Auditing

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:

GLP

Oversight of GLP studies at key stages:

Walkthrough of GLP facility on behalf of the client:

Review of historical data package including compliance of non-cGLP study data against current requirements.

GMP

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.