The MHRA Inspection Process, from application to inspection report

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How do the MHRA carry out inspections?

Those of us who have been lucky enough to attend more than a few know that it can vary slightly, depending on which inspector is leading.

Although the framework remains the same, some inspectors may have particular areas of interest or expertise which can then colour the inspection itself.

What must be remembered is that the MHRA are here to protect public health, and ensure that medicines or devices are fit for purpose, and that they are SAFE.

For those who feel that the inspectorate are difficult or challenging, remember this is their job, and their activity reduces risk to you, your family and your friends.

It is YOUR responsibility to be compliant with GDP, and to ensure that you document everything… and in the eyes of the inspectorate, if you cannot evidence it, you haven’t done it!

So… how does it work?

For those without a WDA(H) aka wholesale dealer authorisation for medicines for human use;

Stage 1 is the application process.

There is a useful document on the MHRA website which breaks this down into a manageable format, in PDF form;

http://www.mhra.gov.uk/home/groups/es-policy/documents/websiteresources/con234529.pdf

Stage 2

Planning;

• After an application has been processed a fee bearing, risk-based inspection will be booked, usually based around the work schedule of the inspectorate.

• Sometimes it is possible to change your inspection date, if it clashes with something important, however we recommend that whichever date is offered should be accepted gracefully.

• The wait time for inspections can be up to 90 working days, and you risk going to the back of the pile.

This is where a site with an existing WL or WDA(H) enters the process:

Stage 3:

Notification:

• The risk based assessment / inspection is planned and advance notice given, in writing.

• The site will be asked to complete a compliance report before the inspection takes place.

• We generally recommend that this is done honestly and immediately, and a copy of the Quality Management System is sent to the inspector in advance of the visit.

Stage 4:

Conduct:

The inspection process has three major stages;

• the opening meeting, with the MHRA Inspector meeting the key staff and explaining what will be required

• the detailed, risk based inspection, carried out by the MHRA Inspector, possibly with a junior/trainee inspector or guest(s)

• the closing meeting, summarising the inspection and giving opportunity for the company to correct any misconceptions

Opening meeting:

• This gives the inspector(s) the opportunity to meet the appropriate key personnel from the business to discuss arrangements for the inspection.

• Confirmation of the business model and information in relation to the premises, security arrangements, areas to be inspected/visited and what documentation will be required is discussed at this point

Risk Based Site Inspection:

• During the inspection the MHRA Inspector will try to determine any failures to comply with Good Distribution Practice and identify the level of conformance.

• The inspector will generally visit the goods in, storage areas (both ambient and refrigerated), goods returns/quarantine areas, and review stock movement and quality management documentation including SOPs, and interview staff.

• Observations, recommendations and deficiencies noted will generally be discussed at the time, and summarised in the closing meeting.

• Occasionally samples may be taken, especially if the inspector feels that they may assist in detection of quality deficiencies, but this is generally in relation to manufacture sites, and less often for wholesalers.

The Closing Meeting:

• The MHRA Inspector(s) gives a verbal summary of the findings and apparent deficiencies, giving the company representatives the opportunity to better explain or clear up any misconceptions.

• Generally the deficiencies are classified as Critical, Major or Other, and the company representatives then have the opportunity to advise what remedial actions will come into play, and on what timeline.

• The attendees of the closing meeting are up to the company, but generally it would be the Responsible Person (or Contract Responsible Person), plus any key personnel, including the senior staff who were present during the inspection.

Post Inspection Letter:

A letter is sent to the company after the inspection, listing any failures to comply with the GDP, as a Critical, Major or Other deficiency.

Dependant on the result of the inspection the inspector may take one of two actions;

• Sends a letter confirming that the company generally complies with GDP

• Recommend to the IAG (Inspection Action Group) that adverse licencing action should be taken against a Wholesale Dealers Authorisation

Referral to the IAG, aka the Inspection Action Group:

• Critical failures to comply are routinely passed to the MHRA’s IAG. The Inspection Action Group are a non-statutory, multi-disciplinary group, and advise the Director of Inspection, Enforcement and Standards Division (aka IE and S) on any recommendation for regulatory or adverse licensing action appropriate to the division.

• The main aim of the IAG is to ensure that public health is protected by ensuring licensed activities in the manufacture and distribution of medicinal products meet regulatory standards.

There is an overview of the Inspection Action Group process available on the MHRA website;

http://www.mhra.gov.uk/home/groups/comms-con/documents/websiteresources/con031119.pdf

Company Response:

• After receipt of the Inspectors report, the company has an allotted time to respond and advise of remedial actions that will be (or have been) taken in relation to resolving failures to comply.

• If the actions are planned, a timescale for the activity to occur should be noted.

• Responses should be made on the basis of placing the deficiency within the wider quality system, rather than the isolated specific matter identified by the inspectorate.

• We recommend that you copy and paste the deviations, and add your response after, summarising in one document, which can be sent electronically.

The inspectors generally request for the response to be structured as follows:
• Restating of the deficiency number and the deficiency as written below it
• Stating the proposed corrective action
• Stating the proposed target date for the completion of the corrective action(s).
• Inclusion of any extra (mitigating) comment the company considers appropriate.
• Provision of the response as an electronic version via e-mail.
Inspection Report:

Once the inspector has an assurance and is personally satisfied that corrective actions have been taken, or are in hand, and that the site is essentially compliant with Good Distribution Practice, an inspection report and close-out letter are finalised and sent.

Want to review this on the MHRA Website? http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodDistributionPractice/Theinspectionprocess/