I am trying to find a clear definition on commissioning that shows where it distinguished itself from installation qualification. To better understand the difference between the two above, could you give me some examples which tests would one perform during IQ which are not yet performed during commissioning?
Hi @gokeeffe ,
Can I say that commissioning is the pre-qualification (before IQ) step to verify the ground installation, utility connection, P and ID, and may be few safety test/alarm test based on the need, which may or may not get documented.
I mean commissioning is the step before qualification , to give green signal to proceed for IQ…
Is it so ??
Your confused. A piece of equipment must be commissioned and then qualified when installed in a manufacturing process train. For instance, in terms of an ‘installation qualification (IQ)’ you plugged it in an get a green light. For the ‘operational qualification (OQ)’ of a centrifuge it can only perform 0-60,000 rpm. But it fails because the drug product needs 70,000 rpm (though it is still commissioned).
I’d like to try to help a bit - and there a LOT of different strategies on this. It really is based on your company, and the complexity of the system.
A complex system will have bugs and issues. Commissioning is the process of finding and fixing these bugs. So yes, for complex systems commissioning would show that you are not ready to qualify. At this point, qualification is pretty much guaranteed to succeed. Please be aware that commissioning could be pretty similar to qualification in scope and detail, but commissioning might look at different things too. For example you might commission an air handler (very detaiiled). But then during qualification you only qualify the differential pressure control, and maybe temperature/humidity (if your product is sensitive to temperature and humidity).
For simple systems, (like a balance/scale), I would not do any commissioning. This is an off the shelf item, and there really aren’t any issues/bugs to find and fix. I would simply go into qualification.
Also, some companies treat commissioning as a GMP activity, with deviations QA approval, change controls, etc. My personal opinion is that this defeats the purpose of commissioning which is to find and fix issues. If you’re writing deviations when you find an issue, then you hinder commissioning for both speed and cost. Having to write deviations for commissioning issues is too large an encumberance. (By the way, I will probably get people who disagree with this statement - that is why I stated that it depends on your company and the complexity of the system).
I’ve heard it said that qualification is a walk down memory lane, and not a path of discovery. I would state that commissioning is a path of discovery - treat is as such.
But to answer your question overall. Commissioning is a good activity to ensure you are ready for qualification.
What system are you asking about? What are you commissioning and qualifying? This could help the forum answer your question about what the differences are between commisioning and qualification.
Using the following ISPE Documents:
ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities: Volume 5, Commissioning and Qualification;
GAMP 5: A Risk Based Approach to Compliant GxP Computerized Systems;
ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment;
and ASTM E2500-07, Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
You might complete all test scripts in the FAT Test, SAT Tests or Commissioning Protocol, and just need to show a leveraging table (trace matrix) of where IQ and OQ testing was done during FAT, SAT or Commissioning. We need to test thoroughly, but do not need to repeat the testing unnecessarily. Put a detailed leveraging strategy in you C&Q Plan and Val Plan and you will save countless hours of time on your project.