Production, Approval and Review of SOPs

The Medicines for Human Use (Clinical Trails) Regulations state that Clinical Trials involving medicinal products MUST be authorised by the MHRA and conducted according to the Principles of GCP as defined in the Regulations and any amendments.

MHRA GCP Inspectors assess compliance with the requirements of GCP by conducting inspections at the sites of pharmaceutical sponsor companies, contract research organisations, academic research organisations, investigational trial sites, clinical laboratories, GCP archives and other facilities involved in clinical trial research. Mandatory GCP inspections will be conducted in both commercial and non-commercial organisations within the UK.

SOPs covering all key aspects of Clinical Trial function are a key component for adherence to the principles of GCP and are monitored for quality assurance and compliance with the Regulations.

This Standard Operating Procedure (SOP) describes the process for writing, implementing and reviewing KHPCTO SOPs.

SOP: Production, Approval and Review of SOPs (2.4MB)

Related Documents

SOP Template V5.0 (.doc 1.3KB)