Process Validation - Production Line Transferring to a Different Facility

[Keep Smiling]

Our west coast plant is coating a blade for medical end use. The line is transferring to the midwest, and the customer is asking for our plan to capture process validation. I am in aerospace, so the lingo is all new to me.

If the process is the same, and equipment is similar (but not the same pieces) which qualifications are applicable: IQ - Installation Qualification, OQ - Operation Qualification, & PQ - Process Qualification? Any examples of document formats?

All help is appreciated

[Ajit Basrur]

Originally Posted by Keep Smiling

Our west coast plant is coating a blade for medical end use. The line is transferring to the midwest, and the customer is asking for our plan to capture process validation. I am in aerospace, so the lingo is all new to me.

If the process is the same, and equipment is similar (but not the same pieces) which qualifications are applicable: IQ - Installation Qualification, OQ - Operation Qualification, & PQ - Process Qualification? Any examples of document formats?

All help is appreciated

Welcome to the Cove and yes, as suggested by you, I am smiling too

Let me give you the basic definitions of DQ, IQ, OQ and PQ and then that will be more clearer. The entire requirement becomes necessary because of one point that you have pointed out - similar but not same

The qualification and validation process is done to establish and provide
documentary evidence that:

The premises, the supporting utilities, the equipment and the processes have been designed in accordance with the requirements of GMP. This normally
constitutes Design Qualification or DQ.

The premises, supporting utilities and the equipment have been built and installed in compliance with their design specifications. This constitutes Installation Qualification or IQ.

The premises, supporting utilities and the equipment operate in accordance with their design specifications. This constitutes Operational Qualification or
OQ.

A specific process will consistently produce a product meeting its predetermined specifications and quality attributes. This constitutes Process Validation or PV. The term Performance Qualification or PQ may be used
also.

The next question is when to qualify and validate -

Any aspect of, including significant changes to, the premises, the facilities, the equipment or the processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.

In your case, since the entire line is being transferred, you would have to start right from the Installation Qualification to confirm if the installation is being done correctly in the first place.

Hope this clarifies.

[Bev D]

quite simply: you should perfrom IQ, OQ and PQ. Of course you dont'tthink anything will be different or you wouldn't be asking. But we don't do validation because we think we will fail. We do it in case we missed something and might fail.

in the medical industry this typically isn't optional. Your Customer can very well also help you with the validation plans.

[Keep Smiling]

Thanks for the information & definitions, that gives me a good start. Does the FDA have specific forms to complete for the IQ, OQ, & PQ; or do I need to establish them?

[Ajit Basrur]

Originally Posted by Keep Smiling

Thanks for the information & definitions, that gives me a good start. Does the FDA have specific forms to complete for the IQ, OQ, & PQ; or do I need to establish them?

No, FDA does not have specific forms and you have establish yourself.

I suggest you should have a procedure on these Qualifications and Validations with a template for IQ, OQ and PQ.

Good Luck

[Gert Sorensen]

Aside from all the good advise above, here is some food for thought:

Is the process running smoothly now? Is it already validated?

Moving a machine or a production line can be a nightmare! Don't go into this with your eyes shut....

I have seen a machine being moved all of 100 feet - simple operation - and it took us 8 (eight!) months before it produced acceptable products again. We did not have the sufficient knowledge of the machine and of the surroundings.

Assuming the process is running smoothly: If I were you I would start by establishing every conceivable aspect of the surroundings as they are today.
How is the:

• Humidity?
• Pressure?
• Temperature?
• Lighting?
• Current
• Waterflow/pressure/temperature?
• Other machines nearby? What do they do?
• Does this change with the seasons?

etc. etc. etc.

When you have established everything you can think of relating to surroundings then move on to the machinery. Establish everything about it, you will need to know it.

Why will you need this? Because that when you set up your line somewhere else and it does not work then you will need to find the fault that is there somewhere, and knowing everything about the environment where it did work is a good first step to fault analysis.

It is also a good basis for your IQ. When you know what you need from the surroundings then you simply test as part of your IQ to make sure that it is allright.

[chris1price]

The GHTF document on process validation (SG3/N99-10) makes a good starting point for understanding medical device validation. http://www.ghtf.org/sg3/sg3-final.html

[Adam S]

In my organisation, the starting point of any project is the Risk Assessment stage - it is here that the potential need for process validation will be raised.

Historically, we have been quite good at conducting effective validations - where we have been not so good is getting that Risk Assessment process live and "in the muscle" to use a nasty corporate term. Once RA is part of working life and business planning, you're much more likely to control your processes well