In September 2024, industry peers gathered at the PHSS Conference to discuss crucial topics shaping the future of pharmaceutical manufacturing and quality assurance. As a validation service provider, we found it particularly interesting to see how the quality assurance landscape was changing, learning from the way other companies are implementing and interpreting new guidelines and technologies. We hope this will help us answer questions we get from our clients with a holistic view. This article is split into key takeaways from several thought-provoking presentations, offering valuable insights for professionals in our field.
Global Compliance and Quality Risk Management: The Power of Collaboration by Graham Carroll, Lead Senior GDMP Inspector at the MHRA
Graham emphasised the importance of collaboration within the industry. He shared how international agreements between regulatory bodies are streamlining inspection processes, potentially reducing the burden on both regulators and pharmaceutical companies.
Carroll outlined four key elements for effective collaboration:
- Clearly defined roles and responsibilities
- Clear communication
- Effective training systems
- Well-developed processes and procedures
These principles, drawn from Carroll’s experience with the Royal National Lifeboat Institution, provide a solid foundation for improving industry-wide cooperation.
Managing Outsourcing Risks in Pharma by Phil Rose of Rose Pharma Solutions
Phil Rose, a former lead senior MHRA inspector and Quality Consultant, addressed the critical issue of managing risks associated with outsourcing in the pharmaceutical industry. With outsourcing becoming increasingly prevalent, especially in the Advanced Therapy Medicinal Products (ATMP) sector, Rose offered valuable advice:
- Understand your company’s weaknesses before outsourcing
- Don’t automatically choose the cheapest option
- Verify credentials and seek peer recommendations
- Assess and audit potential partners based on criticality and monitor their performance over time.
- Develop comprehensive quality /technical agreements (QTA)
- Ensure you have an expert in before you need them to avoid firefighting problems later.
Rose also highlighted some of the common issues he encounters, including problems with autoclaves, isolators, and cross-contamination, emphasising the need for vigilance in these areas, particularly when units have failed multiple times during validation. He stressed that getting 5 or 6 failures before a pass on an autoclave does not mean that all is ok.
Quality Risk Management in Aseptic Processes by Tracey Moore of TM Pharma Group Ltd
Tracey Moore, a former MHRA Inspector, stressed the importance of ICHQ9 (R1) in quality risk management, which directly informs Annex 1 requirements. Moore emphasised that proper design of processes, equipment, and facilities is fundamental to success, followed by well-designed procedures and monitoring systems.
Key points included:
- Avoid using quality risk management to justify unacceptable practices
- Base decisions on facts, not assumptions
- Utilise cross-functional teams for risk assessments
- Ensure data is accurate, reliable, and unbiased
- Plot out processes that need risk assessments to fully understand what you know and don’t know
- The challenges of using numbering systems in risk assessments.
The True Cost of Poor Quality by Jim Filer, Director of Quality Blueprint Ltd
This presentation highlighted the often-overlooked costs associated with poor quality. Beyond obvious expenses like rejects and recalls, Filer pointed out invisible costs such as customer defection, high employee turnover, and reputational damage. He stressed the importance of fostering strategic alliances between quality departments and corporate leadership to address these challenges effectively.
Airflow Visualisation: A Critical Tool for Contamination Control by Gavin Wandsworth, Director of VQ Ltd
Gavin provided insights into the crucial role of airflow visualisation in maintaining clean room integrity. With the recent updates to Annex 1, this topic has gained increased attention. Wandsworth explained various methods for visualising airflow, including schlieren testing and tracer methods using glycol particles.
Key points included:
- The importance of airflow visualisation studies (AVS) in building a Contamination Control Strategy (CCS) and protecting patients.
- Common general issues to look for in AVS, such as turbulence, static airflow and negative disruption from people, doors and equipment
- More elusive but important issues to look out for with the way AVS are conducted eg. not including simulations of all activities or omitting important information from video documentation.
- Best practices for conducting and documenting AVS
The Future of Aseptic Filling: Next-Generation Robotic Platforms by Austin Lock, PM Group
This presentation provided an exciting glimpse into the future of aseptic filling technology. In collaboration with the FDA Emerging Technology Programme, PM Group is developing a robotic, completely gloveless filling line. This innovation aligns with Annex 1’s encouragement of automation and engineering solutions to minimise human interventions in aseptic processes.
Conclusion
The PHSS Conference 2024 provided valuable insights into the evolving landscape of pharmaceutical manufacturing and quality assurance. From the importance of global collaboration to cutting-edge robotic technologies, these presentations highlight the industry’s commitment to continuous improvement and innovation. For more information about the PHSS, please visit https://www.phss.co.uk/.
As we move forward, it’s clear that staying informed about these developments and implementing best practices will be crucial for maintaining high standards of quality and efficiency in pharmaceutical production. Should you wish to discuss any of these topics from a validation angle, please do not hesitate to reach out using our contact form.
