Since 1999, we’ve been audited 19 times by the MHRA for GCP and/or GMP. In our last routine GCP inspection (2018), we had no critical or major findings. In the previous inspections (2011, 2013 and 2015), we had no critical or major findings. Notably, in 2013 we had no GCP-related findings whatsoever – an unprecedented outcome in the history of MHRA inspections. Our excellent track record led the MHRA to increase the interval between inspections to 3 years. In our last 2 routine GMP inspections (2014 and 2017), we had no critical or major findings.
In 2017, we had a week-long inspection by the USA Food and Drug Administration (FDA) for 2 pivotal trials. The auditor was impressed by the quality of our facilities and data, and raised no findings.
Our quality management system includes over 900 SOPs and forms, and incorporates the requirements of EU Directive 2001/20/EC; The Medicines for Human Use (Clinical Trials) Regulations 2004 (and current amendments); ICH GCP and GMP3; EU Directive 2005/28/EC; and the SOPs issued by the Research Ethics Service for Research Ethics Committees in the UK.
The HMR Quality Team comprehensively and independently audits our systems, facilities, subcontractors, laboratory, and pharmacy. Auditing of trials ensures that our work and results are of a high standard, and comply with all relevant guidelines. For each trial, our QA auditors audit the following.
- Pre-trial: master file, pharmacy trial file, and key documents prepared by HMR, which may include protocols, information and consent forms, and blank Case Report Forms (CRFs)
- During the trial: 100% of data in a sample of CRFs, trial procedures, and pharmacy procedures and records. The frequency of audits depends on the trial’s complexity and duration
- Post-trial: trial master file, pharmacy trial file, and the clinical trial report
- The trial database, and the tables, figures and listings, if applicable
We follow up each audit to ensure that all queries have been satisfactorily resolved.