Production, Approval and Review of SOPs

Statutory Instrument 2004/1031 – the Medicines for Human Use (Clinical Trials) Regulations 2004 transposed the European Union Directive 2001/20/EC for Clinical Trials into UK law effective from the 1st May 2004. The original UK regulations were amended in August 2006 to incorporate the EU Good Clinical Practice Directive (2005/28/EC) as Statutory Instrument 2006/1928.

The 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 Amended Regulations and any subsequent 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 against for quality assurance and compliance with the Regulations.

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

SOP: Production, Approval and Review of SOPs (300KB)

Related Documents

SOP Template V4.0 (.doc 1.3KB)