PHARMACEUTICAL INDUSTRY
PROJECT MANAGEMENT - EQUIPMENT & CLEANROOM INSTALLATION PROJECTS
Pharmaceutical manufacturing operates within a highly regulated environment where product quality, patient safety, and regulatory compliance are paramount. Even minor changes to facilities, utilities, or manufacturing processes can impact product quality and therefore require careful planning, risk assessment, and cross-functional collaboration.
Successful project delivery depends on close coordination between Engineering, Quality Assurance (QA), Quality Control (QC), Manufacturing, Production, Microbiology, MS&T, Validation, Health & Safety, and Regulatory teams. Soluen has extensive experience supporting engineering projects within GMP-regulated facilities, ensuring that technical solutions are delivered efficiently while maintaining compliance and minimising disruption to manufacturing operations.
QUALIFICATION & VALIDATION
Qualification and validation are essential to demonstrating that facilities, equipment, utilities, and processes are fit for their intended purpose and consistently operate in compliance with GMP and regulatory requirements.
Soluen provides practical engineering support throughout the qualification and validation lifecycle, from equipment design and selection to installation, commissioning, and operational verification. Our experience enables us to work closely with engineering, production, and quality teams to ensure new and modified systems are implemented efficiently while maintaining compliance.
Our services include:
- Qualification Plan
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Qualification Report
- Validation Support
- Design Review & Compliance Assessment
- Commissioning & Qualification Support
