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Clinical and Medical Laboratories

Good Clinical and Laboratory Practices (GCLP)

GCLP Audit encompass all aspects of clinical trial laboratory operations: organization and personnel, facilities, equipment, materials and reagents, standard operating procedures, planning of the work, sub-contracting, trial materials, conduct of work, reporting results, quality control & quality audits, archiving, and confidentiality

GCLP Audit provides a bridge between GCP and GLP in clinical trials. It is also a framework in which organisations can base to develop facilities, systems and procedures that guarantee the laboratory work and results fulfill the GLP and GCP expectations

Our GCLP Audit strategy applicable across the clinical laboratories up to three tier public health system, Diagnostic Labs, Research Labs, Clinical Trial related Central Clinical laboratories.

In India, GCLP third party audit schemes is a pre-requisite for clinical laboratories applying for NABL accreditation, we as a third party audit agency we ensure the compliance across all areas

GCLP Audit applies those principles established under GLP for data generation used in regulatory submissions relevant to the analysis of samples from a clinical trial. At the same time it ensures that the objectives of the GCP principles are carried out. This ensures the reliability and integrity of data generated by analytical laboratories

GCLP Audit will create uniformity and standardization of systems within the organisation to assure the highest quality. We conduct the GCLP Audit in line with the ICMR GCLP practices, NABL in accordance with ISO/IEC-15189:2007