News & Events

Store Preclinical Study Materials in Compliance with FDA Good Laboratory Practices (GLPs)

archiving.jpg

Preclinical research studies generating data for submission to the Food and Drug Administration (FDA) must adhere to Good Laboratory Practices (GLPs). These practices embody a set of principles that guide how laboratories plan, perform, monitor, document and archive study activities in an effort to enhance the quality and validity of test data.  Below, you’ll find some practical tips on finding the right archiving facility for the long term storage of your study materials:

Contract with a facility who has been audited by the FDA

Knowing that the facility you intend to place your ambient, refrigerated and/or frozen materials with has been audited by the FDA is important.  “Passing” a surveillance audit by the FDA is no easy task.  If the facility was not given a Form 483 and no objectionable conditions where cited, then the chances are this facility is well managed.

Visit the storage facility to see where and how your materials would be stored

GLP regulations state, “There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens.”  So, it is important that the facility meet or exceed these requirements.

Ensure the facility is safe and secure

  • Building to withstand inclement weather.
  • Each vault is protected by a FM-200 fire suppression system and NOT A SPRINKLER SYSTEM which will damage your study materials if there is a fire.
  • Each area should have controls for temperature, humidity, and ventilation. Paper documents should not be stored under high humidity or in areas used to store specimens containing formaldehyde.
  • Back-up generators are desirable to protect against power outages, especially to refrigerators and freezers where specimens may be stored.
  • Access to the facility should be limited and controlled.
  • There should be a policy in place for how your materials are tracked and retrieved.

Feel free to ask management about any discrepancies you notice or any potential risks that make you feel uneasy. They should be happy to answer your questions and assure you that your study documents are being stored in compliance with Good Laboratory Practices.

HSRL Specializes in Histopathology & Specimen Storage Services

 

Back to Index