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Completing a GMP inspection
From your to-do list, click on the GMP inspection that you want to work on.
GMP inspection and system audits both have a page that shows you all of the questions.
You can scroll through all the questions and they can be completed in any order that you like.
Let’s start by going into the first question.
You can see on the left-hand side you’ve got the question itself, and then it gives you the reference for the clause to which this question came from.
Clauses without prefixes are related to your core standard, and these are always shown first. If the question relates to more than one clause each clause will be shown.
If you are on Plan 4 and have assigned additional standards, these would also appear after the core standard clauses. All the additional standard clauses are prefixed.
For example, for M&S the prefix would be MS or MSI for the integrity standard.
On the right-hand side, you’ve got the results of the question.
Here you can say whether it’s conforming or not, or if it’s not applicable.
For GMP inspections, if you click ‘yes’ or ‘not applicable’, you can move on through the questions.
But, if you define something as non-conforming by clicking ‘no’, then you are required to write something in this notes box before you’re allowed to move on to the next question.
Under the notes, there’s an evidence button allowing you to upload any supporting evidence. Clicking the evidence button will open a modal.
From here you can upload files in various formats, for example, images or videos.
You can also give each piece of evidence an additional title to help you identify it.
If you’ve selected ‘no’ then you’ll also get this additional tick box. This will allow you to close out the issue during the inspection.
For example, if you tell somebody on your inspection that there is an issue.
They go off to clean or fix it or whatever it is and they come back during the inspection to say it’s been corrected.
Then you can close that out and note what they’ve done about it and provide evidence to show that it’s been completed.
So essentially, you’re raising the non-conformance, completing and verifying it all at the same time.
You’d then continue to work through all the questions.
You don’t have to complete them all at the same time, you can save your progress and complete it at your own pace.
When a question has been answered, you see a tick next to it on your question list. The colours of the ticks represent how you answered the question.
Once you’ve answered all the questions, you’ll see you get a new button to complete the GMP.
Clicking this button will open a modal.
From here you can either complete the inspection by pressing the ‘Confirm’ button. This will mark the inspection as complete, and at this point, it will no longer be editable. It will be removed from your to-do list and will go to your programme information GMP inspections tab in read-only mode. The accountable manager for that GMP inspection area will receive a notification for all GMP questions for their area that are non-conforming.
Clicking the edit button would allow you to make further changes to your inspection before completing it.
Once you’ve made any changes you’d simply return to this screen in order to make sure you complete the inspection.
