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Test validity for the regulatory bodies
You asked if your laboratory's use of a internal Standard test method will be valid for the regulatory bodies, even if you are not accredited.
I am not in the position to comment on specific regulations (e.g. FDA GMP) and can only comment from an ISO 17025 implementation and accreditation point of view. Performing a test is only a part of the overall management system requirements of ISO17025. The competency required to provide a consistently valid result is demonstrated through a number activities to meet the requirements of ISO 17025. Hence the importance of accreditation – the process of independent assessment and attestation to this competency.
I do not know what regulatory bodies you are referring to, nor the purpose of the test, i.e. type of product and application. Bear in mind the requirements may be different; for example if the test results were being used for quality control for a manufacturer, compared to studies for research or a product registration. As the laboratory, your responsibility is to understand, define and document the requirements for the work you do. Out of interest, I can mention that if the testing relates to alcohol-based hand sanitizer products during the COVID-19 pandemic; the FDA has issued a Temporary Policy for the preparation of certain products. See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during
I suggest you enquire as to the specific requirements of your customers (the use / purpose of the test result) and the requirements of their applicable regulatory bodies. ISO 17025:2017 clause 7.1 Review of requests, tenders and contracts and clause 7.2 Selection Verification and validation of methods are particularly relevant to your question. These are covered under section 09_Customer_Service and 10_Test_and_Calibration_Method in the ISO 17025 toolkit. https://advisera.com/17025academy/iso-17025-documentation-toolkit/
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ISO17025 Stage 1 Application- Covid Testing
Tested began as a Research project looking at the detection of SARS-CoV-2 in *** via qPCR using a hypecube pooling method. We would like to become an accredited facility offering Covid-Testing to the University. However our method is not CE Marked and potentially need to apply for derogation. Is this something you have encountered before and can provide advise on how to go about this. Secondly any advise on what is required for Stage 1 Declaration Application. -
Question about clause 4 of ISO17025:2017
I want to ask a question about the impartiality clause in the ISO17025:2017 standard. I understand all the requirements about the impartiality, but as an auditor of the laboratory i want to ask you, How should i audit this clause of the standard? Which document or information should i be looking for to make a decision if the laboratory is compliant to this clause. The same goes with confidentiality. -
What is EQA Test in ISO17025
Our lab is a petrol and diesel lab, and our lab says we need to do an EQA Test to get iso 17025. I did not understand the EQA Test.
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GMP license
... 17025 certified versus having a drug establishment license from Health Canada and letter of Compliance from the FDA. àA third part lab we use does not have ISO 17025 àbut does have the other 2 items mentioned, they are an approved lab for Pharmaceutical testing and we manufacture for both Pharmaceutical companies and Dietary companies. àIs there anything outside the requirements for a GMP license by Health Canada that ISO 17025 has that would impact the validity of the test results from a lab that doesnâÂÂt have ISO 17025. àIt is also not a requirement to have ISO 17025 but there can be an equivalent license. àWould the Health Canada license be considered equivalent?
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GMP accreditation
I have been asked to help a company with ISO 22716:2007 GMP accreditation.
Unfortunately, my experience is within the Pharmaceutical industry only working with the TGA, APVMA, and ACO for 25 years + so I have no knowledge of what is required to be ISO accredited.
I visited the company yesterday and it would be starting from scratch as they just make all-natural, non-toxic, vegan skin care products which are filled, packed, and sent straight out to online customers only.
There is no testing of raw materials, packaging, or finished product.....
They have no documentation at all established and I was wondering if they need to be ISO 9001 Quality Management as well as being accredited for ISO 22716 GMP compliant for Cosmetics?The company is looking to expand into the USA market.
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Setting up a Microbiology Lab and getting cannabis GMP certification
Is it possible to get GMP certification on cannabis testing within a laboratory without having GMP certification in the Microbiology dept.
If not, then if the laboratory is ISO 17025 accredited, then presumably we will have to get GMP accreditation first for the Microlab and then for cannabis testing, or can we combine the two?
Can you give a brief overview of what we need to do to achieve this?
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Detailed chain of custody from a lab accredited ISO17025
I have had a lab test done to determine a chemical substance quantity at a lab certified ISO17025. The sample went to further labs. The certified 17025 lab refuses to provide a chain of custody with full records and photographs stating they are notobliged to -
Applicability of 17025 to GMP analytical laboratory
The question is about the applicability of 17025 to our operations. We are a GMP analytical laboratory that conducts lot release testing for pharmaceutical and/or biological products used in clinical trials and eventually for commercial. We abide by 21CFR11.
We only test these medicines. We do not manufacture.
Does ISO 17025 apply to our operations?