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ElMaestro ★★★ Denmark, 2013-05-03 03:26 (4389 d 12:53 ago) Posting: # 10531 Views: 6,405 |
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Hi all, I have been asked to give some input to regulators in the ASEAN region about issues relating to bioanalytical quality standards. One potentially hot potato is Good Laboratory Practice vs. ISO 17025, and I'd like to hear some opinions, pros and cons for these standards. GLP can be further subdivided into OECD, EPA and 21CFR58, but I think we can disregard EPA and 21CFR58 here. My own present opinion: From a science perspective I think the ISO standard is a bit more relevant to BE bioanalysis than GLP. The clauses of ISO are by nature more concretely relating to bioanalysis and hence easier to relate to for lab personnel, QC people and even evil and ugly auditors like myself. The scope of the OECD GLP guidance is worded borderline problematically, and hence many aspects rely on heavy interpretation of some general clauses. I have not come across any GLP observation that could not be translated into a corresponding ISO17025 observation. Thus I believe that ISO 17025 has some scientific advantages over GLP. On the other hand bodies like EU/EMA and WHO enforce GLP explicitly for BE; GLP has existed longer than ISO 17025 and hence I might be inclined to think that bodies that enforce GLP do so for historical reasons rather than for scientific merits. I would very much welcome some opinions both from those who favor GLP and from those who favour ISO 17025. And if you happen to know some other standard which has some potential advantages over GLP and ISO then by all means educate me, please. Thanks for any input in advance. — Pass or fail! ElMaestro |
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Helmut ★★★   Vienna, Austria, 2013-05-03 16:15 (4389 d 00:05 ago) @ ElMaestro Posting: # 10534 Views: 5,246 |
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Hi ElMaestro! ❝ I would very much welcome some opinions both from those who favor GLP and from those who favour ISO 17025. Just my experience with the predecessor EN 45001: In the CRO I worked for we discussed the pros & cons in the late 1980s. We considered EN 45001 too inflexible because you have to get an accreditation for every new analytical method (and modifications of ‘old’ ones as well). Leaving the monetary aspects aside contrary to GLP it is a time consuming procedure (filling the application with an accreditation body, wait for the assessment,  ).No qualified opinion about ISO 17025 (duno any accredited lab). P.S.: We got our first GLP-certification in 1992… — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Ohlbe ★★★ France, 2013-05-11 18:27 (4380 d 21:53 ago) @ ElMaestro Posting: # 10572 Views: 5,226 |
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Dear ElMaestro, First of all I am not familiar with ISO 17025, so I will not have an educated opinion on its merits. ❝ On the other hand bodies like EU/EMA and WHO enforce GLP explicitly for BE; GLP has existed longer than ISO 17025 and hence I might be inclined to think that bodies that enforce GLP do so for historical reasons rather than for scientific merits. That's what I understood from a discussion with an EU regulator some years ago, when the previous version of the EU BE guideline was published and first asked for GLP compliance. At that time a large proportion of the BE trials submitted in Europe were still performed there. The CROs doing the bioanalytical work were also often involved in bioanalysis for preclinical safety studies, for which they had to follow GLP (no choice there, it was fully in the scope of GLP). A number of them also claimed GLP compliance for their BE trials. It made sense to ask the CROs to follow GLP for BE trials too, rather than recommend ISO, which would have resulted in a double reference system, and in a sudden raise in the suicide rate amongst QA staff. Nowadays most trials submitted in the EU come from India and Canada, and few of these labs are involved in activities formally falling in the scope of OECD GLP (preclinical safety studies). It could make sense to give them a choice between GLP and ISO 17025, if this ISO norm is really suitable. I would say that one thing to keep in mind is that ISO is primarily a voluntary thing, while GLP compliance can be mandatory depending on the activities. — Regards Ohlbe |
Ing. Helmut Schütz