'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:
1. For first Certification we recommend a preliminary Gap Analysis to recognize the gaps from GCLP
Compliance, provide observations and advice of possible ways to close the gaps.
2. GCLP Certified staff Training (ending with a quiz)
3. When ready, 2 days full GCLP Inspection followed by an inspection report detailing observation noted and
finalising the inspection by a GCLP Compliance Certificate (valid for 2 years)
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