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Hardcopy GMP Records Archive Regulatory Requirements


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european union, fda (food and drug administration), gmp (good manufacturing practices), regulations and regulatory requirements, record retention requirements, paper documents and records, records (evidence) and records control
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  Post Number #1  
Old 15th July 2010, 07:41 AM
m_ihab77

 
 
Total Posts: 4
Question Hardcopy GMP Records Archive Regulatory Requirements

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

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  Post Number #2  
Old 16th July 2010, 06:45 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,911
Re: Hardcopy GMP Records Archive Regulatory Requirements

Quote:
In Reply to Parent Post by m_ihab77 View Post

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 ?
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  Post Number #3  
Old 16th July 2010, 11:08 AM
m_ihab77

 
 
Total Posts: 4
Re: Hardcopy GMP Records Archive Regulatory Requirements

Quote:
In Reply to Parent Post by Ajit Basrur View Post

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
  Post Number #4  
Old 16th July 2010, 11:36 AM
tsmith7858's Avatar
tsmith7858

 
 
Total Posts: 129
Re: Hardcopy GMP Records Archive Regulatory Requirements

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."

http://www.accessdata.fda.gov/script...cfm?fr=820.180
  Post Number #5  
Old 16th July 2010, 11:45 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,911
Re: Hardcopy GMP Records Archive Regulatory Requirements

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.
  Post Number #6  
Old 20th July 2010, 04:32 AM
m_ihab77

 
 
Total Posts: 4
Re: Hardcopy GMP Records Archive Regulatory Requirements

Quote:
In Reply to Parent Post by tsmith7858 View Post

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
  Post Number #7  
Old 10th August 2010, 11:09 AM
Talisman

 
 
Total Posts: 7
Re: Hardcopy GMP Records Archive Regulatory Requirements

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'.
  Post Number #8  
Old 11th May 2011, 04:11 PM
cspofford1

 
 
Total Posts: 6
Re: Hardcopy GMP Records Archive Regulatory Requirements

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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