Talk:Good laboratory practice

GLP in New Zealand and Denmark 1972?

Never heard of this and there is no proof provided. I would suggest to delete! WertPacket (talk) —Preceding undated comment added 11:22, 3 April 2013 (UTC)

The lede summarizes what is in the body of the article. The body of the article begins with "History" and the very first sentence concerns the point you raise, and a source is provided there. Sources are only needed in the lede if content from the body is summarized or generalized in such a way that it goes beyond what is in the body. That is not the case here -- it is a simple historical fact. Jytdog (talk) 11:55, 3 April 2013 (UTC)

Does GLP stand for Good Laboratory "Practice" or Good Laboratory "Product" ???

dsg vtch ndr 7ut6gj vzuuin tzu jktzj zjzt zj mukluiol vuzt ukl — Preceding unsigned comment added by 77.238.215.171 (talk) 13:31, 21 February 2012 (UTC)

Can the following question be answered:

Can a laboratory product, such as a measurement device, data acquisition hardware / software, data analysis software, can such a product be labeled as GLP by the manufacturer?

Is there a GLP acreditation organization for laboratory products and software?

It's my understanding that a piece of software or hardware can have features that facilitate "Good Laboratory Practice" but that asking if software or hardware is "GLP" or "GLP validated" is asking an incorrect question, because each end-user or lab must prove to themselves that the software or hardware operates according to specification as part of their performance of GLP.

Is this correct?

Does asking the question -> "Is your hardware / software product GLP validated" indicate a lack of understanding of what GLP is or how to carry out GLP? —Preceding unsigned comment added by 69.159.219.48 (talk) 14:49, 26 August 2008 (UTC)

This really needs to be redone. Shouldn't we get a list up here of what following the GLPs entails, specifically, like "personnel training logs must be archived..."? The fact that the FDA regulates "industry" - the pharmaceutical industry, etc., and the GLPs are their guidelines that contract labs must adhere to, etc etc... —Preceding unsigned comment added by 68.63.169.154 (talk) 02:43, 8 November 2008 (UTC)

Move

The following discussion is an archived discussion of a requested move. Please do not modify it. Subsequent comments should be made in a new section on the talk page. No further edits should be made to this section.

The result of the move request was: move Graeme Bartlett (talk) 06:44, 16 January 2010 (UTC)

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{{movereq|Good Laboratory Practice}}

Good laboratory practice → Good Laboratory Practice — "Good Laboratory Practice" is a proper name and should be capitalised as such, it is not a subjective "principle", but a set of specific guidelines to be adhered to. Inflatable dartboard (talk) 20:47, 8 January 2010 (UTC)

• Oppose no need for capitalization. It is a term not a proper name. --Labattblueboy (talk) 23:25, 8 January 2010 (UTC)
• Support: it looks like that is the correct way of writing it. --TakenakaN (talk) 01:04, 9 January 2010 (UTC)

The website you cite has it clearly written as a principle not a proper name.--Labattblueboy (talk) 21:19, 9 January 2010 (UTC)

No, if you care to read it, it's properly capitalised by the OECD on their website. Inflatable dartboard (talk) 22:47, 9 January 2010 (UTC)

I might agree if the article was OECD Principles of Good Laboratory Practice, but its not. Its the general concept of good laboratory practices worldwide. --Labattblueboy (talk) 23:09, 9 January 2010 (UTC)

No it's not. Try reading the article. It is a specific set of named guidelines, hence the proper name. If we follow your absurd logic, surely Organisation for Economic Co-operation and Development should also be decapitalised and rewritten to waffle on generally about organisations that generally support economic co-operation and economic development? Inflatable dartboard (talk) 23:47, 9 January 2010 (UTC)

The articles covers guidelines as specified by the OECD, FDA and EU, which are not all necessarily the same in all capacities. If all good laboratory practices were all the same then I would be inclined to support capitalization. However, the article currently describes a class of entities not a single entity, which is an essential factor in differentiating a proper noun from a common one. Furthermore, a number of the EU directives doesn't capitalize the term, nor does the WHO handbook.--Labattblueboy (talk) 01:44, 10 January 2010 (UTC)

Please explain how you can rewrite English grammar so that proper nouns are not capitalised. The OECD always capitalises it, as should Wikipedia. Inflatable dartboard (talk) 19:42, 10 January 2010 (UTC)

• Support. The article does appear to be about a proper noun, a standard set by the OECD. That does not excuse Inflatable dartboard to be as incivil as he is above. Ucucha 13:11, 12 January 2010 (UTC)

I have to disagree that the article is only referring to the OECD. the articles contains sections; 'GLP and the OECD', 'GLP and the FDA', 'GLP and the European Union' and 'GLP and non-OECD' member-countries. Those bodies outside of the OECD do not necessarily capitalize the term. If the article contained only the OECD principles, I would agree that capitalization would be very appropriate because it would then refer to a single entity and thus be proper, but that is currently not the case.--Labattblueboy (talk) 20:47, 15 January 2010 (UTC)

My impression was that GLP, while created by the OECD, was also used by the EU etcetera in a similar form. Ucucha 20:48, 15 January 2010 (UTC)

The above discussion is preserved as an archive of a requested move. Please do not modify it. Subsequent comments should be made in a new section on this talk page. No further edits should be made to this section.

Total and complete disagreement with some sections of this article

As both an an ex-academic in the biologic sciences and with industry experience but with zero stake in the issues here I have to comment because of unacceptable bias. The section "Criticism of GLP" section completely misses the point and shows unacceptable bias for academic research: An experiment can be scientifically silly from some perspectives but still GLP-acceptable. The scientific robustness is really a separate matter. The first two paragraphs here are fine, but the third one beginning "nonetheless,..." is blatently biased to academic research. A few points: Academic studies, for all intents and purposes, are never subject to an audit process. Commercial studies are routinely subject to internal audits (every single one of them as oer GLP), sponsor audits if the work is outsourced and much GLP is outsourced (again, all studies unless you are a negligent sponsor), or government audits (any study can be audited, few are, generally only pivotal studies). As a consequence of the complete absence of any audit trail of any sort, the claim that "Thus financially-independent data tends [should be "tend", not "tends"] to be the most reliable knowledge mankind has" cannot be supported by any reasonable and experienced person in the field.

And the subsequent example is largelyimmaterial to the real notions underlying GLP. I am not familiar with the issue but that to me seems more about scientific debate than GLP itself. This section is misleading to the point of being dangerous to the uninformed. Yes, there is a bias to sponsor-driven research and GLP is one means to counter that bias. But to claim that academia is free is bias is, well, a biased opinion in of itself. ---- — Preceding unsigned comment added by NoDarnGood (talk • contribs) 16:25, 28 August 2011 (UTC)

As an engineer who leans more toward the pure science part of the profession, it's worth stating the obvious: The peer review system *IS* the audit process of academic studies. Commercial research can't use that process because much of the information they work with is proprietary. So an audit structure must be set up. This whole article sucks. It was copy-pasted from some whitepaper or other distributed at some get-together of commercial scientists lab workers (not to impugn them, I impugn the article), and has very little relevance to the academic side of science. Johnny Wishbone (talk) 21:35, 19 November 2011 (UTC)

Agree that the article is not worth the time spent reading it. However, peer review for academic studies does not even come close to the rigor of a GLP audit in industry. — Preceding unsigned comment added by 150.148.0.65 (talk) 18:37, 12 April 2012 (UTC)

I totally agree with previeuw remark: The section "Criticism of GLP" section completely misses the point and shows unacceptable bias for academic research: An experiment can be scientifically silly from some perspectives but still GLP-acceptable. The scientific robustness is really a separate matter. The first two paragraphs here are fine, but the third one beginning "nonetheless,..." is blatently biased to academic research. — Preceding unsigned comment added by Gaja 55 (talk • contribs) 21:56, 18 December 2011 (UTC)

setion about Klimish score

In my opinion Klimish scoring and use of GLP principles for OECD test guidelines is a total other discussion. Most authors make the mistake to link GLP principles with OECD test guidelines.

The OECD GLP principles and the OECD test guidelines are 2 different guidelines of the OECD and you should not mix/link them in a dictionary. This creates confusion.

Klimish scoring is not relevant for this page.

--Gaja 55 (talk) 09:58, 6 July 2012 (UTC)

section about criticism on GLP

As far as I can read, I don't find back any criticism on GLP principles itself in this section.

What I read is a criticism about "the preference of the regulatory authorities to use GLP principles as their favorite quality system to verify the studies done according to OECD test guideline protocols". That is a totally other discussion and should not be discussed of this page. --Gaja 55 (talk) 10:09, 6 July 2012 (UTC)

The definitions of "uniformity, consistency, reliability, reproducibility, quality, and integrity"

These words are written in the article but they obviously have more specific meanings in GLP. Somebody please write some definitions/examples for each of these: "uniformity, consistency, reliability, reproducibility, quality, and integrity". --Waqqashanafi (talk) 11:45, 23 May 2016 (UTC)

New Zealand/Denmark 1972

Still, after 3 years, with any evidence, there is still the fantasy-like introduction wie GLp in New Zealand and Denmark. Does nobody feel responsible to change that? — Preceding unsigned comment added by 79.230.191.61 (talk) 20:52, 27 July 2016 (UTC)

It is mentioned in the book: Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA Professional, Edited by PA Carson and N Dent (p. 175) 85.129.0.68 (talk) 12:41, 28 July 2022 (UTC)

unsourced section

moved the following here per WP:PRESERVE. Per WP:BURDEN, do not restore until reliable sources are found and this content is checked against them:

Criticism

GLP regulations require adequately qualified personnel, adequate facilities, a single qualified study director for each study, a quality assurance unit, adequate test system care facilities, characterized test articles/test items, equipment that has been proven to perform as required and is adequately inspected, cleaned and maintained, standard operating procedures approved by management (not QA), proper documented care of test systems, a study protocol/plan with specified content approved by the study director, and a study report with specified content. The GLP regulations require documentation of any laboratory worksheets, records, memoranda, notes or exact copies thereof, that are the result of original observations and activities of a non-clinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study and an archive for orderly storage and expedient retrieval of all raw data, documentation, protocols/plans, and specimens generated as the result of a non-clinical laboratory study.

Although it is good scientific practice to assure equipment is functioning properly, people are qualified, data are recorded properly, etc... Even though hundreds of facilities around the world, including developing countries, have demonstrated the capability to successfully perform GLP compliant studies, others continue to argue these good scientific practices are too difficult for them to satisfy. Some researchers make the argument that since studies that do not meet these quality standards may be published in peer reviewed scientific journals, good science may be performed without GLP compliance. It is accurate to state that compliance with GLP regulations does not assure good science.

-- Jytdog (talk) 18:24, 14 February 2017 (UTC)