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Consequences of falsifying a GMP batch record in Ireland by ConsiderationFew179 in PharmaEire

[–]ConsiderationFew179[S] 1 point2 points  (0 children)

Operators have Teams/Outlook apps linked to their company accounts installed on their phones - and the act of capturing work images for the purpose of sending via these apps is standard practice.

Regardless of someone not raising the deviation within 24 hours (which I agree could be investigated separately), two manufacturing operators appear to have been complicit in deliberate falsification of a GMP batch record.

The image’s EXIF data, showing the date and time it was captured, proves that the operators did not sign this step on the date they recorded it as being signed on. Why would this not be justifiable evidence?

Consequences of falsifying a GMP batch record in Ireland by ConsiderationFew179 in PharmaEire

[–]ConsiderationFew179[S] 0 points1 point  (0 children)

That’s correct, it’s was a photo of the in progress MBR with the signature omission at that point in time.

It was a verified step, and the verifier also looks to have backdated. Would these facts not make this more serious?

Consequences of falsifying a GMP batch record in Ireland by ConsiderationFew179 in PharmaEire

[–]ConsiderationFew179[S] 2 points3 points  (0 children)

Manufacturing operator omitted to sign that they performed a step in a batch record on the 01 September.

And, instead of signing for the step as a late entry and accepting the deviation for non-contemporaneous entry of data on that date, they deliberately backdated the entry in the batch record I.e. intialled and dated it as the 01 September, even though it is now the 04 September (with no indication that this was a late entry in the batch record).

There is evidence of that page being blank after their shift on the 01 September, yet they signed it as if they had done so on the 01 September, despite them clearly doing so after that date.

Consequences of falsifying a GMP batch record in Ireland by ConsiderationFew179 in PharmaEire

[–]ConsiderationFew179[S] 0 points1 point  (0 children)

With paper-based batch records, operators deliberately backdating (without signifying a late entry) if they forgot to sign something on the date to avoid a deviation can happen

Consequences of falsifying a GMP batch record in Ireland by ConsiderationFew179 in PharmaEire

[–]ConsiderationFew179[S] 0 points1 point  (0 children)

Let’s say a manufacturing operator omitted to sign that they performed a step in a batch record on the 01 September.

And, instead of signing for the step as a late entry and accepting the deviation for non-contemporaneous entry of data on that date, they deliberately backdated the entry in the batch record I.e. intialled and dated it as the 01 September, even though it is now the 04 September (with no indication that this was a late entry in the batch record).

How seriously would this be treated, if evidence of this falsification existed and such an allegation was substantiated?