Regulatory Open Forum

My company is an IVD manufacturer. This is the second time we are moving to a new facility. We previously performed IQ/OQ/PQ, got inspected by BSI, and passed without any issues. This time, I'm getting push back from the new mfg manager who insists we "don't need to perform IQ/OQ/PQ. I explained to them that IQ is a must because we have to install the new equipment into the new facility. The OQ is to ensure the equipment works with the new utilities and the PQ to ensure the final product meets specifications. What other arguments can I give them?
We don't conduct 100% verification of our finished product.



------------------------------
Carol
------------------------------

Hello Carol,

Tell them they work for a medical device company which is regulated?  Ask them how they would feel if they went to an amusement park to go on a roller coaster and the company decided they did not need to do IQ/OQ/PQ because the equipment is the same, just putting it in a different place.  Sorry I do not have any other words of advice beyond it is a regulatory requirement.  If the equipment is indeed the same just moving to a new facility, there may be ways to minimise the IQ and OQ or even combine them together.  However, if you are not doing 100% verification of finished product, some type of PQ should be done.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Mar-2022 20:54
From: Carol Castillo
Subject: Validation after relocation to new facility

My company is an IVD manufacturer. This is the second time we are moving to a new facility. We previously performed IQ/OQ/PQ, got inspected by BSI, and passed without any issues. This time, I'm getting push back from the new mfg manager who insists we "don't need to perform IQ/OQ/PQ. I explained to them that IQ is a must because we have to install the new equipment into the new facility. The OQ is to ensure the equipment works with the new utilities and the PQ to ensure the final product meets specifications. What other arguments can I give them?
We don't conduct 100% verification of our finished product.



------------------------------
Carol
------------------------------

This message was posted by a user wishing to remain anonymous

Carol,
You are correct, you need to qualify your process at the new facility. You could back up your claims siting the regulation. In the end, you can let him know that you won't/can't authorize release of product until the process has been qualified. The manager presumably knows that IVDs are a regulated product.

Good luck
Original Message:
Sent: 22-Mar-2022 20:54
From: Carol Castillo
Subject: Validation after relocation to new facility

My company is an IVD manufacturer. This is the second time we are moving to a new facility. We previously performed IQ/OQ/PQ, got inspected by BSI, and passed without any issues. This time, I'm getting push back from the new mfg manager who insists we "don't need to perform IQ/OQ/PQ. I explained to them that IQ is a must because we have to install the new equipment into the new facility. The OQ is to ensure the equipment works with the new utilities and the PQ to ensure the final product meets specifications. What other arguments can I give them?
We don't conduct 100% verification of our finished product.



------------------------------
Carol
------------------------------

Carol,

I am in total agreement with all the responses received.  These are regulated products that require process validation per the regulation.  I completed a manufacturing site move two years ago and process validation was the main requirement for releasing the product for distribution.  You must demonstrate equivalence to what was originally approved/cleared by the regulators.  As part of the site certification, the validation reports were heavily reviewed by the regulators.  We also had a former (very conservative) FDA Inspector tell us that FDA would expect to see design V&V conducted on sample products from the new production lines.  I believe this to be a little excessive, but since it helped establish equivalence it was done.  At the very least you must conduct process validation.  

Hope this helps

------------------------------
Bruce McKean
Director of Regulatory
Rimsys Inc.
Pittsburgh, PA
USA
bruce.mckean@rimsys.io
------------------------------

Original Message:
Sent: 22-Mar-2022 20:54
From: Carol Castillo
Subject: Validation after relocation to new facility

My company is an IVD manufacturer. This is the second time we are moving to a new facility. We previously performed IQ/OQ/PQ, got inspected by BSI, and passed without any issues. This time, I'm getting push back from the new mfg manager who insists we "don't need to perform IQ/OQ/PQ. I explained to them that IQ is a must because we have to install the new equipment into the new facility. The OQ is to ensure the equipment works with the new utilities and the PQ to ensure the final product meets specifications. What other arguments can I give them?
We don't conduct 100% verification of our finished product.



------------------------------
Carol
------------------------------

This message was posted by a user wishing to remain anonymous

Carol,
The need for re-validation is specified in the site Master Validation plan (MVP) if the site has one. If the site does not have a Master Validation plan then one needs to be generated . The MVP should include the list of all processes requiring validation and specifies the frequency of the validation and the changes that trigger re-validation for a process or equipment. This information may also be found in the Design file.

Original Message:
Sent: 22-Mar-2022 20:54
From: Carol Castillo
Subject: Validation after relocation to new facility

My company is an IVD manufacturer. This is the second time we are moving to a new facility. We previously performed IQ/OQ/PQ, got inspected by BSI, and passed without any issues. This time, I'm getting push back from the new mfg manager who insists we "don't need to perform IQ/OQ/PQ. I explained to them that IQ is a must because we have to install the new equipment into the new facility. The OQ is to ensure the equipment works with the new utilities and the PQ to ensure the final product meets specifications. What other arguments can I give them?
We don't conduct 100% verification of our finished product.



------------------------------
Carol
------------------------------