System suitability

[B_rogen13]

I was wondering if anyone had any suggestions or knew if this topic is published anywhere. We have a gc method that requires system suitability to be established 24 hours before our drug is tested. What would void this system suitability before the drug product is actually injected?

We work with a contract site that establishes system suitability then changes the gc method to inject a different drug product then switches back to our method before injecting our drug product. They swear that the flame does not go out in between changing methods and that the flow of gases is not interrupted. Is this acceptable for a GMP facility?

[chromatographer1]

If I were a Government inspector I would not be happy with your practices. Not at all.

Any injections not pertaining to the method or any amount of time other than
"immediately without delay sample will be tested" would be completely unsatisfactory to me.

You would receive a letter.

But, why not ask someone in the government? Would that not be the best path?

best wishes,

Rod

[Johnny Rod]

Sounds like you have different interpreations of what system suitability is. As Rod says, in GMP you'd be hard-pressed to use a system suit from one run on another, unless maybe your sample can also act as the system suit (e.g. peak shape or plate count checks). The original system suit is then more of a preliminary check. It's a bit convoluted though and you're at risk of being filled in by an inspector (again as Rod says). If the lab injects the system suit just before your samples, this takes no more time overall than injecting it the day before.

[B_rogen13]

This isnt our common practice. This is a contract lab trying to get away with doing this to save them time.

Whenever we perform GC analysis in my lab we perform the system suit and then the next injection is the sample with nothing in between.

The contract lab we are working with makes our drug and than another and to save time they perform our system suit and then inject the other product and then back to our product.

I was wondering if there is anything written that I can send to prove this in not acceptable.

[chromatographer1]

I would suggest a termination of contract. You don't have to prove anything. You are the customer.

Then find another lab.

This usually works wonders.

best wishes,

Rod