Validation Plan Requirements when moving to a new Plant - Medical Device Industry

[lisawxf80]

Dear All,

My company is Medical device manufacturer.

We are going to move to new plant.

Our facilities include ETO, production with machines, and cleanroom

May I know how many validations have to be covered. And in what areas.

Thanks & Regards,

Lisa

[Marc]

A quick "Bump". My Thanks in advance to anyone who can help with this one.

People Helping People around the world!

Thank You!

Marc

[harry]

In Reply to Parent Post by lisawxf80

...................... May I know how many validations have to be covered. And in what areas. ................

From the good practice angle, the whole process needs validation by carrying out IQ, OQ and PQ. You can use the following document for reference.

[lisawxf80]

In Reply to Parent Post by harry

From the good practice angle, the whole process needs validation by carrying out IQ, OQ and PQ. You can use the following document for reference.

Hi Thanks a lot for the advise.

My current problem is not sure what item to be validated in the whole transfer plan.

Someone had suggested below listed to be validated:

1.Building Equipment Validation
2.Water filter System Validation
3.Clean Room Validation
4.Air compresser System Validation
5.wash soap validation
6.Hand wash Validation
7.Gowning Wash Validation
8.O3 Supplier Validation
9.Packaging Machine Validation
10.Production Validation
11.ETO validation
12. Sterilization Validation


I have no idea whether it is enough or too complicated.

BTW, we have only 2-3 people here to lead this which I think it is almost impossible.

[harry]

In Reply to Parent Post by lisawxf80

....................I have no idea whether it is enough or too complicated. ..................

Looks like a bare minimum to me but I am no expert and lets hear what they have to say.

Meanwhile, here's a related thread: Process Validation - Production Line Transferring to a Different Facility

[somashekar]

In Reply to Parent Post by lisawxf80

Hi Thanks a lot for the advise.

My current problem is not sure what item to be validated in the whole transfer plan.

Someone had suggested below listed to be validated:

1.Building Equipment Validation
2.Water filter System Validation
3.Clean Room Validation
4.Air compresser System Validation
5.wash soap validation
6.Hand wash Validation
7.Gowning Wash Validation
8.O3 Supplier Validation
9.Packaging Machine Validation
10.Production Validation
11.ETO validation
12. Sterilization Validation


I have no idea whether it is enough or too complicated.

BTW, we have only 2-3 people here to lead this which I think it is almost impossible.

Address this as re-validation.
Means that you have these processes validated already and good for you.
Since moving of the machine / equipment is involved, address IQ in the re-validation.
Use all the learning from your process validation OQ and make sure that are still valid. Most likely they will be valid, if the IQ has been addressed well.
If OQ confirms same to already validated parameters, keep off PQ.
Its easy. Re-validation in such cases are with more emphasis on the IQ, and if the previous IQ was good and you are able to replicate the same, your OQ and PQ most likely stands.
Are you moving the plant to a nearby location in the same altitude, or to a different far off location having different altitude, and other climatic conditions ? OQ / PQ would have effects under a move to an other zone.

BTW, we have only 2-3 people here to lead this which I think it is almost simply impossible.

[lisawxf80]

Dear Somashekar,

Appreciate for your advise. Process validation is not a issue for us, the most difficult is the facility and GMP related new validation.

We will move to a new plant which is nearby our current factory.

As it is new, we have to conduct various validation including watering, compressor, air-con, ETO etc.

The above list is provided by former engineer. My confusion now is whether the listed item sufficient or not, or we can just ignore some of them. Is it necessary to have all of them.
And how to conduct the validation, should I do one by one or group them into few validation report.

BTW, our clean room is class 100k.

Appreciate your further advise. Thanks a lot.

Thanks & Regards,

Lisa

[v9991]

I would like to approach the question slightly differently;

If you are moving to 'new' plant then look at it from all the supporting processes which are "relevant&needed&impact" for your product;
(risk assessment is the concept)

for eg., I would like to see your list in broadly two groups..
category 1 : procedure/method/process;
these are not going to affected unless new facility introduces/changes the attributes of any aspects of procedure/method/process
of below listed categories, ETO & sterilization are mandatory activities to be demonstrated; while you need to assess the what new variables (change in water for soap wash, etc., or introduction of new gowning material/procedure at new facility etc.,)

5.wash soap validation
6.Hand wash Validation
7.Gowning Wash Validation
11.ETO validation
12. Sterilization Validation

category 2 : equipment/facility
assuming that they are reinstalled; these ought to be qualified/validated as appropriate.

1.Building Equipment Validation
2.Water filter System Validation
3.Clean Room Validation
4.Air compresser System Validation
8.O3 Supplier Validation
9.Packaging Machine Validation
10.Production Validation (not quite sure what it is, if its process/product, even then it comes under category -2 )

I am not sure about medical devices, but reason/experience of pharma should hold good; i.e., anything which is ""dismantled/re-assembled - transferred/shifted"" equipment(even process) seldom behave well in the new environment;
the point is, it may not-be always adequate *to verify IQ nor is verification through OQ going to provide confidence.
hence an extreme/thumb-rule is ..., if it was required to be validated in current/existing facility then its required in new plant.