pharm-analyt has been GLP (Good Laboratory Practice) certified since 1992, as test lab for preclinical and clinical* studies, and GMP (Good Manufacturing Practice) certified since 2006 (as control lab).
Being GLP certified for over two decades clearly has left its imprint on every area of the company: Starting with sample arrival and storage, to study planning, sample preparation, actual analysis, reporting and archiving. Every step is done according to standard, and all of our infrastructure is built to it.
Of course there´s a lot of effort involved, but the returns are low error rates and high traceability, reproducibility and higher predictability.
The cost of quality might be high, but it clearly pays off.
* within the scope of the “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples” (EMA/INS/GCP/532137/2010)