Hi All :bigwave: Thanks in advance for any input anyone has.

I was curious if anyone had ever seen a sterility validation shared by two different companies. That is both companies products fall within the same "product family" (meeting the requirements of ISO 11137-2, 4.2). Also what would the FDAs thoughts be on this?

I have been asking all around and no one has been able to give me any help on this matter so I thought maybe some of the folks on the cove could :cool:

Any takers ???

This is my take on the situation:

Even if the products are very similar and potentially the validation of one could apply to the other, the issue arises of who is in control of the validation. If you were using another companies product validation to support your sterilisation, you would not only have to establish rigorously, with evidence, that the products are similar enough, but also have to do an audit of the other companies processes and quality system to ensure that it meets your requirements.

Simon

I was curious if anyone had ever seen a sterility validation shared by two different companies. That is both companies products fall within the same "product family" (meeting the requirements of ISO 11137-2, 4.2). Also what would the FDAs thoughts be on this?

I have been asking all around and no one has been able to give me any help on this matter so I thought maybe some of the folks on the cove could :cool:
This used to be fairly common practice when the sterilizer used Process Challenge Device (PCD) loads. The validation report would be generic for all product families that could make up the final validated load, with each individual contributor receiving this report, plus a tailored report justifying, using a documented equivalence process, the choice of the PCD as something representative, or more "worst case", that the product under validation. This approach is normally acceptable to an inspector, as long as you have reviewed the report and concur that the PCD is appropriate. If the PCD has an occluded 5 metre tube with an ID of 1 cm and your product has a 20 metre tube with ID 0.3 cm then you are going to have a very hard time justifying equivalence! As usual, it is up to you to demonstrate the acceptability of the validation.

The only situation which might make sense for this is if you are relabeling the product (and it is the same product otherwise). There are too many variables for 'similar' products that could change independently of each other because the decisions are being made by two different companies. If one of the products is suddenly significantly altered (change in weight/density, change in materials, change in manufacturing conditions), that product will no longer be covered by the original validation and you are back at square one.

Now that I think of it, manufacturing conditions make this scenario almost impossible. Two companies can make an identical product with identical equipment (and identical tolerances). If one manufactures and packages in a cleanroom, and the other does not, the validations would be completely different for the two items based on bioburden levels. Even if you can prove equivalent conditions and bioburden, you have to then prove at each dose audit that biodurden levels remain consistent between the two companies products (or the validation of BOTH products may be jepeordized.)

This is a huge minefield. Two separate companies i.e.two separate manufacturing locations cannot share a sterilization validation between them for similar or even identical products.
FDA makes it clear that even if the same product is manufactured by the same manufacturer in a relocated facility, validations have to be repeated. Then you add the complexity of whether you are using the same sterilizing facility. If you are not, then you have to establish equivalence there also.
The complexity is exponentially increased again by which method is employed in the validation; i.e. method I, method II or Vd max, the physico chemical characteristics etc. etc.
It would be much easier to conduct an independent validation.

I agree with Dash.

It is better to have independant validation. (can take VD max substantiation for 15 or 25 kGy based on your product). I did the same.


Raghu.