Shipper Qualification

  • Custom protocol consulting and development, or seamless execution of your own protocols.
  • Quickly-delivered, quality-reviewed qualification documentation for confidence and compliance.

 

Choose Masy for Accurate Calibration

Ensuring Compliance by Performing your Shipper Qualification

Per cGMP best practices and other industry standards, shipping container systems (“shippers”) must be fully qualified to demonstrate the ability to maintain appropriate storage conditions for temperature-sensitive pharmaceutical products during transport, and can demonstrate that the system can survive transport and handling whilst protecting the physical integrity of the product.
 

 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

Masy BioServices can work with you to create a custom protocol procedure or follow your existing protocol to complete your shipper DQ, OQ, and PQ as required. We provide trained and experienced validation personnel and the required equipment to provide you with a full qualification package. We can work with you to create a custom protocol, or we will follow your Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols in accordance with US Food and Drug Administration, current good manufacturing practices (cGMP) and other cGxP guidelines. We can help you develop:

  • IQ Protocols: Establishes that the shipper is properly and safely installed.
  • OQ Protocols: Verifies that the shipper consistently meets operational specifications such as alarms, controls, and operates as intended.
  • PQ Protocols: Verifies that the shipper consistently meets performance specifications under dynamic conditions.
  • RQ/CQ Protocols: Verifies that the shipper consistently meets operational specifications while the shipper is in use, ensuring a robust compliance posture for your company’s continuous qualification efforts.
 
Wide Range of Calibration Capabilities

Unparalleled Experience in Shipper Qualification

The qualification has three sequential steps: design qualification (DQ), operational qualification (OQ), and performance qualification (PQ). The DQ is not required if the manufacturer can demonstrate that the product has already passed an appropriate conformity assessment, or if the shipper has been independently pre-qualified per end user requirements. Also, if the system manufacturer can supply a satisfactory OQ report that meets the end user’s specifications request, the OQ may not be performed.

The PQ, however, is mandatory in most cases and must be conducted as a field test. A performance qualification protocol must be developed to document the process and define acceptance criteria that are similar to the criterion defined in the DQ and OQ protocols. The PQ requires a minimum of three runs for both the minimum and maximum product load for each of the hottest and coldest months of the year (summer and winter).


Wide Range of Calibration Capabilities

Validator 2000, Premium Thermocouples, and Wireless Dataloggers

Based on your unique needs, we can use the gold-standard Kaye Validator 2000® with premium or ultra-premium thermocouples to perform your shipper qualification, or we can use DataTrace wireless dataloggers. Both options offer accuracy and reliability for your temperature mapping projects.


Fast Calibration Turnaround Time

Post-Qualification Verification of Qualification Test Equipment Confirms Accuracy

All certified validation and calibration equipment used at our customer sites are verified upon return to our NVLAP-accredited metrology laboratory. This completes the physical execution of the qualification activity that took place at your facility. No other validation company provides this level of confidence that their equipment is accurate, stable and repeatable.

Additionally, our own credentialed Quality Department will review all validation reports before delivery to ensure our final product to you meets our exacting standard. We also retain a digital copy of your completed report to assist you with future audit questions, should the need arise.

 

Contact Masy for Calibration

Quick Delivery of the Documentation Package

At the conclusion of your project, we will provide a clear, comprehensive validation report, confirming that your equipment is compliant to your standard operating procedures. Our validation reports contain all of the data necessary for you to have confidence in the operation of your equipment; each one is written to comply with your quality assurance practices, as well as cGMP and FDA requirements. 

Validation reports typically include:

  • Summary Report
  • Executed protocol
  • Real-time, hard copy, and soft copy of the raw data
  • Calibration certificates for all test equipment used, noting NIST traceability
  • Sensor calibration reports
  • Validation personnel detailed résumé
  • Electronic backup files for all studies
 

Contact Masy for Calibration

Fast Turnaround Time Keeps your Operations On-Schedule

We understand that your equipment being out-of-tolerance, or down for validation testing, can negatively impact your production schedules and capacity. We will supply enough personnel and equipment to complete the project within your specified timeframe.

 

Contact Masy for Calibration

Choose Masy BioServices for your Shipping Container Qualification Needs

When you choose Masy for your shipper qualification projects, you can enjoy the confidence that comes with knowing that your critical equipment is qualified to the highest possible standard, ensuring compliance with your SOPs and cGMP regulation – keeping your materials and products safe and effective.


Contact Masy BioServices today for your shipper qualification needs.

 

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