Chromatography Forum

I refer to the Topic "is amc required" posted on Tue Feb 21, 2006 1:07 pm. I am in a same situation of funds crunch. I am ready to opt for a third party AMC for breakdown and for getting OQ/PQ reports. But the instrument manufacturer's service engineer says that 3rd parties do not have a OQ/PQ certification from the manufacturer and hence their OQ/PQ report is invalid! Can you pl. clarify with more information in this regard?

Best Regards,

Sivaraman

I tried to find a solution too. I asked our GMP consultant and here is his result:
If you have prescribed SOP, where is this possibility written, you can do this. Even if you have prescribed SOP in such manner, you can do it yourself. But you must use calibrated instruments (flowmeter, thermometer, standards,...).
We passed FDA audit, local CAuthorities audits and all customer audits with this approach.

For equipment Annual PM (Preventative Maintenance) and Calibration, this can be very different for depending on the type of equipment, your needs and the vendor you are using. For analytical HPLC in a GMP environment, I have always had a complete service plan with the original equipment manufacturer (this is the easiest to justify to an auditor).

However, this is usually overpriced and I have had a lot of questions and justification memos for accounting.

Sometimes this is "Massive Overkill" - I watched the vendors IQ/OQ for a new process chromatography system. It required 2 technicians a week to crawl inside and verify the serial # on every computer chip inside the control box. This was to prove that the Equipment Specification list from the factory was correct, before they started testing to make sure everything works. Needless to say this cost many 10's of thousands of dollars. Was this "money well spent" for a drug in Phase 1 clinical trials????

I have also seen some Annual Calibration that is a total farce, and just duplicates what I do as a daily system suitability check.
But I got "a sticker" on the instrument, and that is what is important - RIGHT?

There are 3rd party service engineers (or In-House Metrology) that can do everything required as well, or better, than the OEM for a much more reasonable price. This requires some oversight and understanding of what needs to be done. Make sure there are documented protocols and acceptance criteria.

As with most issues in this industry:
- Be able to justify scientifically what you do.
- Justification should be a "Risk Based" decision, focused on patient safety and worst case scenario.
Sometimes, the minimal approach is all that is needed - overkill does not add to patient safety (just fat reports and large billing invoices).
- Document everything.


Most Important, keep things based on reality and don't forget to have fun.

I sincerely thank Mr.Sadilek & Mr.Rande for sharing their knowledge.

I see you used the term OQ / PQ for a service engineer performing an annual PM (Preventative Maintenance) and Calibration.

I wanted to comment on: IQ / OQ / PQ .

These terms are usually used in reference to Equipment Validation, as part of a Manufacturing Process Validation. (See : FDA - Guideline on
General Principles of Process Validation, May 1987)

Installation Qualification (IQ) - Detailed description of the equipment including its utility requirements. As appropriate, show that the equipment is supplied with all utilities it requires (such as electricity, steam, water, compressed air, etc.)

Operational Qualification (OQ) – Show that the equipment, as installed, is operational to all specifications of the manufacturer.

Performance Qualification (PQ) – Show that the equipment can be used for the job you are using it for, as part of the manufacturing process.

The way I like to summarize these concepts is:
You just bought a new sports car – IQ / OQ shows that it is just what you wanted and runs great.
Now comes the PQ …. You need to carry your son’s little-league team on your night for the car-pool !!! (It might meet all vendor specifications, but not be the right tool for the job).

Note: The terms IQ/OQ is commonly used in the industry (and accepted by the FDA) as part of a validation package for analytical equipment and/or Software, but you should not use the term “PQâ€

Most equipment manufacturers have a formal training program for their service engineers and a copy of this is included in the OQ documentation. (If you use a 3rd party vendor, it is your responsibility to show that you hired someone that knows what he is doing).

Don't let an equipment vendor "bully you" and insist that you will be in violation of GMP/GLP if you use a 3rd party vendor.
I guess it is the same as that new sports car ... your favorite mechanic might be the best for most service, but sometimes only the dealer has the right tools and training for a new model. (Don't let that scare you away from using "the corner garage" but make sure he knows what he is doing).

I strongly agree with Mr. Rande, this gives an appropriate answer to sivaraman's query & thank him for providing valuable information on IQ/OQ & PQ with a simple example.


Regards,

Thank you Rande for your comment. Excellent description of IQ/OQ/PQ!

As you wrote, hired technician must be well informed about used instrumentation and vendor qualification practice.
Our experience:
Don't forget to cover up parameters, which are outside of standard qualification procedure. For example: You are using column thermostat at 50°C but verified range is only +20°C - +40°C, verified injection range is 1 - 25 ul but you are using 50ul!
Be prepared for inquisitive questions of inspectors. Carefully read through supplied documentation and be prepared to show to inspectors where is which value stated and how is calculated. Lot of work but you become real HPLC specialist.