Raw Materials / Product Storage

Raw Materials (RM) and final product storage within the Waisman facility consists of separate “Quarantined” and “Released” security card accessed rooms that contain storage space for room temperature, refrigerated and frozen materials (-20C/-80C). As described below, our raw materials and final product holding systems are designed to make certain that both RMs used in clinical production runs and product released for clinical trials have the proper regulatory storage and documentation. We also recognize that the security of all storage areas and our client’s valuable resources is paramount. One of our top priorities is making certain you have confidence in the integrity and safety of your product within our facility.

Raw Materials Holding

  • Continuous locked storage during RM transit from building entry point into facility with documentation detailing chain of custody
  • Locked storage of incoming materials designated “Quarantined” prior to release for use in GMP production
  • QA review of documentation (Certificate of Analysis) verifying products meet all specifications/testing
  • Separate locked storage of materials designated “Approved” after QA release
  • Documentation system in place for inventory control and lot specific tracking
  • Secure archives of all RM related documentation
     

Final Product Holding

  • Locked storage of "Quarantined" final product prior to QCS release testing
  • Separate locked storage of final product designated "Approved" after QA release


Storage Security System

  • Key access refrigerators and freezers for RM storage
  • Locked storage of client final product ensuring its integrity and safety
  • Refrigerators/freezers annually calibrated and validated
  • Continuous temperature mapping by Rees Equipment Monitoring System to track excursions
  • Auxiliary backup system in place for all vital pieces of equipment