Quality & regulatory

GEM FORLAB s.r.l. includes ABLE Biosciences-GEM FORLAB s.r.l. , a GLP certified Test Facility also included by AIFA (Agenzia Italiana del Farmaco/ Italian Medicines Agency) in the OsSC register of Private Laboratories qualified to perform analysis on samples from clinical trials (phase I-II-III).

We encourage our clients to audit our facilities.

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

Good Laboratory Practice Certification

On December 19th, 2018, ABLE Biosciences – GEM FORLAB s.r.l. obtained the GLP certification renewal within the following areas of expertise:

Validation of analytical methods in compliance with national and international guidelines

1) Physical-chemical testing;
6) Residue studies;
9) Other(specify):
9.4) Biotechnology and molecular biology studies;
9.7) Pharmacokinetics/toxicokinetics and ADME studies.

ABLE Biosciences-GEM FORLAB s.r.l. has its own GLP archive.

All computerized systems and software are internally validated according to regulatory authorities requirements (US 21CFR Part11, GAMP guidelines).

Clinical Practice

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

Quality Management System

All activities in GEM FORLAB which are not otherwise regulated, are performed following an internal quality system inspired to GLP principles.

Clinical diagnostic authorization

GEM FORLAB has recently received the authorization for clinical diagnostics as private laboratory from the regional authorities in Piemont (DD 1328/A1414C/2020).

GEM FORLAB is authorized to perform diagnostic assessments at high technological and professional level in the field of Microbiology and Serum immunology.

In 2021 GEM FORLAB obtained the accreditation of the molecular method for the detection of Sars-CoV-2 in oropharyngeal swabs by the Department of Microbiology and Virology of the AOU Città della salute e della scienza di Torino which acts as regional reference laboratory.