Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,
I recently received a request about the possibility to skip process PQ as our customers are in desperate need of our product and instead carry out temporary 100% visual inspection of the products that are shipped. The idea is then to carry out the process PQ runs at a later stage when our customers have been able to stockpile a bit. The reason this comes up is that our PQ runs will be very extensive.
My initial thought is that this is off the table because I can't find anything that suggests we can make an exception to doing a full process validation.

Do you have any experience in dealing with a similar question, alternatively if you have knowledge of how to handle the question from a QA/RA perspective? Any alternative ways to approach this instead of doing a 100% visual inspection. 

A little context: Works for a manufacturer of a class 1 medical device that is intended to be packed together with a drug as a combination product at our customer and then sold on the US and Japanese market.

Thanks in advance.

Start with the conditions that drive the need for process validation. When you cannot or do not fully verify the process output, then you need process validation. The "cannot" condition usually involves a destructive test such as testing each product for sterility. The "do not" condition usually means a sampling plan where you don't check each item in the lot.

If you do 100% visual inspection to fully verify, then you don't need process validation. This is a good solution in the short term.

The second point is IQ/OQ/PQ. There are no regulatory requirements to use this method; it is only tradition. The requirement, using the 820.75(a) language, is "validated with a high degree of assurance". This is assurance that the process produces only conforming material.

There are lots of ways to get there. One uses the data you collect from the 100% visual inspection. If you know the process input parameters and record the nonconformance rate from the inspection, then you have collected the data to provide a high degree of assurance.

I infer that at some point your inspection will shift to a lot attribute sampling plan such as Z1.4 or c=0. Understand the OC curve of sampling plan and show that your process performs no worse than the sampling plan.

Penultimately, if you use the IQ/OQ/PQ model, the product produced after successful OQ is shippable. There is no requirement to complete PQ before shipping product.

Lastly, if you have very extensive PQ runs, you may not have set up the approach correctly. The work is in the OQ phase where you set the allowable values for the input parameters. If the process operates in that parameter space, it produces conforming material. PQ is only a check.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 13-Dec-2022 05:42
From: Anonymous Member
Subject: Thoughts on skipping PQ

This message was posted by a user wishing to remain anonymous

Hi,
I recently received a request about the possibility to skip process PQ as our customers are in desperate need of our product and instead carry out temporary 100% visual inspection of the products that are shipped. The idea is then to carry out the process PQ runs at a later stage when our customers have been able to stockpile a bit. The reason this comes up is that our PQ runs will be very extensive.
My initial thought is that this is off the table because I can't find anything that suggests we can make an exception to doing a full process validation.

Do you have any experience in dealing with a similar question, alternatively if you have knowledge of how to handle the question from a QA/RA perspective? Any alternative ways to approach this instead of doing a 100% visual inspection.

A little context: Works for a manufacturer of a class 1 medical device that is intended to be packed together with a drug as a combination product at our customer and then sold on the US and Japanese market.

Thanks in advance.