Medical device facility validation - Need help

I am working on writing a protocol for facility validation of a medical device manufacturing company and can't find much applicable info for this.

I have the general idea of making sure that the facility can support the manufacturing process. What I am unclear on is how specific this needs to be.

Take the electrical system for example: Does each breaker box need to be addressed individually? For each box, does each individual electrical component drawing off that box need to be addressed?

Besides electrical, water, and air, are there any other systems that I should be addressing?

Does anyone have any sample facility validations they would be willing to share?

Thanks!!

Maybe post more information, as to what type of medical?? Will it need to have cleanrooms, and controlled air?

We manufacture metal implants and instruments using CNC mills, lathes, etc along with a few older, manual machines. We do not sterilize nor do we do the final cleaning on the products. We do have ultrasonic cleaning capabilities and therefore use a de-ionized water system for that purpose.

Hope this clarifies

If you are talking about Facility Validation, its more towards the HVAC (Heating, Ventilation and Air Conditioning) along with Clean Rooms and other utilities going into the clean rooms like Compressed Air, Nitrogen etc.

I would suggest you to start with a Master Validation Plan (MVP) in which you list down all the project deliverables and walk through its completion.

Refer Facility Qualification and Validation as an example.

Btw, IVT has a great book, Facility Qualification

Also plz refer ISO 14644 series of standards.

When our company moved we wrote our facility validation to redo all of our process validations as well as the equipment mentioned above. The thinking was the move may have caused the processes in some way to be different than they were previously.

After lots of thought and reviewing some of the suggested literature, my current thinking is that a facility validation should not encompass processes, rather the VMP should do that.
Our facility is going to be moving in the near future as well, and my thoughts are that I should be able to write a protocol to validate the actual facility itself prior to installing any equipment in the facility.
Then once the facility is validated the equipment can be installed (IQ) and procede in a logical order through the equipemnt OQ and PQ and process validations.
Sound right to anyone else?

Oh, one more thought: If equipment has been successfully installed and the operational qualification is successfull, and the sequence of events and settings of a process have not changed, then why would the process need to be re-validated upon moving equipment?
Seems like if you show the equipment used in the process is functioning the same way in the new facility then the process itself should not be affected. Would love to hear other people's thoughts on this though!

I would agree with the first thought:

Your all encompassing document would be VMP. VMP should include everything that you would be validating such as facility validation, equipment validations, process validations, testing validations etc. etc.

I am conflicted on the second thought of performing IQ, OQ on equipment and if all of that is successful and the settings have not changed; process validation is not repeated. The thought is perfectly logical on its surface and there are no strong counters to it.
The reasons for my hedging are as follows:
a. You would have to ensure equivalence in every aspect of every validation that may have an impact on the process in question. This seems to me like a fairly difficult task
b. Typically if you are trying to establish equivalence, it is very susceptible to gaps which the auditors are likely to find
c. If you are repeating the IQ and OQ , repeating the process validation "concurrently" will eliminate this potential audit pitfall

I would be interested in knowing if anyone has successfully established equivalence in this manner.

Thanks for the responses, they have all been helpful in some way. I still have not heard much about validating a facility though. This is where I am really getting stuck. I should be able to validate the actual facility before putting any equipment into that facility, right?
I understand having to have a master plan and qualifying components of the manufacturing process such as equipment. I am stuck on the facility itself.
Anyone have any thoughts on the facility itself??