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Histology: Making Sure The Study You Outsource Stays GLP Compliant

You want to outsource the histology portion of your preclinical study, so you must ensure the project remains GLP compliant. Good Laboratory Practices (GLPs) guide how “laboratories plan, perform, monitor, document and archive study activities in an effort to enhance the quality and validity of test data.” Preclinical research studies generating data for submission to the Food and Drug Administration (FDA) must adhere to these guidelines no matter where the study is conducted or who performs the work. This means that contract laboratories, like the one you may outsource your study to, are also subject to FDA surveillance audits.

The first step in outsourcing to a contract laboratory is for your Quality Assurance Unit to  schedule an on-site facility audit of the facility. Basically, you want to ensure the contract laboratory has proper Standard Operating Procedures (SOPs) in place for handling your GLP study. Before the visit, it is a good idea to ask the potential laboratory for a copy of their organizational chart and floor plan. Reviewing these two documents will help you to understand the laboratory’s personnel structure and ensure there is the necessary workspace available in their facility to handle your study.

Once you are onsite at the potential contract laboratory, your inspection should begin with a review of all facility SOPs pertaining to the histology portion of your study to ensure that lab processes are conducted the same way every time without variation or undocumented deviation. Pay particular attention to procedures on sample handling.

You’ll also want to review the following records to make certain they are completed, dated, initialed and signed per the SOP and accurately reflect the laboratory’s operations:

  • Most Recent FDA Audit Documentation
  • Standard Operating Procedures (SOPs)
  • Personnel Qualifications and Training Records
  • Instrument Calibration and Maintenance Records
  • Master Schedule
  • Reagent Records
  • Sample Receipt and Processing Records
  • Deviation and Error Correction Reports
  • Quality Control Audit Reports

Once you’ve completed a review of the SOPs and supporting documents, ask your lab partner to guide you through the life of study from receipt, document creation, through processing, and archival or shipment of study materials. Check that they are following their own SOPs by comparing your observations of each process with what is written. Ask questions about any concerns or discrepancies noted. Ask if there are Corrective Actions Preventive Action (CAPA) plans in place to identify, document, analyze and correct problems.

Ask... until you’re satisfied that the histology portion of the study you may outsource remains GLP compliant!

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