Pharmaceutical Equipment, Installation and System Qualification

What is pharmaceutical equipment, installation and system qualification?

Pharmaceutical Equipment, Installation, and System Qualification is a formal, documented process within the pharmaceutical and related life sciences industries that provides evidence that critical assets are fit for their intended purpose and operate correctly. This process is fundamental to ensuring that manufacturing and laboratory environments consistently produce results and products that meet predetermined quality standards.

The core objective of qualification is to verify and document that all key aspects of an installation, from the design and installation phases (IQ), through to operational and performance checks (OQ & PQ), comply with Good Manufacturing Practices (GMP) and other regulatory requirements. By performing these rigorous checks, companies can guarantee that their facilities, utilities, equipment, and systems will not negatively impact product quality or safety.
 

What pharmaceutical equipment, installation and system qualifications do we perform?

Applus+ Laboratories provides a comprehensive qualification service for a wide range of critical systems and equipment to ensure their suitability and regulatory compliance. Our expertise covers:

• Installations and Cleanrooms: Our services include the qualification of cleanrooms and associated controlled environments, HVAC systems, compressed air and medicinal gas systems, and environmental control for classified zones.
• Containment Equipment: We perform qualification for laminar flow cabinets, biological safety cabinets, gas extraction systems, and Restricted Area Barrier Systems (RABS).
• Cleaning and Sterilisation Systems: This includes Clean-in-Place (CIP) and Steam-in-Place (SIP) systems, autoclaves, and depyrogenation ovens and tunnels.
• Thermal Equipment: We qualify a range of thermal equipment, including incubators, ovens, refrigerators, freezers, and climatic and stability chambers.
• Water and Steam Systems: Our expertise covers Purified Water (PW) and Water for Injection (WFI) systems, as well as pure steam generators.
• Production Equipment: We qualify production equipment such as solid dosage mixers and coating pans, liquid and semi-solid manufacturing reactors, and complete filling and packaging lines.
• Computerised Systems: Our services extend to computerised systems, including equipment controlled by PLCs, SCADA systems, and Laboratory Information Management Systems (LIMS).

What are the benefits of pharmaceutical equipment, installation and system qualification?

Engaging in a thorough qualification programme delivers significant operational and business benefits, including:

• Ensuring Regulatory Compliance: It is a mandatory requirement for meeting international standards such as GMP, GDP, and ISO, preventing non-compliance issues during regulatory audits.
• Guaranteeing Product Quality and Safety: By verifying that equipment operates within specified parameters, qualification ensures that product quality, safety, and efficacy are never compromised.
• Minimising Operational Risks: A robust qualification process identifies potential issues before they can lead to equipment failure, batch loss, or production downtime, thereby minimising risk.
• Optimising Processes: The data gathered during qualification provides deep insight into equipment performance, allowing for the optimisation of processes for greater efficiency and reliability.
• Strengthening the Quality System: Qualification documentation forms a cornerstone of a company’s Quality Management System (QMS), demonstrating control over the manufacturing environment.

Why choose Applus+ Laboratories for pharmaceutical equipment, installation and system qualification?

Choosing Applus+ Laboratories means partnering with a global leader in testing, certification, and calibration. Our approach combines deep technical knowledge with extensive experience in highly regulated environments, ensuring we deliver solutions that are both effective and fully compliant.

• Comprehensive Lifecycle Services: We offer qualification services tailored to the entire life cycle of your systems and equipment.
• Adherence to International Standards: Our team works in accordance with the main international standards, including GMP and ISO.
• Customised Protocols: We adapt our protocols to the specific needs of each client and project.
• Commitment to Excellence: We help our clients minimise risks, optimise processes, and strengthen their quality systems.
• Efficient and Compliant Solutions: We provide solutions that are perfectly aligned with today’s demanding regulatory requirements.