Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD?

[MrTetris]

Hi all,
I admit that I am completely new to this topic (biocompatibility and good laboratory practices in general), so I hope to find some help here.
We need to perform a cytotoxicity + soil residuals test on a externally communicating device with limited patient contact (i.e. ≤ 24 hours).
We referred to a test lab, and with a bit of surprise we received this question (from the lab itself): should the lab follow GLP? (of course, price would change if we allow them not to follow GLP)
Now, to be on the safe side from a quality point of view my answer would be "yes, of course", but since it is money that makes the world go round, I need to bring some tangible evidence to my colleagues to support my answer.
Why (from a QA/RA point of view) should we ask the lab to follow GLP for such a case?
Where is it recommended/prescribed?
Any suggestion can be very valuable.

 

[JJ_FDA]

If the data will be submitted to a regulatory agency as part of the approval package for your device, your answer is likely to be "yes." You should probably talk to the agency in question.

 

[planB]

Cytotoxicity testing is typically done in the framework of ISO 10993-1:2018, which says in section B.4.5.2:

Good laboratory practice
[...] Quality systems controls applicable to non-clinical testing are known as Good Laboratory Practice (GLP). GLP studies are carried out to defined quality standards in laboratories that are accredited in line with an internationally implemented governmental scheme. Typically studies will be conducted under a laboratory quality system compliant to ISO/IEC17025 or an equivalent standard.

The latter (i.e. ISO 17025 accreddation) may also be the preferred evidence that you could ask the lab for the test on residual soil.

HTH,

 

[chris1price]

As JJ said, if you are going to use the report for any GMP or regulatory submissions, it should be to GLP standards. The last time I can recall asking a lab about the question, they said if non-GLP, the testing would be the same, just that the report and raw data would not be reviewed by managers.

 

[JJ_FDA]

The last time I can recall asking a lab about the question, they said if non-GLP, the testing would be the same, just that the report and raw data would not be reviewed by managers.

Generally, any pricing and compliance differences are related to the involvement of a quality assurance unit to inspect the different phases of work; qualification of equipment, supplies, and personnel; requirements for archiving of materials (documentation, samples, etc.); and a premium for doing regulated work.

 

[Ronen E]

First, I'm not sure what you refer to by "soil residuals". It's not part of the bio-compatibility framework I'm familiar with (let's hope it's not early-onset dementia ).

I remember reading somewhere that GLP compliance is a must for anything you want to submit to the FDA; can't remember where, but you might be able to track it yourself (if relevant to you) with a bit of online diggin'.

For ISO 10993 testing I wouldn't engage a lab that isn't ISO 17025 accredited anyway, which covers GLP.

 

[MrTetris]

Hello, I have an update that could give some additional interesting info to you as well.
Indeed, as many of you indicated already, FDA guidance ( https://www.fda.gov/media/85865/download ) suggests to be GLP compliant:
"Any in vitro or in vivo biological safety experiments or tests should be conducted in accordance with recognized Good Laboratory Practice (GLP) regulations24 including, but not limited to, the assignment of competent trained staff in the conduct of biocompatibility testing".
Therefore, in regards to cytotoxicity test, our lab will have to follow GLP.
My confusion arose from the fact that it is not so clear whether or not GLP is required for MD sterilization validation (you can find plenty of discussions on internet on this topic). In that case, GLP does not seem to be strictly required by FDA.

 

[Ronen E]

IMO "Any in vitro or in vivo biological safety experiments or tests" covers "MD sterilization validation" too (and they did use the "including, but not limited to," phrase with the biocompatibility example).

You can't validate sterilization without sterility tests.

 

[JJ_FDA]

My confusion arose from the fact that it is not so clear whether or not GLP is required for MD sterilization validation (you can find plenty of discussions on internet on this topic). In that case, GLP does not seem to be strictly required by FDA.

GLP covers any safety testing done in non-human test subjects (e.g., cytotoxicity) for the purposes of regulatory approval. GMP covers any process validation work that you do (e.g., device sterilization).