ElMaestro
★★★

Denmark,
2019-01-17 17:18

Posting: # 19780
Views: 887
 

 "Annex III: To procedure for (...)": I am so confused :-) [Regulatives / Guidelines]

Hi all,


regarding this link.

1. How would you know it existed if I hadn't pasted the link ? Can you browse your way to it, assuming you know what you are looking for?
2. Is it a document that is "valid" / enforced? How would I know the answer to that?
3. It appears to be an annex. An annex to what and how do I find it?
4. Was "procedure" a verb in 2007? What does the title mean: "ANNEX III: TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA" (sorry about the caps but that's pasted from EMA's homepage).
Do you think they meant something like "To establish principles for conducting GCP inspections(...)"? To establish a procedure?

:confused::confused::confused::confused::confused:

Many thanks. Your assistance is much appreciated.

I could be wrong, but...
Best regards,
ElMaestro
nobody
nothing

2019-01-17 17:41

@ ElMaestro
Posting: # 19781
Views: 784
 

 "Annex III: To procedure for (...)": I am so confused :-)


Kindest regards, nobody
ElMaestro
★★★

Denmark,
2019-01-17 18:25

@ ElMaestro
Posting: # 19782
Views: 769
 

 Bonus questions

Bonus questions:

5. The link above makes references to the PIC/S guidances, specifically the PI011-3 one which makes reference to GAMP.
GAMP, in turn, is pay per view, so...

5a: Does this mean GAMP principles are enforced for inspectors?
If yes:
5b: Does that imply sponsors need to observe principles from GAMP for clinical trial software?
If yes:
5c: When I was a regulator I thought any and all principles that regulators want sponsors or stakeholders to follow is and will be accessible free of charge. I thought this was one of the noble aspects associated with the term transparency which was in almost every other sentence in documents published by agencies. I don't have a reference for it, but I thought was a practice. Can EU regulators enforce principles that are not in the public domain, free of charge, and will they really do so?

6. On a scale from 0 to 100 how grumpy do I sound ? :-D




PS nobody: My colon is fine, thanks for asking. One should never underestimate the importance of proper intestinal health and a good flora. :cool::ok::wink:

I could be wrong, but...
Best regards,
ElMaestro
nobody
nothing

2019-01-17 19:00

@ ElMaestro
Posting: # 19783
Views: 762
 

 Bonus questions

IANAL, maybe it was free at the time of referencing? Dunno...

Grumpy? You are Danish :-D ***runandhide***

Kindest regards, nobody
Ohlbe
★★★

France,
2019-01-18 21:26

@ ElMaestro
Posting: # 19786
Views: 665
 

 Bonus questions

Dear ElMaestro,


» 5a: Does this mean GAMP principles are enforced for inspectors?

My understanding of this document is just that the inspectors announce that they will use the PIC/S guidance as a reference during their inspections.

» If yes:
» 5b: Does that imply sponsors need to observe principles from GAMP for clinical trial software?

That would be a very, very weak legal basis: GCP say that the computerised systems used by sponsors should be validated, but state nowhere that validated means GAMP- or PIC/S compliant. Pretending that this single sentence at the bottom of a one-page document, not endorsed by the CHMP and which nobody can find unless they know it exists (or clicked on every single link on the BEBAC guidance page) is sufficient to make it an official reference text would make any lawyer start licking his lips.

» If yes:
» 5c: When I was a regulator I thought any and all principles that regulators want sponsors or stakeholders to follow is and will be accessible free of charge.

You only worked with medicinal products at that time... Look at the medical devices world: ISO norms everywhere, all coming for a fee, even the GCP norm...

» Can EU regulators enforce principles that are not in the public domain, free of charge, and will they really do so?

No they will not: they won't have access to the text themselves (no budget) :-D
(Except the MHRA, but that's only EU for the next couple of months).

Regards
Ohlbe
Ohlbe
★★★

France,
2019-01-18 21:05

@ ElMaestro
Posting: # 19785
Views: 687
 

 "Annex III: To procedure for (...)": I am so confused :-)

Dear ElMaestro,

» 1. How would you know it existed if I hadn't pasted the link ? Can you browse your way to it, assuming you know what you are looking for?

Yes, thanks to the BEBAC Guidance page :-D
Scroll down to the very bottom of the EMA section, shortly above the HMA bullet point, and you'll get a link to the inspection procedures of the GCP IWG.

» 2. Is it a document that is "valid" / enforced? How would I know the answer to that?

Same as guidelines on the EMA web site : if it's still there, it's still valid.

» 3. It appears to be an annex. An annex to what and how do I find it?

The answer is in the title : it is an annex to the procedure for conducting GCP inspections. There are a total of 7 annexes, on specific topics.

» 4. Was "procedure" a verb in 2007? What does the title mean: "ANNEX III: TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA" (sorry about the caps but that's pasted from EMA's homepage).

I have it in lower case on the page of the GCP IWG, and with the colon in a different position ? Clearer that way.

Regards
Ohlbe
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