What do we need to do to be certified as a GLP laboratory?

B

BusyBee

#1
Dear colleagues,

How does a lab apply for GLP certification or establish a record of compliance?
I work for a small life sciences company with main focus on R&D, non-clinical efficacy and safety test studies of medical devices. The goal is to establish GLP compliant test facility (for internal use).
We already have started stepwise implementation of GLP requirements recommended in handbook for non-clinical R&D which makes a lot of practical sense even for "in house" record keeping.
What are the steps to gain official status?

Thank you,
Albina
 
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Stijloor

Staff member
Super Moderator
#2
Re: What do we need to do to be certified as a GLP lab?

Hi Albina!

It's weekend and fairly quiet here at the Forums. But come Monday, I am sure that you will get a response.

Stijloor, Moderator.
 

Ajit Basrur

Staff member
Admin
#4
Re: What do we need to do to be certified as a GLP lab?

Dear colleagues,

How does a lab apply for GLP certification or establish a record of compliance?
I work for a small life sciences company with main focus on R&D, non-clinical efficacy and safety test studies of medical devices. The goal is to establish GLP compliant test facility (for internal use).
We already have started stepwise implementation of GLP requirements recommended in handbook for non-clinical R&D which makes a lot of practical sense even for "in house" record keeping.
What are the steps to gain official status?

Thank you,
Albina
Hi Albina,

Since you are in the FDA regulated industry, did you have a look at 21 CFR Part 58 - Good Laboratory Practice for Non clinical Laboratory Studies ?
 
B

BusyBee

#6
Re: What do we need to do to be certified as a GLP lab?

First of all I would like to thank everyone for the provided info: it got me onto the right start.
For the sake of argument, let’s say we have done gap analysis, have a QA Unit and study director in place, SOPs written, personnel trained to conduct the study.
Unfortunately, I am still not clear on the proper procedure for new testing facility in terms of requesting inspection and obtaining GLP certificate prior to claiming GLP compliance.

I have found a guidance document provided by Canada Monitoring Authority with requirements for the recognition of GLP compliant facilities. Does analogous document exist for US?
Thanks,
Albina
 

Attachments

D

DaveDavis

#7
I don't believe there is a body which accredits you to GLP compliance... it's just a claim... like self-certification to CE. The next step would be CLIA certification or applying for laboratory state license -- although these are more for true clinical labs. Your claim to GLP compliance will be reviewed (and audited) by you customers.

You can also engage in proficiency testing by CAP or other certified bodies.
 
B

BusyBee

#9
Hi
I would be very grateful for the checklist indeed.
I think my novice confusion comes between
two main guidelines applicable: GLP for non-clinical studies and ISO/IEC 17025. Let me see if I get it right: GLP regulates the condition under which the study is conducted to assure the quality and integrity of data collected. ISO/IEC 17025 is the main standard used by testing and calibration laboratories and maintains criteria the laboratory must meet to demonstrate the qualification to generate data in the first place. Testing facility should be accredited before claiming compliance with ISO 17025 but could claim that study is GLP complaint without being audited as long as Study Director approves protocol. Did I miss something?
I understand how this concept works for third party testing lab but if my lab conducts testing for internal use only (internal SD, QA unit) who could be the first to give a nod for "this study is in compliance"?


Albina
PS attached paper is quite useful for the beginners like myself

 

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