Equipment Qualification (IQ|OQ and SAT)
Effortlessly Meet Your Quality Requirements
Equipment qualification is an essential factor for ensuring pharmaceutical drug safety. Regulated environments usually require equipment to undergo qualification. Our specially trained service technicians perform recommended qualifications that meet regulatory requirements. Our risk-based approach enables us to leverage many years of industry experience. We execute approximately 1,000 laboratory specific qualifications each year. Once the qualification procedure is complete, specific protocols are provided to prepare you for your next process validation.
Your Benefits At A Glance
- Confidence in your facility's quality audit performance
- Full compliance with regulatory requirements (GMP)
- Focus on quality-relevant and critical parts
- Peace of mind, comprehensive documentation, and certificates to easily integrate into quality management systems
- Expertise straight from the equipment manufacturer and specially trained service technicians
- Delivery inspection, complete installation and testing of your instrument
- Monitoring of the environmental conditions at the installation site
- Functional tests according to instrument specifications
- All findings documented in GMP compliant qualification template
FAT|SAT for Bioprocess Equipment and Systems
Four options are available for the qualification of bioprocess equipment and systems. Our specialists are available to support your process validation on request.
- Level 1: Material certificates are provided.
- Level 2: Sartorius test documentation templates (IQ|OQ documents) are provided to enable you to perform the system qualification.
- Level 3: Test documentation for your individual system is provided, and the documented execution of the factory acceptance test is performed at our manufacturing facility.
- Level 4: Includes Levels 1-3 above, and our service technicians perform site acceptance tests at your facility.
Stephan Theisen, Service Director Central Europe
In GMP environments, there is simply no room for error. With our risk-based qualification approach, we ensure that all critical control points are reviewed ahead of your audit.
Qualifications serve as proof of suitability for your equipment. Device qualification involves assessing the full scope of delivery and the meeting of equipment requirements and specifications. The entire process is carefully documented. After the device qualification has been performed, the next step, in many cases, is process validation.
A validation furnishes proof that the entire process leads to the expected results and meets predefined specifications and quality characteristics. A process validation, thus, always includes a system and equipment qualification. In the bioprocessing industry, and often in the laboratory environment, both qualification and validation must be carried out in accordance with the Good Manufacturing Practice (GMP) guidelines before beginning production or research.
The qualification and validation form the basis for drug safety and are a prerequisite for all work in a GMP regulated environment.
In August 2012, the US Food and Drug Administration (FDA) introduced the risk-based approach. The aim of the approach is to focus on critical areas during pharmaceutical quality control. All quality assurance measures should, therefore, be justified from the risk analysis.
It makes sense to follow this approach in the qualification of laboratory equipment. During a risk-based qualification, not every function is checked, but rather only those that are risky and can affect quality. Inspection is, therefore, faster and, above all, more efficient.