Safeguard the quality of your pharmaceutical processes with a conclusive approach to qualification

Qualification: essential in a regulated sector

Unlike other industries, a project in the pharmaceutical industry doesn’t end with its technical delivery. Systems that impact product quality must be qualified in accordance with a strict process. This qualification starts in an early project phase and, together with validation, forms the final step before commissioning.

All relevant systems are bundled in a Validation Master Plan (VMP), drawn up in consultation with the client’s quality team. Each system is subsequently subjected to a series of verification processes and tests that make up the V cycle. Sweco supports these processes step by step, providing technical expertise and regulatory knowledge.

Our support throughout the V cycle

Sweco offers specialised support during all steps of the qualification:

• Validation Master Plan (VMP): drafted in association with the client’s QA department
• URS compilation: translation of functional and performance requirements
• Design Qualification (DQ): the design is aligned with the URS
• Factory Acceptance Test (FAT): the equipment at the supplier’s premises is inspected
• Site Acceptance Test (SAT): verification after installation on site
• Installation qualification (IQ): static systems verification
• Operational qualification (OQ): dynamic performance test for all systems

For all these steps, we draw up pre-approved test protocols and provide transparent reporting. These protocols serve as the foundation for a conclusive qualification process.

 Validation: prove it works, every single time

In most cases, qualification is followed by another validation phase, also called Performance Qualification (PQ). It involves the entire production process being tested under real-life conditions. Although this step is usually carried out by the client, we provide support for the preparation or execution if required.

 A reliable partner for pharmaceutical projects

Sweco has years of experience in supporting pharmaceutical construction projects and processes. We understand the importance of compliance, traceability and documentation – AND we speak the language of technology and quality. We ensure that your system not only functions optimally in technical terms, but also complies with all the regulations and expectations of audit organisations.

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