Qualification vs validation

Dear All,

What is the difference between Qualification & validation??

a process shall be validated and a equipment shall be qualified

Dear Mr. prasad rao,

What i mean,

What is the relationship between both validation & Qualification ???
Process qualification and process validation are same or not ???
Equipment qualification and process validation are same or not ???
Is qualification is part of validation or validation is part of qualification ???

Please clarify me…

regards
anu

Qualification is the term used to describe the ‘testing’ part of the validation lifecycle. Validation is ensuring that a system which automates a process is fit for purpose, compliant with the appropriate regulations and remains in that state until it is retired.

So qualification is a part of validation, and normally includes verification of the design, installation, operation and performance of a system during the project phase which implements it. It can also include the verification of correct migration of data from an old system into a new system. When the system is in operational use, changes to the system are also qualified.

Process qualification is possibly an error in terminology as we normally say that processes are validated (process validation), and this is different to equipment qualification. Process validation (where a process to produce a product e.g. drug is validated) is different to validating a system to ensure it is capable of supporting that process.

I hope this helps?

Well,

Not going in depth but a littile bit elaborative definition is “Qualification is a challenge study, while validation is not the challenge study. It is regarding re-producibility & consistency”.

In addition to this, the Validation is a Umbrella under which the qualification is come as a part. As the forum already in agreement that System / Hardwares need to be qualified while processes needs to be validated. We can not keep separate both the things. This not about v/s this is about 1 + 1 = 11.

Happy Reading !

Generally, qualification is the activities that are performed on the left side of the V Model and then the validation is what is done on the right side of the V model. I say “generally” very loosely here.

Think of qualification that is something that is commissioned and under control - like a computer server. This is mainly because, by its nature it can change all the time in its configuration, validating it would be difficult. So instead, we say its “qualified”.

Hi Mr. Bread,

Good evening !

Can you please elaborate the “V” Model in a littile bit more depth, for benefit of all readers.

Thanks.

Qualification and Validation are already a bit obsolete terms but still useful.
EU GMP states relation of qualification to equipment and validation to processess.
I have summarised these concept in a following definitions:
Qualification is applied to material objects e.g. equipment, utility systems, hardware etc.
Validation is applied to non-material objects: processes (manufacturing, cleaning, storage), procedures (analytical methods + sampling), software etc.
Some objects are unseparable, e.g. hardware&software, so in this case we use validation as umbrella term (computerised systems validation).
In pharmaceutical manufacture process validation is endpoint of all validation activities because product quality and safety for patients are the main purpose of all GMP measures.

[quote=olspitsky]Qualification and Validation are already a bit obsolete terms but still useful.
EU GMP states relation of qualification to equipment and validation to processess.
I have summarised these concept in a following definitions:
Qualification is applied to material objects e.g. equipment, utility systems, hardware etc.
Validation is applied to non-material objects: processes (manufacturing, cleaning, storage), procedures (analytical methods + sampling), software etc.
Some objects are unseparable, e.g. hardware&software, so in this case we use validation as umbrella term (computerised systems validation).
In pharmaceutical manufacture process validation is endpoint of all validation activities because product quality and safety for patients are the main purpose of all GMP measures.[/quote]

What do you mean when you say a bit obsolete but still useful? Care to elaborate?

[quote=siddhipharma]Hi Mr. Bread,

Good evening !

Can you please elaborate the “V” Model in a littile bit more depth, for benefit of all readers.

Thanks.[/quote]

Hello,

sorry - I don’t get much chance to pop on here as much as I’d like.

There is a good backgound to the V Model in WikiPedia and the link to it is → click

As always, adapt the model to suit your needs, not change your needs to suit the model. You can also find it in the GaMP guide which is available from the ISPE web site (but its quite expensive).

Let me know if you need anything else…

Laters…

P:S. Odracirs post is quite accurate too - he sounds like he knows what he is doing

[quote=Aquarian]Qualification is the term used to describe the ‘testing’ part of the validation lifecycle. Validation is ensuring that a system which automates a process is fit for purpose, compliant with the appropriate regulations and remains in that state until it is retired.

So qualification is a part of validation, and normally includes verification of the design, installation, operation and performance of a system during the project phase which implements it. It can also include the verification of correct migration of data from an old system into a new system. When the system is in operational use, changes to the system are also qualified.

Process qualification is possibly an error in terminology as we normally say that processes are validated (process validation), and this is different to equipment qualification. Process validation (where a process to produce a product e.g. drug is validated) is different to validating a system to ensure it is capable of supporting that process.

I hope this helps?[/quote]

This is an excellent summary, and is my understanding of the definitions as well.

[quote=anusha]Dear All,

What is the difference between Qualification & validation??[/quote]

Qualification is a subset of validation.

Individual qualification steps (URS,DQ,IQ,OQ,PQ) doesnot lead to process validation.

Why because PQ deos not deatails raw material details , yield details , critical parameter justifiction etc where validation has clarification .