360CQA provides audit services for clinical and bioanalytical laboratories. Service includes human samples for efficacy and safety parameters, biomarkers, Gene testing, and other specialty analysis, bioequivalence, etc.
Our highly experienced, trained, and competent team of GCLP auditors has conducted more than 100 audits according to international and China regulations, involved in more than 50 laboratories located in China.
Scope of the GCLP Audit includes:
Tour the facilities
Evaluate the facility for the construction and size suitability
Evaluate the flow of the working practices applicable to the facility
Interview the Laboratory Management and other key staff regarding their role and responsibilities (Organization and Personnel).
Evaluation of sites level of compliance with the study protocol requirements, SOP, and adherence to applicable regulations and GCLP guidelines
Review of the Quality Assurance program
Evaluation of documentation practices
Review of a representative sample of the laboratory data
Need to define the data sampling plan for the audit
[Example: % of data to review]
Review assay acceptance and repeat the process
Review reagent preparation and qualification
Review of the assay method validation
Review receipt, storage, and retention of clinical samples
Evaluation of suppliers or vendor qualification
Evaluation of record storage conditions, retention, and archive process
Evaluation of equipment calibration/verification, maintenance, and use
Evaluation of training documentation
Evaluation of laboratory compliance with safety regulations
Evaluation of Computer Systems