ISO 17025 - GLP (Good Laboratory Practices) Gap Analysis

Does anyone have a GAP analysis for GLP-ISO 17025? The lab I am in is currently 17025 and has been for 10+ years but we are looking into becoming GLP complient as well. I have worked on a gap analysis but every time I come to a gap I sidetrack and go work on the gap. I'm driving myself crazy trying to finish this. Has anyone been through the same and have an analysis done that they would share?

Thanks in advance!

Re: ISO 17025 - GLP Gap analysis

Any comments or help with this one anyone? My Thanks in advance!

Re: ISO 17025 - GLP Gap analysis

cote75 said:

Does anyone have a GAP analysis for GLP-ISO 17025? The lab I am in is currently 17025 and has been for 10+ years but we are looking into becoming GLP complient as well. I have worked on a gap analysis but every time I come to a gap I sidetrack and go work on the gap. I'm driving myself crazy trying to finish this. Has anyone been through the same and have an analysis done that they would share?

Thanks in advance!

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Welcome to the Cove

As per Department of Standards Malaysia,

GLP is about recognition of a quality system that has organisational processes and conditions that in accordance with OECD criteria. ISO/IEC 17025 accreditation is a formal recognition for technical competence to undertake specific tests or calibrations. In general GLP is used for non-clinical health & safety studies that are often called for in regulations while ISO/IEC 17025 accreditation is used normally voluntary. Laboratory accreditation to ISO/IEC 17025 is for routine testing and measurement while GLP is anon-routine work covers under the non-clinical safety studies. Examples of non-routine work may include dosing animals or spraying fields. Only OECD GLP compliance can provide an effective quality system that gives regulators the necessary confidence in relation to how non-clinical health and safety studies are planned, performed, monitored, recorded, reported and archived.

Additional material here - http://www.apat.gov.it/site/_files/Doc_Iupac/S1_03_IS_Caroli.pdf

Re: ISO 17025 - GLP Gap analysis

Thanks for welcoming me!

I really like the pdf, thank you. Caroli was at a GLP meeting I went to in San Jose last November.

I have been to several GLP meetings and I have the ISO 17025 accreditation so I understand the differences pretty well. What I'm trying to figure out is a check list type 'cheat sheet' so I am not missing any SOPs before we start accepting GLP work. This is a big help though, thanks again

Re: ISO 17025 - GLP Gap analysis

Hi,
I am working on the same project. We are currently ISO 17025 and also do GMP work. We are working on GLP for a specific department. So far I have identified that I will need SOPs for the following:

Roll of Study Director
Roll of QA Unit
Roll of Study Personnel
Sponsor Contacts
Responsibility of Test Facility Management
Protocols and Amendments
Deviations
Master Schedule
Submission of Samples and Control Articles
Receipt
Handling and Storage
GLP Audits
Archiving

I, too am struggling with the gap analysis, so take a look at my list and tell me if you have identified any other requirements.

Thanks

Re: ISO 17025 - GLP Gap analysis

Great list. Thanks! I will compare it to what I am working on and we can go over it more. I'm glad to find someone else working on the same thing

Re: ISO 17025 - GLP Gap analysis

Hi gang!
I've attached one here from NATA (Australian version of NIST), which is the only one I've ever been able to locate, after many, many searches. If you dismiss the references to NATA and NAR in the text, the direction it gives is to the point and effective. I've used it as a guideline for four facilities now, and it has proven to be a very good tool.
17025 is a peculiar beast, especially when the lab is part of a larger organization that already has a Quality Department and a Quality Manager or Director. Fur can start flying over 'territorial jurisdiction' relative to who should have surveillance over lab processes. We've divided up the internal audits, leaving the process audits up to the lab QM, and the overal standards audit to qualified internal auditors from the main Quality Department. Seems to be working o.k.
Good luck with your accreditation. Hope all goes well for you.
~Spanky~

Hi there,

We are a european CRO (precinical trials), we would like to get the FDA GLP certification. Anybody Know how to get it?

On the other, it would be acepted by FDA authorities a drug study that it had been realized at european facility certified by european agencies im compliance with GLP?

Thank you very much in advance.