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PHSS News | Open Access | Published April 2024



PHSS News


PHSS News – Spring 2024


On 11th and 12th March we hosted Sterile Product Manufacturing and Aseptic Processing conference. This brought together over 70 attendees, supported by our speakers and exhibitors to deliver an engaging conference. Over the two days we heard from 14 excellent speakers, sharing their insights, perspectives and guidance for delegates on how to navigate the challenges. We also enjoyed an engaging Networking dinner on Monday evening to allow attendees valuable time for those individual questions and discussions.

 

Some highlights to note:

 

  • Martine Powell (MHRA) shared insights into how Annex 1 is being implemented, with a recommendation to focus on CCS being not only in place but also proactively used.

  • Malcolm Holmes covered the regulatory update provided by PHSS which distills the most recent regulatory updates covering all pharma into a useable tool to inform colleagues and management on the challenges ahead.

  • Many more thought provoking presentations on how to build a new facility , real life considerations for rapid method introduction.


Full topics covered were:

  • Challenges to particulate counter installation and qualification to manage particle loss in sampling and strategies to address them, by Julian Kay from GSK.

  • Implementation of a new isolator-based filling line for sterile fill-finish of vial vectors, by Leslie Southam from Oxford Biomedica.

  • Practical validation/application of Enzyme Indicators in vH202 surface decontamination, by Birte Scharf from Franz Ziel GmbH.

  • Forming confident connections in fluid pathway, by Katie Church from Watson Marlow.

  • Regulatory Insights discussions, by Malcolm Holmes from PHSS.

  • Panel’s perspective, including MHRA and leading SMEs to answer questions submitted by the attendees during the day (some received in advance).

  • MHRA views on GMP impact and assessment processes, by Martine Powell, MHRA Expert GMP Inspector.

  • Risk management of contaminants in gowning in future sites, by Matts Ramstorp from BioTekPro.

  • Flexible manufacturing – facilities for multiple processes and scales, by Andrew Besso from eXmoor Pharma.

  • Annex I and ISO TR14644-21, by Gordon Farquharson from Critical Systems Ltd.

  • Challenges with transferring to ATMP, by Tamryn Hassel.

  • Rapid methods vs. conventional implementation, by Tim Sandle, BPL.

  • VR presentation and demonstration, by Stephen Steward from Catapult GCT.

  • Annex I updates – QRM principles and risk based holistic implementation, by Di Morris, PHSS/PNR/Pharma (ex-MHRA)

 

A thoroughly engaging event and enjoyed by all "This Conference reflects the hard work of the organisers to ensure relevant topics are brought into the room. Communication leading to the day of the conference has also been great and the same after the conference. The venue was great too and the space well used. The Conference has added an immense value on knowledge and ensuring we keep up to date with so many emerging regulations and new developments. Thank you!"


"I think it was a fabulous event, I learned so much about the challenges in the sector. I think the organisers should be proud."


"Great cross section of people from the industry. I loved it"

 

With PHSS membership at £120 + vat a year it represents great value. Students / young professionals get a discounted rate  (£25 + vat ) making it a no brainer to join our dynamic society . If you represent a large corporation , group membership is £575 + vat which gives your teams and leadership a great way to access other intersected parties and have routes in to the advocacy journey through a recognised industry third party . Please contact info@phss.co.uk for more details or go to the www.phss.co.uk website and Join now

 

A reminder to visit the resources hub and repository on the PHSS website to access a wide range of useful information including the guidance documents and templates to support the development of Contamination Control Strategy documents, please click here to access CCS Guidance.

 

Please remember to keep connected so you are up to date with all PHSS activities and events.

 

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

 

Jenni Tranter,

PHSS Chair

March 2024

               






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