ERA is regularly involved in auditing or issues related to GXP. We are called upon by clients to conduct GLP inspections or provide technical/documentation reviews with respect to GMP issues, either as part of a larger strategic review or as due diligence for selection of third party contractors.
We can offer the following services in this area:
Oversight of GLP studies at key stages:
- Protocol design, review and approval
- During the study: application of test sample such as injection of animals, sampling, sacrifice where applicable
- Troubleshooting of unexpected events
- Review of draft study report before finalisation
Walkthrough of GLP facility on behalf of the client:
- Meeting with laboratory management and interviews with key staff
- Review of key documentation such as training manuals, SOPs and maintenance logs
- Inspection of laboratories, equipment, reagent storage, animal housing and QA/QC units
Review of historical data package including compliance of non-cGLP study data against current requirements.
ERA contributes to the auditing process by documentation review to ensure that product-specific issues are addressed, such as requirements in shared manufacturing facilities. Our expertise has also been called upon during GMP inspections, either to aid in the inspection process or to liase with the inspecting authorities.