Hardcopy GMP Records Archive Regulatory Requirements

M

m_ihab77

Hi,
Does anybody know if there is any guidance available on regulatory requirements (FDA or EU) or general specification of Archives used to store hardcopy GMP Records?
i.e. access control, types of Hazards protection

Thank you in Advance

Regards
Mo
 

Ajit Basrur

Leader
Admin
Hi,
Does anybody know if there is any guidance available on regulatory requirements (FDA or EU) or general specification of Archives used to store hardcopy GMP Records?
i.e. access control, types of Hazards protection

Thank you in Advance

Regards
Mo

Is your question towards document storage requirements or duration of document archival ?
 
M

m_ihab77

Is your question towards document storage requirements or duration of document archival ?

Hi
Thank you for your response, my query is actually about the archive room where the Hardcopy docs are stored
I.e hazard protection, access control etc
Thank u again
 

Ajit Basrur

Leader
Admin
Yes, tsmith has given the right reference. Usually, the document storage area is a ventilated room with limited access control and has collapsible metal cupboards. The area is fire proof.
 
M

m_ihab77

Refer to CFR - Code of Federal Regulations Title 21
(specifically L 21cfr820.180) for the FDA guidance. It is very vague:

"Such records shall be legible and shall be stored to minimize deterioration and to prevent loss."


Thank you tsmith for your help
Cheers
 
T

Talisman

You should also look into the Records Management ISO 15489 - 2001 , ARMA International, and any local guidances. Not every country has these guidances. GMP Records are not different than records in general.
You will also have to look at specific guidances for off site storage as your file room will eventually reach its capacity and you will have to ship records to an off site storage repository.
I would rather no call any records repository "an archives" unless this records are deemed to carrie what is called 'archival value'.
 
C

cspofford1

The FDA requirement is very vague. In an effort to provide clarity to my organization, I did a little more research and the National Fire Protection Agency has published a standard NFPA 232 which states the requirements for document storage which may be helpful. If you log in to their website nfpa.org you can view the standard for free.
Hope this is helpful!
 
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