Both, Cap't'n ! [GxP / QC / QA]

posted by ElMaestro  – Belgium?, 2019-01-21 09:42 (617 d 09:15 ago) – Posting: # 19791
Views: 3,703

Hi Ohlbe,

thanks for the insight.

» This requirement for GLP compliance triggered some rather strong reactions. Strangely enough, not really from industry (after all, most CROs were already claiming GLP compliance in their reports), but from some regulators. The MHRA was particularly pissed off, and eventually their GLP inspectors issued a clarification statement, according to which there was no need for labs analysing BE samples to be part of a GLP monitoring programme. The MHRA shared nobody's opinion that GLP is strictly and only applicable to preclinical safety studies, and actually threatened to prosecute any UK lab that might claim GLP compliance for other activities. Some other regulators shared ElMaestro's opinion: GLP is mandatory for preclinical safety studies, but it's written nowhere that you can't claim GLP compliance for anything else. Actually I've heard that some EU monitoring authorities (Spain and a few others) did perform GLP inspections and issued GLP compliance statements for labs analysing BE samples, but no preclinical samples. So much for EU harmonisation.

Is there anything in the public domain about the threat to prosecute? Does it mean in the UK you cannot write in a MV for BE or in a BE SR that you comply with GLP?

Also,I think that when regulators can disagree so much in the meaning and interpretation of guidance then there is a clear and present need for a radical update -at least a major revision- of the documents. No wonder, in light of this, that some companies are very uncertain as to what they need to do in order to comply EU-wide with guidelines. I had no idea this was so controversial; I only saw it as a big confusion.
Thanks again.

I could be wrong, but...

Best regards,

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

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