Use of a CAPA System in Handling Anomalous Bioanalytical Results
Posted on Tue, Jan 03, 2012 @ 07:38 AM
Use of a CAPA system in handling anomalous results – with a focus on maintaining GCP compliance. A CAPA (corrective and preventative action) system is a useful tool in managing anomalous results. The advantage of a CAPA system is that Quality Assurance become responsible for monitoring the progress of the investigation and ensuring it is documented correctly and closed out in a timely manner. Also, if an electronic CAPA system is used it is possible to monitor trends in the nature and frequency of anomalies and report these to management.
Anomalous Bioanalytical Results
At Quotient Bioresearch a CAPA system is used more widely to deal with any “unexpected event” that may put a study at risk. As well as anomalous bioanalytical results more general events are also captured. These could include equipment problems, supplier problems, receipt of unexpected samples, poorly labelled samples or potential study unblinding.
GCP Compliance
A CAPA system can be of benefit in maintaining GCP compliance. The recent EMA guideline on Bioanalytical Method Validation states that analysis of clinical study samples (and the associated method validations) should be performed in compliance with GCP. In the UK it has been a requirement for some time now to conduct clinical samples analysis studies to GCP. At Quotient Bioresearch we have found the CAPA system to be an effective mechanism for managing potential serious breaches of GCP and ensuring they are communicated in a timely manner.
During the 2011 EBF Open Symposium Rachel Green, Client Manager within Bioanalytical Sciences at Quotient Bioresearch presented on Use of a CAPA system in handling anomalous results - with a focus on maintaining GCP compliance.
Request a copy of the presentation to find out about how:
- within a GCP setting unexpected results can be a compliance issue
- a CAPA system is a useful tool in managing investigations and ensuring actions are completed
- in a clinical study, unexpected results could indicate mis-dosing or differences in metabolism that could put the safety of subjects at risk
