Malaria Production Revamping

Objective:
​Production Capacity Enhancement and Ramp-up (Malaria)

Sector:
Pharmaceutical industry

Duration:
​12 mois

Team:
1 Project Manager
1 Coordinator
5 Engineer

Solution:
​Full qualification of four critical systems, including risk analysis, DQ, IQ/OQ, and multi-stakeholder coordination.

Results:
Smooth startup, improved compliance, increased reliability, and reduced non-conformities.

Context & Issues

As part of a production reinforcement initiative, the client launched a strategic project involving four key systems: two directly linked to malaria production, and two focused on waste management and decontamination. 

The scope covered: 

  • LPW Equipment Reinforcement
    Installation of an additional purified water sub-loop to meet growing facility-wide demand.

  • Steridrain System
    Upsizing of the system for efficient waste treatment and liquid drainage. 

  • Installation of a Decontamination Station
    A former decommissionned unit was reinstalled and improved to enhance contamination control and safety in waste handling

  • Replacement of Glucose Storage Tanks
    Two end-of-life glucose tanks were replaced with larger-capacity units to improve supply reliability and process efficiency. 



Deployed Solutions

RealDev intervened in the post-design phase, supporting the client throughout the Commissioning & Qualification (C&Q) process and beyond the IQ/OQ stage. 

Our key responsibilities included: 

  • Design Qualification (DQ) and Gap Analysis for three critical systems (LPW, decontamination station, steridrain), ensuring alignment between design documentation and user requirements. 
  • Risk Assessments tailored to each system, essential to Quality by Design, enabling a proactive approach to compliance and safety, and to everyday control of process-critical parameters and actions.  
  • Thorough review of SAT reports in order to anticipate design issues and documentation issues, before starting qualification
  • IQ/OQ Protocol Development and Execution for all four systems, including the newly installed glucose tanks. 


Key Challenges : 

Ensuring full traceability and alignment between functional needs and technical documentation to prevent qualification gaps. 

Coordinating activities across multiple suppliers and subcontractors while maintaining project timelines and data integrity. 

Managing simultaneous qualification tasks across diverse systems with distinct compliance constraints. 

Leveraging audit trail data during testing to detect and resolve inconsistencies early in the process. 


 

RealDev’s Added Value 

A client-focused approach that integrates operational needs into every qualification phase. 

Strong expertise in design documentation analysis and risk-based qualification strategy to ensure project robustness. 

Effective multi-stakeholder coordination to streamline activities and avoid bottlenecks. 

Proactive use of auditing tools and testing insights to anticipate and mitigate potential risks. 

 

 Results

Increased Production Reliability:

Reinforced infrastructure supports higher throughput with reduced downtime. 

Reduced Risk of Non-Conformities:

Early detection of design gaps helps prevent costly rework and compliance issues. 

Seamless Start-up and Operational Readiness:

Structured qualification process ensures a smooth handover to operations. 

Improved Compliance and Safety:

Enhanced systems for decontamination and waste ensure alignment with GMP and regulatory expectations. 

Looking to optimize your production processes?   

Whether you need to migrate existing systems, integrate new equipment, or ensure full compliance and validation, RealDev is your trusted partner in industrial automation and life sciences. Contact us today to discuss how we can support your project! 

Contact Us 

Our blogs
Scale up production capacity (vaccine)