Key Takeaways from the TCD QP Forum 2025

1. Sustainability and Regulatory Alignment in Pharma

Speakers: Catherine Mulhall, Michael Kilkelly, Brendan Griffen

With growing scrutiny on environmental claims, regulators now demand that pharmaceutical sustainability labels be backed by robust life cycle assessments. Notably, upcoming EU directives will impose levies based on packaging waste to reduce microplastics in water.

Key Takeaways:

• Manufacturing contributes more to carbon footprint than packaging.
• Optimising HVAC systems (e.g., feedback loops from particle monitoring) can cut energy usage.
• Robotics can reduce cleanroom personnel, minimizing contamination and improving sustainability.

1. Human and Organisational Performance

Presenter: Dermot O’Rourke

Human error is increasingly being framed as a symptom of systemic issues, not individual failure. Dermot emphasized building systems that minimize consequences of mistakes, such as through the use of physical barriers like isolators and RABs.

Cultural Insights:

• A blame culture suppresses improvement—promote accountability instead.
• Personnel involved in errors should lead CAPA efforts and share learnings.
• Encourage questions like: “What almost went wrong today?”

1. QP in the Digital World

Speaker: Peter Deegan

Transitioning from paper-based processes to digital platforms is reshaping the Qualified Person’s role. With Industry 4.0, the QP becomes a digital champion.

Innovations:

• AI-driven batch assessments
• Digital QP dashboards
• Sensor-based, inline verification
• Fully integrated Pharmaceutical Quality Systems (PQS) with real-time dashboards

1. Regulatory Insights from HPRA

Presenter: Paul Sexton

Key updates from HPRA’s 2025 agenda include:

• Draft revisions to Annex 11 (Computerised Systems) and Chapter 4 (Documentation)
• Expansion of Mutual Recognition Agreements (MRAs) to include vaccines and plasma-derived products
• Increased use of hybrid inspections and distant assessments
• Revised guidance on ATMPs, Annex 1, Annex 14, Annex 16, and new GDP drafting groups

Post-Annex 1 Inspection Focus:

• Contamination Control Strategy (CCS)
• Environmental Monitoring
• Personnel practices
• Decontamination processes

1. Releasing Challenging Products

Topics: ATMPs, OOT Batches, Orphan IMPs

Case studies highlighted the ethical and scientific complexity of releasing borderline products.

• ATMPs: Difficulties in applying GMP to academia-driven therapies using patient cells.
• OOT Batches: Stability testing decisions must be risk-based and data-supported.
• Orphan Intrathecals: Low batch frequency requires leveraging data from similar products to support QP release decisions.

1. Robotic Automation in Aseptic Processing

Presented by Amgen

Amgen demonstrated their pioneering use of collaborative robots (cobots) for tasks like automated tub rejection and sample plate handling post-VHP sterilisation.

Highlights:

• Gloveless isolators and robotic air sampling systems
• Compliance with Annex 1 Sections 4.4, 8.9, and 8.16
• Importance of engaging regulators during innovation

1. Trending Deviations and Complaints: HPRA Expectations

Speaker: Michael Sreenan

Trending is critical for proactive quality management but often falls short.

Common Deficiencies:

1. Lack of defined methodology for recurrence checks
2. Vague or inconsistent search criteria
3. Poor documentation in deviation records
4. Ignoring minor incidents which may indicate systemic issues

Best Practices:

• Define recurrence logic clearly
• Standardize terminology
• Include recurrence checks for all investigation levels

1. Industry Best Practices in Trending

Presenters: Johnson & Johnson & PCI

• J&J’s COMET system uses structured data fields to reduce variability.
• Trending includes risk assessment and MA alignment.
• PCI uses MasterControl with manual trending but aims to automate this process.

Conclusion: The Future is Digital, Accountable, and Sustainable

The 2025 TCD QP Forum showcased how the QP role is evolving—from a document reviewer to a digital enabler and strategic risk manager. With regulatory frameworks advancing and technology rapidly transforming operations, staying agile and informed has never been more essential.