Ensure Product Integrity with Our Cold Chain Validation Services

Leverage our expertise in cold chain logistics and warehouse validation to safeguard your valuable products throughout their lifecycle. Our services ensure strict adherence to regulatory standards with unmatched precision and reliability.

  • Custom Protocols: Tailored IQ, OQ, and PQ protocols for comprehensive functionality assessment.
  • Cold Chain Mastery: Rigorous temperature and humidity control compliant with  USP <659> standards.
  • Data-Driven Assurance: Real-time data logging and calibrated sensor technology for consistent environmental accuracy.

Partner with Quantus for innovative cold chain logistics validation services, characterized by meticulous attention to detail and a steadfast commitment to quality. With us, gain the confidence of unparalleled precision and dependable excellence.

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Frequestly Asked Questions

What standards do your warehouse validation services meet?

Our warehouse validation services adhere to stringent regulations across the pharmaceutical, biotech, and medical device industries. We ensure compliance with:

  • FDA: cGMP regulations per 21 CFR Parts 210 and 211, and electronic records standards per 21 CFR Part 11.
  • EMA: EU GMP guidelines, particularly Annex 15 concerning qualification and validation.
  • ICH: Quality guidelines including Q7, Q9, and Q10 for active pharmaceutical ingredients, risk management, and quality systems.

These standards, alongside USP <659> for Controlled Room Temperature, and monographs like the USP <1079> for good storage and shipping practices, guide our comprehensive validation to meet and exceed regulatory requirements for storage environments.

How does Quantus' Cold Chain and Warehouse Validation Service process work?

Our validation service is tailored to ensure precision and compliance in your cold chain and warehouse operations. Here's a snapshot of our process:

  • Protocol Customization:

    • Begin with choosing from our set of standardized protocols or opt for a custom solution, designed to align with your specific needs and rigorously reviewed by your QA department for approval.
  • Expert Execution:

    • Our validation engineers, equipped with NIST-calibrated mapping tools, meticulously conduct environmental uniformity studies.
    • A comprehensive study is carried out over 3 to 5 days, or as required by your operations, to ensure thorough environmental control.
  • Seasonal Verification:

    • We perform assessments during different seasons to confirm that your facility's environmental management system consistently performs well, regardless of external weather conditions.
  • Comprehensive Reporting:

    • After data collection, our team provides an in-depth report including:
      • Executive summary for an at-a-glance understanding of outcomes.
      • Detailed protocols outlining the validation process.
      • Visual aids such as images and charts for easy interpretation of data.

The result is a finely tuned service that not only meets regulatory compliance but also delivers the value and assurance needed for optimal cold chain and warehouse management.

Can your services be customized for different warehouse sizes?

Yes, our validation services are scalable and can be tailored to accommodate any warehouse size or specific client needs, from small-scale storage facilities to extensive distribution centers.

What is involved in the mapping study of the warehouse?

The mapping study involves strategically placing calibrated sensors throughout your warehouse to record temperature and humidity over a set period, ensuring the operating range meets specified criteria for product safety and regulatory compliance.

How do you handle deviations or non-conformances during the validation process?

Any deviations from the specified acceptance criteria are thoroughly documented, investigated, and resolved in partnership with our clients to ensure continuous compliance and product integrity.

What clients are saying

  • I am very pleased with the services provided. The technicians are exceptional to work with, and the customer support team is incredibly responsive and accommodating. The pricing offers excellent value for the services provided.

    Century Therapeutics Drew

  • The technicians here do an outstanding job. I truly appreciate the responsiveness of the customer support team and their proactive approach to scheduling.

    Ellume Ken

  • Everything is going great with the services. The technicians are top-notch – professional, honest, and very solid in their work. They provide excellent communication and feedback.

    RegenXBio Blake

  • Working with Quantus to resolve the disorganization of previous 3rd party reports. I have received positive feedback on the work Quantus is doing. We're looking forward to a meeting with the top management and business development teams to gain more feedback and develop additional controls.

    Christiana Care James

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Get in touch with us today and we can help.

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