IQ, OQ, and PQ

Precision Equipment Qualification for Pharmaceutical Manufacturing

At eyetec, we are more than just validation experts; we come from a production background ourselves. This firsthand experience in pharmaceutical manufacturing provides us with unique insights into the daily challenges faced by production teams. Our deep understanding of production processes and strict adherence to GMP guidelines inform our approach to equipment validation, enhancing our ability to develop solutions that meet regulatory standards. 

Our core services include: 

  • Installation Qualification (IQ): We verify that installations align with manufacturer specifications and all regulatory expectations, ensuring a solid foundation for successful operation. 

  • Operational Qualification (OQ): Our testing procedures confirm that equipment operates perfectly under all specified conditions, adhering to GMP requirements and guaranteeing operational excellence. 

  • Performance Qualification (PQ): We validate that your equipment performs reliably under real production conditions, consistently producing quality outcomes in line with GMP standards. 

  • Process Validation (PV): Beyond individual equipment, we ensure the entire manufacturing process is capable of producing outputs that meet quality parameters consistently. 

Why choose eyetec? 

  • Profound equipment knowledge: Our deep understanding of complex pharmaceutical equipment, particularly noted for our specialization in Steelco systems, sets us apart.  

  • In-house calibration: We maintain complete control over calibration processes, ensuring precision and compliance without the need to outsource. 

  • Regulatory expertise & compliance: Our profound understanding of compliance, particularly with guidelines such as Annex 15 and best practices from ISPE, ensures that every piece of equipment is ready for any audits and fully compliant with international standards. 

Your challenges 

We understand the pressures of tight timelines, budget constraints, and the need for first-time-right qualifications. That is why we deliver solutions that address these challenges and improve both your operational efficiency and product quality. 

Schedule a consultation to discuss how we can meet your needs. CONTACT US

how can we help you?

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