MHRA: Guidance for GLP facilities on the implementation and maintenance of a risk based Quality Assurance programme

The purpose of the MHRA document is to provide GLP test facilities with guidance on what should be considered when implementing a risk based GLP Quality Assurance (QA) programme. This document discusses the expectations of the UK GLP Monitoring Authority related to the use of a risk based QA programme and includes information on quality control activities that may be used to support it.

For example, where a manual transcription process is in place the introduction of a QC check at the time of transcription increases the detectability of any errors and reduces the risk of incorrect data being used in a calculation. In this specific case the use of a validated computerised system would further reduce the residual risk, where direct transfer of data from one system to another may be performed without the need for additional QC checks.

Read it online here.