Dose Audit Requirements

[GLW79]

Hi.
This is my first post and I'm hoping someone somewhere will be able to help me on the above subject.

I've recently been asked by a new customer if we carry out quarterly dose audits on our products, which we don't. However this particular customer wants us to carry out this function on their product, but I have been informed by my NFB that, "we do not have to claim compliance to ISO11137".

So my question is, which route should I be taking? Conducting dose audits is a very costly exercise and is it really required when we have over 7 years worth of product data (bioburden) and approx 40 VD max studies carried out on various product families and suppliers.

If somebody could shed some light on this matter is would be much appreciated.

Thank you

 

[rclanzillotto]

It is not unusual for customer requirements to exceed regulatory requirements. If that is the case here ( I can't speak to whether it is) then you need to negotiate this with the customer. Find out what drives their requirement and see if there are less expensive ways to address it.

 

[Ronen E]

Hi.
This is my first post and I'm hoping someone somewhere will be able to help me on the above subject.

I've recently been asked by a new customer if we carry out quarterly dose audits on our products, which we don't. However this particular customer wants us to carry out this function on their product, but I have been informed by my NFB that, "we do not have to claim compliance to ISO11137".

So my question is, which route should I be taking? Conducting dose audits is a very costly exercise and is it really required when we have over 7 years worth of product data (bioburden) and approx 40 VD max studies carried out on various product families and suppliers.

If somebody could shed some light on this matter is would be much appreciated.

Thank you

After 4 consecutive successful dose audits you can justify a frequency reduction to once a year. The details are all in ISO 11137.

 

[Denis]

After 4 consecutive successful dose audits you can justify a frequency reduction to once a year. The details are all in ISO 11137.

I agree, but you also have to demonstrate that the bioburden is ni control.

This can sometimes be difficult, and lead to discussions about the sample frequency and sample size of the bioburden tests.

For me, it has been difficult to prove the bioburden is in control.

 

[Ronen E]

After 4 consecutive successful dose audits you can justify a frequency reduction to once a year. The details are all in ISO 11137.

I agree, but you also have to demonstrate that the bioburden is ni control.

This can sometimes be difficult, and lead to discussions about the sample frequency and sample size of the bioburden tests.

For me, it has been difficult to prove the bioburden is in control.

Fair enough.

The question is, was it just difficult to prove, or was it because bio-burden is actually not under control?...

 

[Denis]

Good question......

The issue for us is that all the raw material is bought in from outside suppliers, some don't have any understanding of bioburden and what it is.

Therefore, the supplier manufacturing conditions, storage conditions and time held in stock are all quite variable.

Generally the bioburden isn't too bad, but the problem is bioburden spikes (which will always be difficult to justify).

Personally , I'd say it would be difficult to justify the bioburden being under control when spikes are present - as these display values outside of the "norm".

I suspect that the OP may have the same situation, and this makes the 4 consecutive rule almost impossible to justify. This has the impact of making the dose audits a costly ongoing exercise.

Be interested to hear some detail from GLW79 on his actual situation though.

 

[amanbhai]

What is that bio burden? Just curious!!
Thanks

 

[Kees Fremery]

Dear GLW79

I understand you performed many VDmax studies and did not continue with the dose audits.
However if your customer has these requirements you need to do something. There might be no need to perform all dose audits immediately I think.
I have had the same issue with one of my customers. I think there is a good option with using Bioburden data for the coming stragegy.
But anyway, you need to invest one way or the other. And costs for dose audits don't need to be that high, depending on the number you must think of about EUR 800.=
I am willing to assist in this, feel free to contact me.

Kind regards,
Kees