Hi everyone, this is my first thread to this forum, For an intro, i am in a pharma company here at India with the quality systems still not in place( and we are working towards that). My question is about the good distribution practice.If we have a document which have been issued by a department and its controlled copies have been issued to us. Now in case if we have to submit a copy of the document for regulatory submission, Will it be proper to submit a photocopy of the Controlled copy we have with us ( with an uncontrolled copy stamped on it) or should we have the photocopying done from the master documet lying with the issuer??
Is there any written reference or guidelines showing the right practise ??
Pl. help., Thanks in advance

Cheers, Abhishek

Hi everyone, this is my first thread to this forum, For an intro, i am in a pharma company here at India with the quality systems still not in place( and we are working towards that). My question is about the good distribution practice.If we have a document which have been issued by a department and its controlled copies have been issued to us. Now in case if we have to submit a copy of the document for regulatory submission, Will it be proper to submit a photocopy of the Controlled copy we have with us ( with an uncontrolled copy stamped on it) or should we have the photocopying done from the master documet lying with the issuer??
Is there any written reference or guidelines showing the right practise ??
Pl. help., Thanks in advance

Cheers, Abhishek:bigwave: Welcome to the Cove, Abhishek.
I'm not sure about the regulators you have to deal with, but when I deal with the Federal Aviation Administration, they get CONTROLLED documents, not uncontrolled copies. They require a "push" system:
This means we keep a list of holders of controlled copies and notify them when new revision is issued, we collect the old version or get acknowledgement old version has been destroyed.

Why not ask the regulatory entity what THEY expect?

Welcome to the Cove, Abhishek. :bigwave:

I agree with Wes. It depends on how the authoroty in question will be using the document.

/Claes

Why not ask the regulatory entity what THEY expect?

what the criteria for distribution these procedures to copy holders

i mean how to determin the procedure that this people will get a copy from it ?

and such a procedure like control of document is it required to send a copy to all departments ?

In our end, we have a centralized area in which the controlled documents are placed for personnel to read on.
This was established several years ago, because some departments that has a controlled document do not actuallly read the said documents (in years) and it is a waste of time :frust: for the DRCC Personnel to issue a controlled document on the said department(s) and at the same time producing several
sets of Controlled Documents is a waste of money on the part of the company.
For Uncontrolled Copies, these are issued upon request.
We have it documented in our procedure.
Hope this helps.
Best regards,
Raffy :cool: