MHRA Inspection Preparation and Response
The number of deficiencies being found during MHRA GDP inspections are growing, with an increasing number being related to the quality system. At Laing Pharma, we will work through your quality system alongside yourselves to highlight areas that are likely to cause red flags during inspections and guide you to remediate the issues and to ensure full compliance with MHRA regulations and EU GDP guidelines. As of 2021, the MHRA fees for inspection stand at £1,936.00 before any additional costs such as variation fees. A poor inspection will not only be bad for your reputation, but it can be costly if it results in suspension or even proposed suspension as this could result in additional inspections at the full fee cost. It is therefore crucial to ensure you are inspection ready!
The MHRA will be looking for evidence of your compliance, so often deficiencies come from a licence holder not properly documenting their procedures, so whilst they know they are being compliant, there's no paperwork to prove it and this results in a deficiency. Laing Pharma are experienced in MHRA GDP inspections and we know what the inspectors are looking for, we are able to easily pinpoint when looking through your quality system what is missing and where potential downfalls may lie. Following the inspection, a letter will be sent to the licence holder listing the failures found during the inspection and whether they are critical, major or other (also known as minor). Should the inspection go poorly, you may be referred to the IAG (inspection action group) and sent a Notice of Proposed Suspension (NOPS) where you are then able to respond with any proposed CAPA's and Change Controls that are required in order to try and prevent the suspension. We are able to assist in the NOPS response letter, which is required to be set out in a specific format and sent typically within 30 days. This must adequately address all the findings from the inspection and deal with any potential impact of the issues.
Contact us to discuss your requirements and to see how we can assist you.