Issuance of Laboratory Raw data

GOOD MANUFACTURING PRACTICE (cGMP) WHITE PAPERS
1

Dear all,
Is is necessary to issue laboratory raw data for routine analysis?
we are using practice of issuace by QA,but in one of our audit, auditor ask us "where it was mention to issue laboratory raw data?"
Pl. help in finding this solution.
Thanks n Regards,
Punit
:slight_smile:

2

Dear Punit,

I suggest you required SOP on issuance of Raw data ( Sheet for Raw data recording in QC) by QA.

Formally you requried regsiter also for issuance and retriaval of Raw data.

Either prepare the seperate SOP or you can inculde in GDP SOP with Attachment of (Register for issuance and retrival of racord).

If any query please fill free to contact me.

Regards,
Pankaj Sojitra.
Novartis Pharma.
M: 9979842207.

[quote=punit.vyas]Dear all,
Is is necessary to issue laboratory raw data for routine analysis?
we are using practice of issuace by QA,but in one of our audit, auditor ask us "where it was mention to issue laboratory raw data?"
Pl. help in finding this solution.
Thanks n Regards,
Punit
:)[/quote]

3

Dear Pankaj,

Thanks for your prompt reply.

What you had described is correct and same way we are following in our company.

My problem is at the time of discussion, person was asking in which guideline it was written to issue laboratory records.