Cold Chain Validation Services

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.

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.

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.

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.

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.