QUALITY
GLP
Vetspin is certified for the Good Laboratory Practice since 2006.
The studies performed under GLP are:
- Residue studies
- Pharmacokinetics/Toxicocinetic/ADME studies (also bioavailability and bioequivalence studies)
- Tolerability studies
- Physical-chemical testing
The Quality Assurance guarantees the maintenance of a quality program, consisting of study-, facility- and process-based audit which ensures the internal control of the GLP requirements; moreover a system of procedures allows managing all the critical and salient points for the performance of the studies and the management of the processes at the facility. The Quality Assurance has also the tasks of preparing the test facility to the biennial GLP regulatory authority inspection and of training personnel for GLP.
Vetspin is registered at Italian Ministry of Health as CRO for Good Clinical Practice since 2013.
GCP
The studies performed under GCP are:
- Clinical trial
- Dose confirmation studies
- Efficacy studies
There is a system of procedures to organize the various stages of the study and the processes of the facility. The Quality Assurance Unit performs audits to the study, both on documents and on the experimental phases. Quality control of data is part of the quality assurance and has the duty to verify the correctness of the data processing and the input of the data in the study.
GCP
The studies performed under GCP are:
- Clinical trial
- Dose confirmation studies
- Efficacy studies
There is a system of procedures to organize the various stages of the study and the processes of the facility. The Quality Assurance Unit performs audits to the study, both on documents and on the experimental phases. Quality control of data is part of the quality assurance and has the duty to verify the correctness of the data processing and the input of the data in the study.
