GMP & Regulatory Compliance

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GMP & Regulatory Compliance

Practical support to meet WHO, EU GMP, PIC/S and national regulatory requirements.

Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are the backbone of compliant pharmaceutical systems. UDQS supports organisations to design, implement and sustain manufacturing and supply chain systems that are globally aligned and practical for local operating environments.

Gap Assessments

  • Full review of facilities & utilities
  • Equipment & documentation audits
  • Practices vs WHO, EU GMP, PIC/S

System Design

  • Process and workflow optimization
  • Personnel and material flow logistics
  • Contamination prevention (QRM)

Cleanroom & Aseptic

  • Zoning and classification mapping
  • Gowning & behavioural controls
  • Annex 1-aligned strategies

WHO PQ Readiness

  • NRA GMP inspection preparation
  • WHO prequalification reviews
  • CAPA development & follow-up

GMP Training

  • QA, QC, & Engineering workshops
  • Compliance culture for Management
  • Operational team immersion

Facility Planning

  • Design review for compliance
  • Equipment qualification support
  • Maintenance & utility standards

GDP & Supply Chain

  • GDP gap assessments (warehousing & distribution)
  • GDSP audits (storage & transport compliance)
  • Cold chain & temperature monitoring
  • Traceability & distribution risk control

Let’s Build Your Path to Business Solutions.

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.