Calibration Laboratory Location - GMP says in a secure bonded area

[Corsair]

The GMP said that a Calibration Laboratory need to be in a secure bonded area for the purpose of the sensitivity accuracy and the functionality of the Quality Assurance Instruments;not to mention Certification files.
It is O.K if you share the Lab- with some other people.
Who be responsable if a tool is tamper or a cert- is miising?

Thanks in advance.

[Stijloor]

Originally Posted by Corsair

The GMP said that a Calibration Laboratory need to be in a secure bonded area for the purpose of the sensitivity accuracy and the functionality of the Quality Assurance Instruments;not to mention Certification files.
It is O.K if you share the Lab- with some other people.
Who be responsible if a tool is tamper or a cert- is missing?

Thanks in advance.

Can someone help?

Thanks.

Stijloor.

[harry]

These are general guidelines for location of lab:

Location is important because of:

• Possible effect on the environmental conditions within the lab
• Be away from sources of mechanical vibration and shock and sources of electrical and electromagnetic interference
• Acoustic noise level should not exceed that of a quiet office
• Ground floor or basement may be more advantageous
• Area should be separate and identifiable and shared only with other compatible activities.

[Ajit Basrur]

Originally Posted by Corsair

The GMP said that a Calibration Laboratory need to be in a secure bonded area for the purpose of the sensitivity accuracy and the functionality of the Quality Assurance Instruments;not to mention Certification files.
It is O.K if you share the Lab- with some other people.
Who be responsable if a tool is tamper or a cert- is miising?

Thanks in advance.

Can you pl specify which GMP regulation says this - not come across this point ?

[Corsair]

I mean that a Cal- Lab- need to be in a secure location and not to be shared with other people that has nothing to do with the Lab-.
In my experience in the aerospace industry I always see this kind of practice.
Common sense,and good GMP.
Is this correct?

[zamclachia]

Originally Posted by Corsair

I mean that a Cal- Lab- need to be in a secure location and not to be shared with other people that has nothing to do with the Lab-.
In my experience in the aerospace industry I always see this kind of practice.
Common sense,and good GMP.
Is this correct?

I would agree . Access to a lab needs to be restricted to authorised people only. "Outsiders" may see certain practices or results without the ability to interpreted what they have seen. Confidentiality between customer and testing facility must be maintained at all times..