Equipment IQ/OQ/PQ required when you have 100% product inspection?


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My stabber explanation of our business...

We are doing contract fermentation of biologics some of which may go to customers who, after extract and purification, may used the resulting material in in invitro diagnostics precut or things like vaccine production... So while we have no requirement to be 13485. Certain types of customs that buy such prefer being from a company that is 13485 certified... so we going for that (Phase 1 mid April, Phase 2 mid May)

With the contract fermentation we wind up doing something new almost every week... so while we do fermentations every week, they are rarely exactly the same process...

Given what we may we make (single homogeneous batches or cell suspension or cell paste), we have 100% inspection off each batch, so there is to requirement for process validation... In that case is there a requirement for formal IQ/OQ and most specifically PQ?

And as we started doing this before we were even ISO9001 certified, and the equipment had already been in use or several years fro fermentation before we turned to contract manufacturing... So we don't have documented IQ/OQ/PQ but we have plenty of evidence that conforming product is made with them... but not the same product...

With contract manufacturing we do fermentations to produce a new a "product" almost every week, and while the overall processes are similar, they are not the same process.

Given that the only regulatory we are under things like the EPA, OSHA, State regulations etc, we are hoping that for the existing equipment (which does have maintenance and calibration records ) we will be OK without IQ/OQ/PQ ...

For new Equipment we see value in doing IQ/OQ but in our environment I'm not sure what PQ would be and do we even need it?

None of our equipment is dedicated to a single product ... while IQ/OQ make sense, PQ I'm not sure of... between 100% verification and it not being dedicated to a specific product I'm not sure it's required.

If we need to do PQ can it be done on batches (that pass) which we sell before a PQ is finished?

Of course , particularly with biologics, and particularly for contact manufacturing , product can fail for reasons that have not nothing to do with equipment performance, and I'm not sure what a protocol for that would look like, as we often don't know exactly what we will be naming until the last minute.

Also we are working on creating our own products (and yes we are going for design) and when the those come to fruition we will make the use the same equipment and still likely not be single purpose (we woudl make them to order and still be doing contract manufacturing)...

So any feed back on if in our situation PQ (And an SOP for it) is required to get certified for 13485 would be greatly appreciated.


John Predmore

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100% inspection means you measure every batch. It doesn’t mean measure every possible characteristic.

The list of characteristics measured in Equipment Qualification and Process Validation are way more extensive and comprehensive than the subset tested in product inspection. IQ typically addresses maintenance and cleaning ability, which are important to biologic quality but may be only remotely evaluated in product inspection. An OQ study often includes process optimization, which goes beyond what are often pass/fail results from inspection. A PQ study may include consideration of process throughput, such as machine uptime, changeover time and other aspects beyond product inspection, per se. IQ/OQ/PQ serve to validate a production process, not only the equipment, not only the product.


Involved In Discussions
Thanks John,

As i said IQ and OQ make sense to me but what do you do for PQ when you are essentially making a different product every week?

We mostly make enzymes and either we or our customer for contract work, will do assays to determine biological specific activity (functional test as well as identity), purity, gels for MW and purity, and some times RP HPLC for for identity and purity....
Using risk based thinking that seems to be reasonable to say...

Now when we develop our own products during V&V we can do some of that.

- Karen
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