Warehouse Mapping

  • Meeting USP 1079 and cGMPs in the biotech/pharmaceutical industries.
  • 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 Warehouse Mapping Qualification

A shift in focus to quality-by-design rather than quality-by-test, along with an increased focus on patient safety and product quality, has led to increased focus on controlling and monitoring storage conditions. Warehouse and storage area mapping is a key element of meeting USP 1079 and cGMPs in the biotech/pharmaceutical industries, especially when concerning environmentally sensitive products or process components.

Temperature and humidity mapping is performed per customer or Masy BioServices protocol, and the mean kinetic temperature (MKT) is calculated in addition to statistical calculations for each parameter (per the protocol). MKT calculations shows the effect of above or below average temperature readings on stored product, as single high or low readings have a greater effect on the MKT than the statistical average.

 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

Masy employs trained validation engineers and specialists, and has available a fleet of wireless data loggers and related equipment required for all warehouse and storage area mapping. We will execute the warehouse qualification protocol using sensors with a NIST-traceable calibration for both temperature and humidity. Pre-study calibrations and post-study calibration verifications can be performed on the test instruments at Masy BioServices in our primary standards lab. 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 warehouse is properly and safely installed.
  • OQ Protocols: Verifies that the warehouse consistently meets operational specifications such as alarms, controls, and operates as intended.
  • PQ Protocols: Verifies that the warehouse consistently meets performance specifications under dynamic conditions.
  • RQ/CQ Protocols: Verifies that the warehouse consistently meets operational specifications while the warehouse is in use, ensuring a robust compliance posture for your company’s continuous qualification efforts.
 
Wide Range of Calibration Capabilities

Validator 2000, Premium Thermocouples, and Wireless Dataloggers

Based on your unique needs, we can use the gold-standard wireless Kaye RF ValProbes to perform your warehouse 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 Warehouse Mapping Qualification Needs

When you choose Masy for your warehouse 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 warehouse mapping qualification needs.

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