PHSS News | Open Access | Published July 2025

PHSS News

We recently held the Sterile Conference, kindly hosted by AstraZeneca, on 25^th & 26^th June.

The event began with a tour of the AstraZeneca facility in Macclesfield, followed by a Networking dinner. The next day, we hosted the one-day conference at the AstraZeneca offices.

We commenced the day with a welcome and safety briefing from our hosts. The agenda was adjusted slightly to accommodate Ian Rees' schedule change, allowing him to join us virtually.

We opened the presentations with Kevin Bailey, GMP Inspector at the MHRA, who provided updates on useful resources available to the industry and partnerships in place with the Access Consortium. Kevin highlighted the importance of being ready for inspections when a submission is made. Key focus areas in the presentation included deficiencies identified during inspections and their frequency of occurrence, as well as AstraZeneca's approach to "Data-Driven Sterile Manufacturing: Exploring How Data Transforms Sterile Manufacturing Processes."

Next, we heard from Ian Rees, MHRA, on Decentralised Manufacturing.  Ian provided guidance on degrees of change and actions required. Also sharing the latest information on point-of-care and modular manufacturing. The legislation was amended (Statutory Instrument 2025 87) on January 23rd and comes into effect on July 23rd, 2025. This has challenges for the manufacture of sterile products.

Following a break and networking opportunity, we heard an engaging presentation from Paul Parsons, Astra Zeneca, on Data-Driven Sterile Manufacturing - Explore how data transforms sterile manufacturing processes. Paul discussed the importance of considering all data sources together, rather than in isolation, highlighting nine areas that could be involved. Reminding the audience that CCS is critical and is therefore mentioned over 70 times in Annexe 1, Paul continued to pose key questions to the delegates. Also he included a reference to acknowledge that data review is time-consuming and does require a cross-functional approach. The use of AI in the future was discussed, with a caution about not relying solely on this technology.

After lunch, Darren Jones from EPIC (ExPharmaceutical Inspectors Consortium Ltd.) presented on current failure modes and root causes in sterility assurance. Darren shared several examples (case studies) to highlight key challenges, common themes, and root causes. These included the lack of knowledge of the process and expertise, the importance of not relying on suppliers, the importance of knowledge, experience, and understanding, and whether the equipment is well contracted and operated correctly.

The next speaker was Andrew Gravett from AstraZeneca, sharing insights on the use of Robots for Cleanroom disinfection. Learn about autonomous UV-C technology for enhanced contamination control.

The final presentation of the day was from Kirsten Heukelbach of Hammersmith Medicines Research, who shared the journey of an upgrade, the strategy and approach deployed, and the advantages and disadvantages of different aspects.

We concluded the day with a Q&A session to cover questions submitted throughout the day for the speakers.

Thank you to our Hosts AstraZeneca, key sponsors (Micronclean and BD), the speakers, all our exhibitors, the delegates and of course the PHSS Office for all the preparation in delivering a fantastic and engaging event.

''The tour was very well organised, with great communication of required information etc beforehand. Very informative a lot of time for interactive questions etc."

''Great detail and educational."

''I think the interactive speakers were very good."

''I loved the tour of AZ to see how big pharma can implement training and controls was fantastic. I enjoyed seeing innovation technology."

"The facility tour was excellent as were the presentations. Very interesting for me.''

''Thank you PHSS for such a great event."

'' I was really impressed with the event overall. There was a good mix of attendees, excellent presentations (interesting and informative) and an excellent location. Being with AZ was excellent - they were superb hosts and really looked after us. The level of participation from them and the quality of input really superb and I took a lot away from the event."

The next event will be the PHSS Annual conference, to be held on 16^th & 17^th September. Please book now to reserve your place on the tour, as limited places are available.

https://phss.glueup.com/event/phss-annual-conference-kindly-sponsored-by-biom%C3%A9rieux-138243/

QP Forum Conference 2025

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 activities and events coming from the PHSS.

Thank you, as always, to all our valued members, partners, and industry collaborations for your invaluable support. 

Best wishes to you all

Jenni Tranter,

PHSS Chair

July 2025