MHRA inspection process

by | Apr 27, 2023 | Blog, MHRA

At the recent MHRA GDP Symposium held in February the inspectorate announced a change to the MHRA inspection process.

The change involves moving from site based inspections of WDA holders to licence based inspections.

This constitutes quite a significant change to the MHRA inspection process as it means that license holders who have multiple sites nominated on their licence can expect to have one inspection of the licence which would cover all sites named on that licence, rather than each site being inspected individually.

Whilst this may seem like a blessing there is a note of caution, the caveat from the MHRA is that all other sites named on a licence may be subject to short-notice or unannounced visits – thereby ensuring that all sites must maintain a state of inspection readiness at all times.

Pharmacy Consulting Limited can offer a range of services to help maintain your GDP compliance, including training, GAP Analysis audits, support with your annual self-inspection program and pre-inspection readiness assessments. For more information on how we can help contact us on: 01252 375362 or via our website at www.pharmacyconsulting.co.uk/contact/

Testimonials

I attended one of the first virtual GDP Responsible Person Cogent “Gold Standard” training sessions due to the Covid-19 social distancing requirements. regardless of the circumstances the training was well organised and delivered to the required standard. This is why I recommended my associates to utilise PCL. Thank you Ryan, Sally, Adel and Jackie. Goncalo Sousa –  Quality Head UK at the Janssen Pharmaceutical Companies of Johnson & Johnson 05/05/2020
Cogent Gold Standard GDP Online Training