Facility Closure

Hi there
Does anyone have any good information on the validation requirements when closing a facility???

Why is the facility being closed? Is it to be sold (ie the company has gone bust or the location shut down to save costs), is it to undergo major modifications or is to be demolished as it is no longer required?

I would not think that there would be any validation requirements - why would you want to validate something you are shutting down? I suppose that you might want to do final calibration checks on key instruments just to show that they were in calibration right up to the end. If you are selling equipment on, the BUYERS will be responsible for validating it prior to use.

However, I would think that the main requirement will be a Health & Safety/COSHH assessment of the facility. There will be a need to list what chemicals were handled (and how) in the facility during its the lifetime. This would be needed for the next users, for the engineering team or for the demolition team breaking into air conditioning ducting, extraction ducts or voids know what “nasties” to expect and take appropriate staff and environmental protective measures.

thanks for the reply…
Production is to stop in the facility (was used to manufacture clinical trial material) and all the systems will be switched off but it won’t be demolished as of yet, equipment will be left in place etc. the reason I ask about validation is that the requalification schedule for the year won’t now be executed but batches will be released to the clinic during that timeframe

Providing the equipment was “in qualification” during the manufacturing campaign, I cant see that it should be a problem providing all validation documentation has been completed and approved for that period.

The important thing is that you have a requalification plan which can be put in place if needed. The regulatory authorities will want to see that you have thought about requalification for when it is next required.

Actually, there is a ton of work that needs to be done. You are closing out the validation life cycle for your equipment but on a grand scale. Typically, this means decommissioning. Decommissioning plans need to be written and followed. At least that is what we did when we closed a pharmaceutical manufacturing facility. Just follow what you wrote in your VMP.