The Human Medicines Regulations 2012 as amended; regulation 325 ‘Rights of Entry’ states that an inspector may at any reasonable time enter premises. This allows for the MHRA to perform inspections both at short notice (may be a few days) or unannounced (no notice given). The use of these inspection types allows us to investigate issues that pose a significant risk to public health without obstruction and to work efficiently. We spend a lot of time planning and scheduling inspections but unfortunately there are times when things don’t go to plan and we can find ourselves with the following scenarios;
- There are times when we have no choice for logistical or health & safety reasons but to cancel or postpone a planned inspection at very short notice (for example because an inspector can no longer travel and there is no other available staff to back fill).
- A planned inspection finishes early or is postponed at the last minute (for example if a site is found not to ready to be inspected or an incident at the site means we can no longer inspect).
- Risk information dictates a change to the prioritisation of an inspection.
- A last-minute change to meeting requirements means some inspectors are then free to inspect.
Where a last-minute cancellation occurs, we will look to allocate a replacement site to any inspectors still available to perform an inspection. This will be the next site due for inspection from the routine schedule or an inspection that has been prioritised within the inspectors field of accreditation. Due to the time constraints of this scenario this replacement inspection will be conducted either unannounced or at short-notice. These dates, as part of the short notice programme, are non-negotiable.
A further scenario that would dictate a site becoming part of the short notice programme or having an unannounced inspection would be where the site was unable to agree to the dates that the assigned inspector has available (note this is different to refusing an inspection which is dealt with differently). Currently GMP Inspectors are allocated sites for inspection in a particular quarter during the preceding quarter and it is their responsibility to schedule these into their diary. Routinely for announced inspections a site should get at a least one months’ notice of the planned inspection date. If the dates proposed cause an issue, then the site should raise this with the inspector. Requesting a change of date for genuine reasons will have no bearing on the inspection outcome. However, MHRA has a legal obligation to conduct inspections to determine that the appropriate regulations are being complied with and whilst inspectors will try and accommodate changes to inspection dates they too have other commitments, such as overseas inspection tours, presentations, meetings and annual leave. Therefore, in some cases the inspection may have to go ahead as originally scheduled. The only alternative in this case would be for the site to be returned to the routine schedule list and be picked up by the next available inspector as part of this short-notice programme.
A few things to note with short notice and unannounced inspections performed by this mechanism are:
- You will need to have available during the inspection the details that would have been completed as part of the pre-inspection compliance report, the inspector will obtain this information from you whilst on site.
- You will be charged for the inspection at the normal daily rate per inspector.
- If you choose to refuse the inspector entry to the site, you will be in breach of the obligations you have as a licence holder. This will result in an instant referral to the Inspection Action Group with a recommendation to suspend or not grant the licence as appropriate. Please also be cognisant of Regulation 326 of the Human Medicines Regulations (as amended).
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2 comments
Comment by J Turner posted on
You give four scenarios when you may need to do a short-notice or unannounced inspection and for three of these you give tedious examples of administrative reasons - illness, meetings, etc. You say nothing about the most interesting scenario, 3, caused by "risk information". What sort of risk? Did you have a 'tip-off' or a 'whistle-blower? Has there been a catastrophic batch recall - mis-labelling, non-sterility, rogue tablets, illegal supply? More information here on their frequency, examples of causes and on outcomes (suspension or restriction of Licence, criminal charge?) would be far more valuable and interesting to most readers including me.
Comment by Mark Birse posted on
John - thank you for your comments.
The more interesting scenarios that you mention are also clearly very interesting to us to. They feature as one of the key parts of our risk based inspection programme and drive the majority of our short notice and unannounced inspections.
This post was aiming to raise awareness of the wider reasons why we may be undertake this type of inspection.
This is part 1 of a series of new posts and we will be bringing details on these more 'interesting scenarios' later this year.
Kind regards,
Mark