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Preparation for Inspection

Even the most organised facilities have cause for concern ahead of a regulatory inspection, and the staff resources required during the preparation period can be very disruptive to normal business.

The MHRA carries out statutory GCP inspections that can be systems based, trial-specific or a combination of both. In recent years, there has been an increased emphasis on laboratory facilities that are required to work to GCP standards (GCLP). During inspection, the inspectorate will typically carry out reviews of trial documentation and of sample traceability (receipt, processing/analysis, reporting, and storage). They will also seek evidence to support the integrity of the laboratory result (e.g. QC and QA checks, equipment maintenance and training records, the review and release of results).

Inspections carried out by the HTA in the research sector will assess compliance with the Human Tissue Act 2004, and in the application sector with the Human Tissue (Quality and Safety for Human Application) Regulations 2007. The focus during a site visit inspection by the HTA is on reviewing operational policies and procedures, inspection of premises, scrutiny of practices which involves review of documentation, and in some cases interviews with a range of staff at the establishment. They will also want to be satisfied that the Licence Holder and Designated Individual named on each licence are suitable, and that they undertake their duties and fulfil their responsibilities.

How can we help?

ResLabQ&C can help to prepare you for an upcoming regulatory inspection. We can advise on your strengths and weaknesses, about how to handle any shortcomings, and provide a plan that will give you and the regulatory body confidence that you are in control of your regulatory responsibilities.

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We can help by providing any of the services below:

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  • Conduct a full or themed compliance review

  • Identify gaps and weaknesses and advise on their correction

  • Advise senior management on their responsibilities

  • Review documentation, policies, and procedures

  • Prepare documentation requested by the regulator in advance of the visit

  • Undertake mock inspections, including interviewing and providing feedback to employees

  • Support the response to the inspection report

  • Manage timelines and associated actions post inspection

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Our dedicated support will help to allay anxiety and minimise the inevitable drain on staff resource pre- and post-inspection.

Like what you see? Get in touch to learn more.

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