The quality requires to be costantly on allert
The quality in clinical trials is a moving target and Good Practices (GXP) face the continuous development of ethical and scientific standards. It is crucial to maintain a level of high proficiency even when you consider services from external providers.
The Sopharma` Pharmakokinetic Unit operates under GLP/GCP principles and is constantly involved in the assessment of the quality of bioanalytical data.
To ensure proven competence and to confirm the high standards of quality are met, the Pharmacokinetics team has taken a decision for annuall participation in Proficiency testing schemes. The hardest challenge for us was that most of the participants in this attestation scheme are equipped with the top class of analytical instruments. However, we`ve systematically reported results with accuracy in narrow range around assigned value (mean z- score achieved is ± 0.4, as the ideal score is 0, with satisfactory range of z-score ± 2) and in most of the cases even surpassing the estimates, reported by analytical laboratories with state of the art equipment.
This achievement serves not only as an international recognition for a high quality analytical work but also gives an opportunity to assess and continuously improve the level of proficiency of the team.