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PHSS News | Open Access | Published April 2025


PHSS News


Welcome to the first PHSS News of 2025

 

We recently hosted the two-day Aseptic Processing Workshop in Leamington Spa. This provided delegates the opportunity to participate in 6 interactive sessions,

 

The day commenced with a thought-provoking and engaging   Keynote Presentation on  ICHQ9 and Annex 1 Considerations for Your Organisation from Di Morris, Ex-MHRA/PNR Pharma/PHSS Vice-Chair.

Delegates then moved into workshop sessions. Details of Days One and Two are shared below.

 

  1. Risk Assessment for Contamination Control in Support of CCS Preparation: Delivered by  James Drinkwater Franz Ziel/PHSS

  2. Best practices for particle monitoring in both legacy and new systems in. Delivered by Janice Wallace - Pharmagraph, Andy Worsick - PMS, Matt Kite - Lighthouse

  3. Annex 1 wider GMP between a large-scale pharmaceutical manufacturer and a small-scale startup or hospital aseptic unit delivered by Alex Bosely - Torbay Pharmaceuticals

 

The day concluded with a networking dinner for all attendees.

 

Day Two then resumed with workshops; details are below.

 

  1. Evolution of GMPs and their Importance in Aseptic Manufacturing delivered by Di Morris, PNR Pharma/ Ex- MHRA/ PHSS Vice Chair

  2. Critical Processes of Environmental Monitoring Rationale delivered by Rob Osborn & Ian Hudson, Thermo Fisher Scientific

  3. Understanding CCS – What is Your Understanding? Delivered by Niamh Bissett, West Pharmaceutical & Alf Penfold - PM Group

 

We concluded day two and the event with each workshop lead sharing their highlights and key takeaways from the discussions.

 

The event was a resounding success, delivering engagement and thought-provoking discussion.  Thank you to everyone involved!


"Welcoming and well organised - the workshops had the right amount of intensity with regular breaks to help consolidate concepts/ideas."

"The workshops had the right amount of intensity with regular breaks to help consolidate concepts/ideas."

"The workshops were excellent and very engaging and informative."

"Organized very well and went smoothly, interesting talks."

"Both days were excellent."

"The two days were fantastic. As someone new to CCS, I found all aspects knowledgeable."

"Well put together and good opportunity to meet one-on-one with other attendees."


Moving on to our next event, we are delighted to announce our collaboration with AstraZeneca to host the Steriles Conference. The conference will include a tour of the AstraZeneca facility and a networking dinner.

PHSS Sterile Product Manufacturing Conference 2025: Please reserve your spot now, as availability is limited.


This year's PHSS Annual Conference is in association with BioMerieux.

We will hold a site tour locally (TBC) and a networking dinner, which BioMerieux is sponsoring.

We will hold a conference on September 17th, packed with keynote speakers, industry SME, and MHRA (TBC).

Keep your eyes out for more details.


The Conference, being held on November 6th, is designed for all Qualified Persons and aspiring Qualified Persons. Given the challenges within the QP function in the past 18 months, listen and interact on topics and the latest developments regarding the duties and responsibilities of Qualified Persons. This annual event has been valuable to those in the QP role.


Please stay connected to keep up to date with all events and activities from the PHSS.

 

As always, thank you to all our valued members, partners, and industry collaborators for your invaluable support. 

 

 

Best wishes to you all

 

Jenni Tranter,

PHSS Chair

April 2025            





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