Quality & regulatory

ABLE Biosciences Quality Management System

Throughout the last year ABLE Biosciences sustained a big effort to arrange its facilities, resources and documentation in order to adequate its internal quality system to GLP regulatory requirements.

In March 2013 the Site received the National Health Authorities inspection; ABLE Biosciences is now waiting for the GLP Certification to be formalized and made effective.

In ABLE Biosciences all the activities are performed following a quality system inspired to GLP.

ABLE Biosciences Good Laboratory Practice

On July 26th, 2013 ABLE Biosciences obtained GLP certification from the Italian Ministry of Health.

GLP certification was granted for Biomarker quantification, Pharmacokinetic, Toxicokinetic and Metabolism studies by means of immunoenzymatic techniques and mass spectrometry.

  • Metabolism and Pharmacokinetics;
  • Quantitative detection and kinetic analysis of drugs and xenobiotics in biological fluids;
  • Quantitative detection of Biomarkers in biological matrices

ABLE Biosciences has its own GLP archive.

Computerized systems and softwares, employed for PK/TK and Biomarkers studies, are validated according to regulatory authorities requirements (US 21CFR Part11, GAMP guidelines).

On April the 4th, 2014, ABLE Biosciences obtained GLP certification for Biotechnology and Molecular Biology Studies.

On March 21st, 2016, ABLE Biosciences obtained the GLP certification renewal within the following areas of expertise:

1) PHYSICAL-CHEMICAL TESTING
9) OTHER (SPECIFY)
9.4) BIOTECHNOLOGY AND MOLECULAR BIOLOGY STUDIES
9.7) PHARMACOKINETICS/TOXICOKINETICS AND ADME STUDIES

ABLE Biosciences Good Clinical Practice

On October the 1st, 2014, following the accreditation procedures in accordance with artt. 1 and 2 of DM 16 Marzo 1998, AIFA included ABLE Biosciences in OsSC register of Private Laboratories qualified to perform analysis on samples derived from drug clinical trials (phase I-II-III)

We encourage clients to audit our facilities.

 

Should you need any additional information, please do not hesitate to contact us: customer@gemforlab.com