Last year, I wrote about some of the reasons that trigger short notice or unannounced inspections to occur. The previous post centred around our ability to manage resource effectively and to highlight that these kinds of inspections will be occurring on a more frequent basis in the future. This post will concentrate on when these types of inspections occur due to an increase in risk factors such as; a potential patient safety issue, serious breach of GMP or suspected criminal activity (e.g. operating outside of the licensed activities).
We work with other government agencies on many different initiatives in order to protect public health. One such agency is Border Force and we often receive emails or telephone calls from them querying imports to ensure the receiver of the goods has the appropriate licence and in the case of Active Pharmaceutical Ingredients (APIs), that the API is named on the company's registration or the quantities imported were unexpected and therefore needs to be investigated. This type of enquiry can often lead to the Inspectorate performing a number of different activities. It could be contacting the site in question and asking for clarification for what is occurring. It could be (dependant on the nature of the import) that we perform a short notice or an unannounced inspection and we may be accompanied by our enforcement colleagues and anyone else we think is appropriate in line with Regulation 334 of the Human Medicines Regulations 2012 (as amended):
334.— (1) An inspector entering any premises by virtue of regulation 325 or of a warrant under regulation 326 may be accompanied by such persons, and take such equipment, as the inspector thinks appropriate.
We also have access to a number of sources of information which may lead to a short notice unannounced inspection being triggered. During routine inspections we often pick up intelligence concerning other companies and this may result in us taking further action. We also have a dedicated ‘whistle-blower’ email that receives all types and kinds of information pertaining to activities considered to be serious GMP breaches or companies performing activities outside of their legal authorisation.
We have previously received emails from ex-employees of licensed sites where they claim they have witnessed something they do not believe to be correct. In some cases, this is due to a misunderstanding of the GMP requirements and there is no case to answer but equally, we have also been informed of wrongdoings that have subsequently been confirmed during an inspection of the site, ultimately resulting in regulatory action (such as removal or suspension of a licence). If in doubt, we'd rather people contact us so we can assess the concerns as there could be an impact on product quality and patient safety.
Therefore, if you do witness activities that you believe will harm a patient or are outside of a licence holder’s authorisation, then do please get in touch with the specific details you already possess. We have a duty of care not to disclose your identity, with staff specifically trained for this, so you can approach us in confidence. Please do however note that if you provide us with information, after an initial acknowledgement email, we cannot update you with any aspect of your referral due to legislative purposes.
The reasons for performing short notice and unannounced inspections therefore vary greatly as described in parts 1 and 2 of this blog post. Please do not be alarmed if you are a receiver of a short notice or unannounced inspection, the likelihood is it will be the routine inspection being slotted in for efficiency reasons. This also serves as a gentle reminder to always be inspection ready because you never know when the inspector may call.
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Access our guidance on good practice for information on the inspection process and staying compliant.
4 comments
Comment by Fiona Wallace posted on
A good common sense approach and great to hear more about the inner workings and logic of the MHRA and inspections.
I believe this blog serves to foster the understanding of the goals of the MHRA, which ultimately lead to patient safety and data integrity.
A suggestion for a future blog perhaps : what are the most common areas that sites/CROs/sponsors etc are lacking in when it comes to preparation for inspections? E.g. is the TMF quite often incomplete / not up to date, people don't understand their specific job role? etc. I appreciate the inspections are wide ranging e.g. GCP, GMP, routine, triggered etc, but think it would helpful for the wider clinical trials community to understand how to make inspections more efficient and productive for both the inspectorate and those being inspected.
Comment by Mark Birse posted on
Fiona,
Good to hear that you finding the blog useful.
Thank you for the suggestions for future posts. We have a number that we are working on that are focused on the clinical trial community and we will be publishing these over the coming months.
Kind regards,
Mark
Comment by Sheryl Sanderson posted on
Hi,
Is there a way to run a scenario past an inspector/ inspectors, for their opinion? I have been in situations within the department where we have disagreed about how serious an inspector would deem it to be. The divide seems to be those who feel that inspectors only consider the issue in black and white and would come down hard and those who feel that it would be looked at in context and common sense applied. Both opinions are really just guesses, it would be nice to test the theory.
Comment by Sara Berry posted on
Dear Sheryl,
The below are email addresses for each of the inspectorates, where you can obtain further guidance:
GMP: gmpinspectorate@mhra.gov.uk
GDP: GDP.Inspectorate@mhra.gov.uk
GCP: ctdhelpline@mhra.gov.uk
GPVP gpvpinspectors@mhra.gov.uk
GLP GLP@mhra.gov.uk