Continuous Monitoring System Performance Qualifications or Test SOPs: How to Meet Your Quality Management System Requirements

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Paul Daniel
Sr. Regulatory Compliance Expert
Dec 18th 2013
Industrial Measurements
Life Science
Science & Sensing Technologies

This week we received a question from a blog reader on PQs for environmental monitoring systems.

Comment

Rocio Aojalla

Feb 05th 2018
Please, I need to Qualify my vehicle for transportation of product between 15 to 25 °C
I do not know how many time it is necessary to makes the test or for how many hours, for the no load test and load test please could you tell me with legal references there is.

Best Regards

Rocio Aojalla

Paul Daniel

Feb 06th 2018
Dear Rocio:

There is some good guidance around this topic from the USP, which I will share later.

As far as actual “legal” regulations, this will depend very much on which countries you do your shipping and transportation activities in. The GDP (Good Distribution Practices) vary widely from country to country. My best recommendation is to look at the regulations for both the country(s) where you manufacture your product as well as the countries that receive your product. Start there and you will be able to tell what set of regulations legally apply to you.

Now back to guidance. For a starting point, try the USP Revision 36 Chapter <1079>. It touches on qualifications of vehicles for transportation of pharmaceuticals and medical devices.
https://pharmacy.ks.gov/docs/default-source/default-document-library/ups-36-good-storage-and-shipping-practices.pdf

In the end, much of this boils down to your expected use cases. If your products will be in the truck for no more than 24 hours, then should do your test for at least 24 hours. This duration should be the same for both loaded and unloaded conditions.

Good luck and thank you for reading our blog!

Paul Daniel

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Dear Paul, I’ve reviewed several of the Vaisala validation webinars, but I wanted to ask a question specific to my facility's continuous monitoring system. Are there canned PQ scripts that we can adapt to our system? I would like to perform a robust valid

Dear V, First off, thank you for checking out our webinar series and for reaching out! We do not currently have any “canned PQ” scripts.
However, you will find this very easy to do on your own. If we do a quick risk assessment with the standard parameters (likelihood, severity, and detectability) it becomes clear that a monitoring system software, even one as adaptable as Vaisala's viewLinc, has relatively few critical functions:

The critical elements are simply:BLOG-IMAGE-SAMPLE-VAISALA
1. Reporting of data (so that we can make GMP decisions based on the reported parameters.)

2. Automatic generation of reports (this only if your Quality System has integrated automated report generation as part of your procedure.)

3. Alarming - Thresholds and Communication (this only if your Quality System has proceduralized analysis of alarming as part of your release criteria. However, you may want to include it anyway as it can protect product so well.)

Most other system elements are either less important or non-configurable (and so are tested by OQ or system testing by Vaisala). If you integrate them into your Quality Management System, you might consider the following elements critical as well:
1. Notification schedules
2. Alarm Acknowledgement Comments as a vehicle for team communications
3. Calibration Alarms

So, my approach  is to make a generic PQ protocol that includes worksheets with blanks that you can fill in with the required parameters for the given location/report/alarm. Include in your worksheets parameters such as delays, thresholds, notification recipients. You should be able to access this right from your Monitoring SOP or Policy. If you don’t have a policy or SOP that states these values, then you probably don’t have a process to validate/PQ.

Another way to play this is to skip the PQ, but have an annual alarm testing SOP. You can use this SOP as the vehicle to test your alarms (which you should do annually anyway) and simply verify that the procedure is in place and has been performed within the last year.

These are just a couple ideas to guide you in this process and I am happy to review anything you put together and give input!

The basic process is to challenge each location/alarm/report. Use parameters for each function that are included in your existing Quality Management System documents. Often we run into customers that want to do a PQ, but have no process to validate because they haven’t integrated the system functions into their Quality Management System.

Let me know how I can be of further assistance and good luck!
Best regards,
Paul