts

Utility Systems

  • PW / RO / EDI water systems
  • Clean steam & compressed air
  • ETP and Bio-kill systems
  • Instrumentation specifications

HVAC Design

  • Aseptic pressure cascades
  • Air change rate performance
  • Temperature/Humidity control
  • HEPA filtration strategies

GMP Zoning

  • Personnel & Material flow review
  • Segregation of clean/dirty zones
  • Architectural & MEP drawing review
  • Contamination control strategy

Commissioning

  • FAT/SAT participation
  • Site readiness checklists
  • System handover support
  • Commissioning Master Planning

High Containment

  • Biological safety zones (BSL)
  • Vaporized H2O2 sterilization
  • Closed-system processing
  • Cross-contamination risk audits

Sterile & Vaccine Focus

Vaccine manufacturing requires a unique balance of high containment and aseptic precision. UDQS provides specialized support for Fill-Finish facilities and Biological safety zones, ensuring Annex 1 compliance from the first brick.

  • Vaccine fill–finish workflow optimization
  • Aseptic processing area qualification
  • Gowning and de-gowning protocol design

Engineering excellence tested against global quality standards.

Let’s Build Your Path to Regulatory Excellence.

Delivering Global Standards Across Africa

With deep roots in the region, UDQS provides technical intellect tailored to the African regulatory landscape. We transform manufacturing facilities into world-class, export-ready assets.

Audit-Proven Methodologies
Risk-Based Technical Delivery
On-Site Operational Support
Localized Regulatory Intelligence

Our consultants bridge the gap between rigorous international requirements and local operating conditions, ensuring your path to compliance is both sustainable and scientifically sound.

Compliance Frameworks
WHO TRS EU GMP PIC/S ISO 9001 ISO/IEC 17025 ICH Q8–Q12 ISO 14644 ALCOA+ GAMP 5

Ready to Elevate Your Quality Standards?

Our technical experts are standing by to help you navigate the complexities of facility readiness, laboratory qualification, and regulatory submission.