Can we show Photocopied Uncontrolled Copies of Documents to an FDA Auditor?

[v9991]

My question is ...whether these R&D documentation sent to manufacturing/audit purpose, be made available as controlled copy? [or, in what circumstances an uncontrolled copies are acceptable.]

Help me if I have missed the point...

 

[Randy]

Instead of playing "He said-She said - I think-We think" why don't you just ask them?

Just seems to me that asking the organization would make sense, but that's me.

 

[harry]

.............................. Product is developed at R&D site and FDA audit manufacturing site and asks for some of the development documents/data from R&D site. .................................

The manufacturing site should have a controlled copy. Otherwise, how do you ensure that the information is current or up to date?

If the auditor asked for a copy as evidence, you can photocopy one for him from your controlled copy. The information in this photocopied document is 'current' the moment it was photocopied. Since you are in no position to follow up or update it subsequently - it shouldn't be controlled.

 

[jscholen]

Since the investigator is at another site, you can tell them if they desire to see the originals, they are welcome to go to the R&D site. If they don't want to travel then tell them they will have a copy provided.

Whether the copy is controlled or uncontrolled, I'll tell you from my experience with an FDA Pre Authorization Inspection....we showed the originals to the investigator, only after we copied what they were viewing, and then if they requested a copy for their records, we made a copy of the original and stamped it "copy".

Once you copy something, it is uncontrolled because it is no longer within the confines of its controlled environment depository. What you may want to state is the the copy is a "Certified Copy"...but it is still uncontrolled.

You will need a "Certified Copy" procedure, in my opinion.

 

[Al Rosen]

My question is ...whether these R&D documentation sent to manufacturing/audit purpose, be made available as controlled copy? [or, in what circumstances an uncontrolled copies are acceptable.]

Help me if I have missed the point...

See my post regarding FDA Inspections.

 

[pthareja]

Re: Photocopied (but original) Uncontrolled Humour

The manufacturing site should have a controlled copy. Otherwise, how do you ensure that the information is current or up to date?

If the auditor asked for a copy as evidence, you can photocopy one for him from your controlled copy. The information in this photocopied document is 'current' the moment it was photocopied. Since you are in no position to follow up or update it subsequently - it shouldn't be controlled.

it enters into a vicious circle of chicken and the egg story.

Photocopy (uncontrolled product) --> control it (process) ---> (authorised product)-----> empower it-----> (becomes potent)

There was a photocopy of an egg.
The chicken said, it was I, before hatching, in my last leg.
The egg said, though I was never ever hatched,
An uncontrolled stay order was the only catch!
But another photocopy produced the results, when chicken begged?

Priyavrat Thareja