Chosing a procedure title - "Validation of equipment" or "Qualification of equipment"

Mandy

Involved In Discussions
#1
Should I title the procedure that deals with IQ, OQ, PQ "Validation of equipment" or "Qualification of equipment"?

Thanks,
Mandy
 
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somashekar

Staff member
Super Moderator
#2
Re: "Validation of equipment" or "Qualification of equipment"

Hi Mandy ...
The world calls it as Validation of process.
This needs an approval of equipment.
.
..
So Validation of xxx process
approval of equipment = IQ
 

Mandy

Involved In Discussions
#3
Re: "Validation of equipment" or "Qualification of equipment"

Just to clarify: you are saying a process undergoes validation, but equipment undergoes approval or qualification?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
Re: "Validation of equipment" or "Qualification of equipment"

Its all validation

despite the use of the word 'qualification' in IQ, OQ, PQ...it's all validation
 

Ajit Basrur

Staff member
Admin
#5
Re: "Validation of equipment" or "Qualification of equipment"

Just to clarify: you are saying a process undergoes validation, but equipment undergoes approval or qualification?
Qualification is a subset of validation.

As per the EU GMP guidelines, Qualification is applied to material objects e.g. equipment, utility systems, hardware etc. while Validation is applied to non-material objects like processes (manufacturing, cleaning etc.), procedures (analytical methods + sampling), software etc.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

ISO 13485 also requires validation of the medical device itself.
 
#8
Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

In agreement with the statements of those above, and fyi the title of our procedure when working for an ISO 13485-certified contract manufacturer was "Qualification of Equipment, and Validation of Processes and Software"
 
#9
Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

Should I title the procedure that deals with IQ, OQ, PQ "Validation of equipment" or "Qualification of equipment"?

Thanks,
Mandy
You are qualifying each step of the process (IQ, OQ, PQ) to enable you to validate it.

Your process validation documentation will show that you can operate a process within established parameters and can effectively reproduce results to specifications and quality requirements.

You can call it whatever you like, but for clarity and global marketability, the title 'Validation of XXX' is the most viable in every language
 
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