Want to know more about our services? Call, mail, or send us a message.
The Principles of Good Laboratory Practices (GLP) are a managerial quality control system, covering organizational processes and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and retained (or archived).
A lot of actors (study sponsors, management, study directors, quality assurance personnel, archivists, study personnel, and IT) are involved in the development, implementation and follow-up of the GLP quality system.
Therefore, correct understanding and interpretation of the content of the principles of GLP are crucial to produce high quality and reliable data.
Implementing a Good Laboratory Practice (GLP) system is a laborious and multidisciplinary effort. Looking from an inspector’s point of view, we can assist companies with the planning and installation of a GLP-compliant Quality Assurance (QA) system, the review and optimization of existing quality systems and the conduct of mock-inspections:
Training future GLP personnel prior to GLP implementation is highly recommended to obtain a basic understanding of GLP and to increase the efficiency of implementation.
Performance of a gap analysis of an existing quality system to identify areas of deficiency. Followed by the development of an implementation plan with management staff to bridge these gaps.
Support to write, review and/or adapt quality documents such as standard operating procedures (SOPs) to ensure that appropriate procedures are in place as defined by the GLP regulations. Since all laboratories function differently, these SOPs are laboratory-specific.
Other documents for review can include: computerized system validation (CSV) dossiers, method validations, ….
Support in planning as well as the conduct of inspections on simulated studies (‘mock studies’).
Before or after the selection of a Contract Research Organization (CRO) or during study performance, on-site inspections on behalf of study sponsors can be considered. Services include: inspection of the GLP compliance status by conducting facility audits, in-process study audits, or by evaluation of internal procedures.
In-house quality assurance (QA) support at CRO locations with GLP accreditation challenged with workload. This include performing GLP study audits (study plan/amendment verifications, critical phase inspections, raw data verification, final report review, …) as well as facility or process audits.
Copyright © 2024 | Agirad