European Union (EU)

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Most recent GLP documents:

EU GLP webpage 

This is the website of the European Commission GLP working party – basically a GLP working party made up of European Union member GLP monitoring authorities who discuss GLP interpretation and organisation within the EU with the aim to standardise interpretations across the EU.  Generally it’s the same representatives as attend the OECD GLP working parties. Therefore I would expect information and decisions to be very similar to the OECD view point but  I still think it’s a valuable source of information. 

*New* FAQ A series of GLP interpretation questions – a good source of information on inspector thinking and interpretation – might be useful if you get asked a similar question and are looking for guidance

Guidance for GLP facilities on the implementation and maintenance of a risk-based quality assurance programme. This is the MHRA Risk based QA Programme paper that has now been adopted across the EU,  meaning that it is acceptable for all EU GLP facilities to operate a risk based QA Programme meaning the frequency of audits can be determined by risk, rather than once every three months or every study

2004/9/EC – Inspection and verification of GLP (recodified)

2004/10/EC – Harmonisation of laws, regulations and administrative provisions relating to the application of GLP (re-codified)

Cross-contamination of control samples with test item in animal studies (November 2004)
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