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

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

Thanks,
Mandy

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

Re: "Validation of equipment" or "Qualification of equipment"

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

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

Re: "Validation of equipment" or "Qualification of equipment"

Gazielmd said:

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

Click to expand...

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.

Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

ISO 13485 also requires validation of the medical device itself.

Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

Yes Bev.

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"

Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

Gazielmd said:

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

Thanks,
Mandy

Click to expand...

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