PHSS News | Open Access | Published 18th December 2025

PHSS News

Dear Members

This year seems to have flown by; we are now approaching the close of 2025.

We have hosted six fantastic events across the year, bringing together the membership, valuable partners and industry from the 2-day Aseptic Workshop in March, through to the most recent Scientific Insights webinar in November. We are focused on providing many ways to engage and share knowledge.

In addition to the core events, we have been dedicating time to developing further guidance documents to share with our Membership.

The following are available now:-

1.       PHSS Clarity in GMP guidance note Biological Indicators Version 2 - will be announced in the next week

2.       Airflow Visualisation Research: PHSS research on airflow visualisation and First Air protection using CFD modelling will be published in the December issue of EJPPS. https://www.ejpps.online/post/protective-airflow-in-aseptic-manufacturing-ensuring-first-air-integrity

3.       Risk Assessment Model: A new risk assessment model based on EM-FMECA (Excel) has been developed. This model complements the existing PHSS FMECA risk assessment for contamination control. Both contamination control and EM monitoring FMECA risk assessments will be covered at the upcoming PHSS QRM-PRM conference.

Coming soon:

1.       Biological Indicator Guidance: The guidance on managing quality variances, including handling rogue Biological Indicators (Bis).

2.       Isolators for ATMPs: Work is ongoing to prepare guidance on isolators for Advanced Therapy Medicinal Products (ATMPs). This will feed into: Isolators for ATMP guidance and the next Clarity of GMP guidance publication.

We are busy preparing a full schedule of events for 2026, and we encourage early booking to secure your place and avoid missing out on important opportunities to engage with SMEs, who will provide valuable insights and support knowledge development.

• QRM Conference 2026 – February 2026 Why Attend? - Understand the paradigm shift in QRM and PRM for Annex 1 compliance, learn practical tools to reduce subjectivity in risk assessments, prepare for regulatory scrutiny with robust CCS documentation

• CMC & GMP Training Course – February 2026 Why Attend? Develop a holistic understanding of CMC and GMP that's vital for regulatory readiness in today's evolving landscape. Enhance your expertise and stay ahead in the dynamic world of biological medicine and therapy evolution. Be positioned to navigate the complex regulatory environment that connects the many aspects of CMC and relevant ICH series of guidance with the paradigm shift in GMP following the revision and implementation of EU & PICS Annex 1 and ICHQ9(R1), enforcing the principles of Quality Risk Management (QRM) over a product life cycle.

• Aseptic Workshop -  25 March 2026 - More information to come

• Steriles Conference  - 18 June 2026  - More information to come

I wish all our members a very happy Christmas and New Year. Please stay safe and look forward to engaging with you all at one of our events in 2026.

Best wishes to you all

Jenni Tranter,

PHSS Chair

December 2025