Good Laboratory Practice Certification
On September 9th, 2022, 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;
9.4) 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 requirements (US 21CFR Part11, GAMP guidelines).
On October 1st, 2014, following the accreditation procedures in accordance with art. 1 and 2 of DM 19 Marzo 1998, AIFA included ABLE Biosciences in the OsSC register of Private Laboratories qualified to perform analyses in 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.