Dear all,
i'm searching for the criteria that have to be fulfilled for animal experiments in order to adhere to "good laboratory practice" (or is it GCP when working with animals?).
I am now totally overwhelmed by all the information out there. Can anyone with real life experience point me to some official guidelines please?
Best,
Juliane
Thank you, this is a good starting point. Any ideas on what is absolutely necessary if you want to get a medical device approved at the very end? I always end up with the ISO on biocompatibility. Is that all?
Hello Juliane,
The idea of a GLP study is to control every aspect of it as thorough as possible.For an animal experiment this inlcudes for instance:
- to stick to official guidlines on animal care, housing and welfare
- to obtain equipment from companies that ensure a high quality standard
- to use standard operating procedures
etc.
There are guidlines for the documentation of animal experiments, the ARRIVE guidlines (https://www.nc3rs.org.uk/arrive-guidelines), which are very helpful to read in advance. When know what you should report when publishing your data, you know what you need to record during your experiment.
Best, Laura
Dear Juliane,
In Europe the animal experiments are regulated by the Directive 2010/63/EU.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32010L0063:DE:HTML
It will be necessary to aproach the Animal Welfare Body of your University and I am sure they will help you to find detailed information in your particular case of experimental design.
If you would like to have detailed information about the care of laboratory animal please read the Appndix A of ETS 123.
http://conventions.coe.int/Treaty/EN/Treaties/PDF/123-Arev.pdf
If you would like to authorize a medical devive the ISO Standard
ISO-110993 will be applicable. and as top of all that it will be necessary to apply for a GLP certificate from your national authority if you would like to circulate your device on the market. It is not too much easy.
Kind regards,
Gabor
The best approach is to start with the Directive (2010/63/EU), then move to your national legislation, which by this time has already transposed the Directive. They shouldn't differ too much.
Once you get a good grasp of the Directive, my advice is for you to go to the European Commission's page on the subject (http://ec.europa.eu/environment/chemicals/lab_animals/home_en.htm) and read the working documents that have been posted there (follow "Legislation and Implementation>>Implementation of Directive 2010/63/EU " on the menu on the left). You'll find everything you need to know, there. It's a lot to take in, so start with the broadest (and the only one that is binding) document first, i.e. the Directive, and then consult the working documents for detailed information on how to put things into practice. If your institution already has a AWB in place and running, they might assist you in whatever you need.
Hi,
I am working in QAU in preclinical CRO, where we conduct non-clinical studies as per different regulatory guidelines, as we are conducting biocompatibilty studies for medical devices as per ISO and USP guidelines, other than these we are conducting toxicology studies as per OECD, FDA, Schedule Y guidelines as we are following GLP principles to conduct studies.
Please find below the some guidelines which we were following for conducting biocompatibilty studies for medical devices
Subcutaneous 13 week implantation test Chronic (26 week) intra muscular implantation test ISO 10993-6 ISO 10993-6
Intrcutaneous reactivity -ISO 10993-10, USP 29 biological reactivity test
Skin sensitization -ISO 10993-10
Systemic toxicity- ISO 10993-11
90-day subchronic toxicity study- ISO 10993-11
Thanks,
Praveen
Hi,
I am working as a veterinarian and lab animal house in charge. Basically GLP in animal experiment varies from country to country. We generally follow CPCSEA guidelinesfor lab animal experiment and housing. Also OECD guideline, Schedule Y, Indian Pharmacopaea, European Pharmacopeia for toxicity studies and other animal experiments.
Thanks,
Ruma
Hi everyone,
Is there any GLP guidelines in this fields?
Many thanks,
Ensari
Holy can of worms, batman. What a question.
I'm just going to point to the source because this would be a book.
If you're in the US, you would follow the US FDA's CFR Title 21 Part 58 regulations: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
If you are outside the US, your country may either follow the aforementioned FDA regulations or a different set issued by your country or other supranational jurisdiction.
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