MHRA inspection – Be Ready!

So what does this mean? MHRA inspection Preparation is important especially if you are worried about non-compliance.

Carry out a self-inspection and compare your operations against the guidance, to ensure that you are compliant (at least at a minimum level) within all areas.
However, you should be doing everything set out in the guidelines that applies to your procedures/processes, personnel and equipment.

During your MHRA inspection, the inspectors will be looking for evidence that you are compliant with EU Guidance on Good Distribution Practice for medicines for human use, 2013/C 343/01 and will “mark” you against it.

Do you think you are you effectively following them?

 It is of paramount importance that you are doing what is written down, and you are not doing anything that is not written down. Hoping for a sufficiently good first impression while not being sure of your QMS is not going to be adequate.

If you find deficiencies near the time of the inspection (it’s always a good idea to check), go through the correct procedures and document each step so that even if it’s not fully completed by the time of the inspection you can show that you are aware of the issue and are working to correct it.

To remain compliant and prevent your licence being suspended and thus protect patient safety, it is crucial that you follow the GDP guidance and have evidence that you have done so. Ensure that any deficiencies are corrected/prevented as early as possible. Regular self-inspections will help you with this.

Make sure that you have an effective Quality Management System (QMS) in place. All of your documents (SOPs) and records need to be clear, complete and up to date.

So what will they look for?

Above all, the inspectors will be looking for evidence of your compliance, so if you haven’t documented it then (to them) it will appear as though you haven’t done it (meaning failures/deficiencies will be found).

You must ensure that all staff members have initial and continuous GDP and QMS training (preferably annually) with records and evidence of this available, and that they are all confident in the tasks/operations they carry out.

The RP must have training that enables them to have a vast knowledge of GDP and be able to evidence competency in all of the areas/tasks they are responsible for.

After the MHRA inspection, a letter will be sent to the company listing whether there are any failures to comply with GDP guidelines listing them as either Critical, Major or Other deficiencies. Whether you passed the inspection or not will depend on how many deficiencies were found and what class they were in. Critical deviations are the highest level and will most likely lead to suspension, as will a number of Majors.

If you do not pass the inspection the inspector may refer you to the IAG (Inspection Action Group) with the recommendation that adverse licencing action should be taken against a Wholesale Dealers Authorisation, which could lead to your licence being suspended or revoked.

You will need to make a response to this letter which details how you are going to correct/prevent the deficiencies that were found.

Training, Support and Backup

If you are anxious about an upcoming inspection and need help with your MHRA inspection preparation, or need help with a response letter, contact us with your details using the contact form below to arrange a consultation, quoting “MHRA INSPECTION”.

If Good Distribution Practice training is required, take a look at our online courses or the GDP Webinar front page via the link buttons below, where you can overview the contents and see when the next Webinar is scheduled.