CRE - Ensure that facilities follow GLP guidelines

Where Safety Pharmacology Comes First

Ensure that facilities follow GLP (Good Lab Practices) guidelines.

How can you assess that the CRO will meet GLP?

You can ask for a summary of their GLP processes, but the best thing you can do is to tour their facility with their QA team and witness their GLP for yourself. You will have to do this if you want to review their SOPs (Standard Operating Procedures) as these cannot be removed from site.
Ask questions and give some what-if scenarios.

How do you keep your GLP records?
How did you manage your last audit? Were there any findings?
What is your general process if you have an electrical failure?
What is the procedure for amendments and deviations?

Tour their archives. Ask to see their records. Ask how access to the room is managed.
Review SOPs that are relevant to the study you are considering. Are they up to date? Include a selection of those covering facilities management, equipment maintenance, assays, data management and staff training records. And don’t forget to review their SOP on SOPs!

Of course all CROs do have GLP procedures in place. However, it is best to check that their standards meet your standards. Then you can rest assured that any regulatory audit request would be returned stamped with “no findings.” Oversights in this area can prove very costly down the road and potentially slow down the entire drug development process.

Dr. Caroline Bell
Founder and CEO
SSPCC, Inc.

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