SBS - The Best Value in QMS software

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

MrTetris

Involved In Discussions
#1
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.
 
Elsmar Forum Sponsor

JJ_FDA

Involved In Discussions
#2
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

Super Moderator
#3
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

Trusted Information Resource
#4
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

Involved In Discussions
#5
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

Problem Solver
Staff member
Moderator
#6
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

Involved In Discussions
#7
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

Problem Solver
Staff member
Moderator
#8
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

Involved In Discussions
#9
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).
 
Thread starter Similar threads Forum Replies Date
L Job Aids for administrative staff in GLP environment Document Control Systems, Procedures, Forms and Templates 6
J GLP accreditation for mechanical tests of medical device? Other Medical Device and Orthopedic Related Topics 1
A Information on good laboratory practices (GLP) for the non-medical or food industry wanted Manufacturing and Related Processes 1
T MDR on Good Laboratory Practice (GLP) - Pg 110, section 6.1 (b) EU Medical Device Regulations 1
J GLP requirements in preclinical study CE Marking (Conformité Européene) / CB Scheme 3
H Do all animal studies have to be GLP compliant? EU Medical Device Regulations 1
J GLP Animal Study - Change number of treatment sites Other US Medical Device Regulations 2
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
P Comparison of OEDC and US FDA GLP (Good Laboratory Practices) Other Medical Device and Orthopedic Related Topics 4
J GLP recognition via SCC (Standards Council of Canada) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
J Blood glucose monitoring device testing - GLP or GCP Other US Medical Device Regulations 1
Y New Draft FDA Guidance for Applicability of GLP in Medical Device Submission Other US Medical Device Regulations 2
Sam Lazzara Summer 2013 - Best of FDA Guidance Documents - GLP Q&A, Clinical Monitoring, MDR Other US Medical Device Regulations 0
F Biocompatibility study conducted in the GLP lab outside Japan Japan Medical Device Regulations 2
N Scope of GLP (Good Laboratory Practices) in different countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Z Getting around GLP (Good Laboratory Practices) with FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G How to get the FDA (GLP Certification) US Food and Drug Administration (FDA) 5
D Do Device Verification Bench Tests need to be GLP? US Food and Drug Administration (FDA) 7
C ISO 17025 - GLP (Good Laboratory Practices) Gap Analysis ISO 17025 related Discussions 8
M GLP (Good Laboratory Practices) Requirement for Sterility Validations Qualification and Validation (including 21 CFR Part 11) 1
AnaMariaVR2 Regulatory References for the Operation, Maintenance and Calibration of GLP equipment US Food and Drug Administration (FDA) 6
B What do we need to do to be certified as a GLP laboratory? US Food and Drug Administration (FDA) 9
I Good Laboratory Practices (GLP) Gap Analysis Other Medical Device and Orthopedic Related Topics 3
S GLP (Good Laboratory Practices) Requirements and Audit US Food and Drug Administration (FDA) 9
M A question arising in my lab in a GLP (Good Laboratory Practice) study US Food and Drug Administration (FDA) 8
S GTP (Good Tissue Practice) & GLP (Good Laboratory Practice) Certification US Food and Drug Administration (FDA) 1
S GLP (Good Laboratory Practices) Certification Body Various Other Specifications, Standards, and related Requirements 10
D "certified" in ISO 19011, as well as IATF required? IATF 16949 - Automotive Quality Systems Standard 4
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 3
B Is labeling on the device itself required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J Scrap Material Scale Calibration Required? IATF 16949 - Automotive Quality Systems Standard 21
K Is Calibration Required for Non-Adjustable Commercial Inspection Devices? General Measurement Device and Calibration Topics 11
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 0
S For Parts Manufacturer Approval (PMA) Is 100% Inspection Required? Federal Aviation Administration (FAA) Standards and Requirements 2
B AS9102 - 3D printing a special tool required for assembly (counterfeit risk?) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
OpExPro AIAG VDA DFMEA Template Required FMEA and Control Plans 2
B PMA Supplement Required? US Food and Drug Administration (FDA) 3
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
S Required tests for Surgical gown US Food and Drug Administration (FDA) 1
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3
B NIOSH Approval for Surgical N95 Respirators - Required testing US Food and Drug Administration (FDA) 2
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
R Green dot required on packaging? Medical Device and FDA Regulations and Standards News 2
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1

Similar threads

Top Bottom