GCP Inspection Findings published
Recommendation

28/29 April 2026
From QbD to Process Validation
The U.K. Medicines and Healthcare Products Regulatory Agency MHRA has compiled a GCP Inspections Metrics Report. This report summarises 125 GCP Inspections which were undertaken by the MHRA GCP Inspectorate from 1st April 2013 to 31st March 2014. Now, almost two years later, this interesting overview was published.
When looking at the data, the importance of a robust Quality Management System becomes obvious. Observations in this area are number one for CRO Inspections and number two for Non-Commercial Sponsors closely behind Clinical Trial Oversight. All findings are listed as major grading.
Related GMP News
20.01.2026FDA Qualifies First AI Drug Development Tool
20.01.2026Update on ICH Efficacy Guidelines E22 and E23
11.12.2025Insurance Review in Phase 1 Clinical Trials
11.12.2025EMA Publishes Comments on ICH E21
27.11.2025Final ICH M14 Guideline on the Use of RWD for Safety Assessment
25.11.2025Clinical Trials: BMG publishes Standard Contractual Clauses Ordinance


