'Good Clinical Laboratory Practice (GCLP) is intended to provide guidance on the quality system that can be applied internationally by organisations and individuals that undertake analyses of samples from clinical trials. This includes guidance on the facilities, systems and procedures that should be present to assure patient safety as well as the reliability, quality and integrity of the work and results generated during their contribution to a clinical trial.' - RQA GCLP
Global Pharma QA will assist your GCLP Laboratory to meet these standards.
We provide GCLP Compliance Certificate that can be extended every 2 year.
The Certification process includes:
-
For a first Certification, we recommend a Gap Analysis to recognize the gaps from GCLP Compliance, provide observations and advice of possible ways to close the gaps.
-
GCLP staff Training (ending with a quiz and a Training Certification)
-
When ready, conduct a 2-days full GCLP Audit followed by a report detailing the observation noted, and finalising the inspection after reviewing the CAPAs by providing a GCLP Compliance Certificate (valid for 2 years and can be extended after a reinspection)
Copyright © Orit Galperin. All rights reserved.