PHSS News | Open Access | Published 27th March 2026

PHSS News

Dear Members

It has been a very busy start to 2026. We continue to work hard to bring important and engaging opportunities to the membership and the wider industry, facilitating events that help you connect, develop, and deepen your knowledge.

We were excited to announce that on Friday, 6^th February, a team from the PHSS completed a training session for the USA FDA CBER, with around 100 in attendance.  The training focused on Airflow visualisation of protective airflow, including First Air as a critical measure for airborne contamination control in aseptic manufacturing.  This training followed a PHSS research study using the science of Computational Fluid Dynamics (CFDs) to build knowledge of the profile and associated risks in airborne contamination control and the role of CFDs alongside the formal qualifications of ‘Smoke study’ visualisations. Together with the research presentation, discussions were initiated on characterisation of protective airflow and Rules for First air compliance in line with Annex 1 requirements ahead of the revision of the PHSS Airflow definition guidance to include protective airflow, First Air (new) alongside (existing) UDAF, Localised UDAF and Grade A Air Supply and the much needed new definition of CNC: Controlled Not Classified areas. 

PHSS intent is to roll out this Airflow visualisation regulator training to other international regulatory authorities, alongside developing a PHSS online training course for all stakeholders. It is considered important that the Pharma industry, ATMP sectors, and others involved in the application of protective airflows keep up to date with these developments in line with the knowledge shared with regulators. 

Also, in February, we hosted two events focused on Risk Management, CMC and GMP.

PHSS Quality and Process Risk Management Seminar Workshop, hosted by Di Morris, James Drinkwater and Alf Penfold.  It was an insightful day, with discussions on regulatory expectations and the key updates in ICH Q9 (R1) — including hazard identification, managing product availability and supply risks, reducing subjectivity, understanding the appropriate level of formality in QRM, risk‑based decision making, and effective risk reviews.  The Seminar also covered practical case studies on applying QRM to ATMPs, risk‑based contamination control models and how to build strong, compliant Contamination Control Strategies.

The PHSS Chemistry, Manufacturing, & Controls (CMC) & GMP, with a specific focus on Biologics & Advanced Therapy Medicinal Products (ATMPs) 2-day Course. Hosted by James Drinkwater and David Murray. The two-day event focused on the importance of understanding the connection between CMC and GMP needs so that characterised Critical Quality Attributes: CQA's, Critical Process Parameters: CPP's and the Quality Analytical Profile: QAP are fully GMP compliant when reaching the market. Control strategies are required for Product manufacturing, Contamination Control, and cross-contamination control, with CMC and GMP remaining connected through these strategies.

We are also looking to the future and already planning events for 2027.  Please see the details below for what is coming up…

2026

·       Aseptic workshops 2 half day (virtual) 28^th & 29^th April (2hrs/day)

·       Airflow visualisation (virtual) 

o   18^th /19^th May 09:00 - 12:00 BST

o   29^th/30^th June 13:00 - 16:00 BST

·       Sterile Product Manufacture Conference – 18^th June

·       Annual Conference – 16^th September SAVE THE DATE

·       QP Forum – 5^th November 

2027

·       Radio Pharmaceuticals (virtual)

·       Contamination Control Strategy (CCS) Training (virtual)

·       Aseptic workshops 2 half day (virtual) - April

·       CMC/GMP (virtual)

·       Sterile Conference – June

·       Annual Conference – September

·       QP Forum – November

If you are interested in any of the above events, please contact us for more information. https://www.phss.co.uk/event/ phssasdmin@phss.co.uk

*** STAY CONNECTED***{JOIN NOW} BECOME A PHSS MEMBER: GREAT MEMBER BENEFITS

• PHSS-exclusive monthly regulatory update synopsis, providing a one-stop shop

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• Informative events and publications at discounted prices

• Access to an extensive document library, including white papers, Impact papers and process discussions

• 30-day free digital access to the latest Technical Monographs

• Quarterly online peer review copy of the EJPPS Journal

We look forward to engaging with you all at one of our events in 2026.

Best wishes to you all

Jenni Tranter,

PHSS Chair, March 2026

Pop along and see us if you are visiting. James Drinkwater will be presenting.