GMDP Deficiency Trends: Key Compliance Gaps and How to Address Them
The MHRA last published GMP deficiency data in 2019 and GDP deficiency data back in 2016. In the absence of any recent data published by MHRA, EPiC have trended deficiencies which we have identified during our own audits and mock inspections, since January 2024.
These findings reveal persistent gaps that pharmaceutical companies must address to maintain compliance and protect patient safety.
The State of GMDP Compliance
Current GMDP Compliance Trends and Audit Findings
EPiC’s audit findings from 2024–2025 closely mirrors the MHRA’s last published GMP data from 2019, showing there has been little progress by the pharmaceutical industry in addressing significant gaps.
The top three deficiency references remain unchanged:
1. Documentation & Data Integrity
Examples include:
- Records not completed in real time
- Weak controls for electronic documents, including inadequate system validation and audit trails
- Poor adherence to ALCOA+ principles
2. Deviation Management & Root Cause Analysis (RCA)
Examples include:
- Investigations lack depth and structure
- Root causes not identified resulting in recurring issues
- CAPA not identified or implemented to address the root cause
3. Change Control including post implementation evaluation.
Examples include:
- Changes not fully assessed to identify all required actions
- Missing post-implementation reviews
Other recurring issues include insufficient management reviews, inadequate training programs, and storage deficiencies.
Why Do These GxP Gaps Persist?
Root Causes Behind Persistent GMDP Deficiencies
During the EPiC 2025 GMDP Symposium, an anonymous audience poll was conducted to ask delegates their thoughts on reasons for these gaps. Here are the top reasons provided:
1. Resource Constraints – Examples: Lack of resources, staff shortages, capacity issues, no bandwidth for improvement, firefighting other issues, lack of SME resourcing, under-staffed/resourced.
2. Quality Culture – Examples: Poor quality culture, quality seen as unnecessary cost, lack of continuous improvement activities.
3. Senior Management Engagement – Examples: Lack of senior management involvement, leadership not liaising with ground level, focus on cost over compliance, inadequate commitment.
Looking Ahead: Strategies to Improve GMDP Compliance and Reduce Deficiencies
The pharmaceutical industry must move beyond reactive compliance and embrace a proactive, risk-based approach to data integrity, deviation management and change control.
Senior management are ultimately responsible to ensure an effective Pharmaceutical Quality System is in place and adequately resourced. The company’s quality culture is set by senior leaders; get this right and it will not only reduce regulatory findings but also safeguard patient health.
Need Help Closing Compliance Gaps?
EPiC offers expert support to strengthen your compliance framework:
- Mock Inspections to help identify PQS failings
- GMDP Training Services to senior leaders to ensure they understand their responsibilities
- Data integrity, root causes analysis and change management training and coaching.
Contact EPiC today to strengthen your GMDP compliance and minimise regulatory deficiencies.