Editorial | Open Access | Published 14th July 2022
This year marks a momentous milestone for the Society, as we reach our 40th year! We will be sharing insights from our history and taking the opportunity to celebrate at the Annual Conference in September. Please keep connected with our various channels, looking out for further information on how we will be celebrating this and sharing some highlights from the past 40 years.
In June we hosted the virtual Sterile Medicinal and ATMP Product Manufacturing Conference, focusing on the paradigm shift and the changes in GMP regulation and support for this new paradigm.
We had four fantastic presentations highlighting the importance of risk mitigation, knowledge, and key considerations for your CCS from Di Morris, PHSS Co-Lead A3P-CCS Guidance and PHSS Co Vice chair, James Drinkwater, Franz Ziel Head of GMP Compliance and PHSS Co-lead A3P-CCS Guidance, Dr Félix Julian Montero Biomerieux and Edward Webber, Microgenetics UK.
Di started the day focusing the importance of governance and quality oversight when preparing your CCS. Also do not forget to listen to the operators, they have good knowledge and insight has to how the facility works. Di went on to discuss the ICH rules of the game and the biggest change being on the impact of subjectivity. Decisions should be based on science and fact not opinions. This is a fundamental shift in regulator expectations. A key challenge is addressing bias and behavioural factors, this is where training and knowledge are vital! Assessments should involve Risk and Hazard, analysis and mitigation.
James followed Di, with a presentation on Barrier Technology, consideration the advantages and challenges associated with integrating automation and robotics. Again, bringing the focus to risk mitigation and reinforcing risk assessment and hazard identification. James went on to discuss the importance of application of knowledge. Review and consider everything coming into the cleanroom, then how that moves into the specific barrier technology. Each Vector needs assessing! James highlighted the difference between RABS and Isolator requirements, as more and more they are being recognised as being separate.
Dr Montero then shared key insights into the bioprocessing production market, highlighting where benefits (and value) can be delivered in reduced timelines by using rapid micro methods.
Microgenetics provided a through overview of all elements for consideration that need to be included in the CCS, as well as the importance of good collaboration with a cross functional team of SMEs to develop the ccs.
We are now busy preparing for the Annual Q3P Conference in London on the 15th September and look forward to welcoming members back together for our first face to face event since 2019. This year’s conference will focus on Challenges in Biological and Advanced Medicinal Therapeutic product ATMP manufacturing with GMP compliance, where we will be bringing presentations and panel discussions from Key Opinion Leaders and Subject Matter experts to share their experiences and insights with our membership.
We will also be taking the opportunity to have a more formal celebration of our 40th year, so will be inviting members to join us on the evening 14th September for a networking reception. Further details can be located on our website https://phss.co.uk.
Please remember to follow us on social media to keep up to date with the latest news.
Thank you finally to all our valued members, partners, and industry collaborations for your invaluable support.
Jenni Tranter, Chair of PHSS – Pharmaceutical & Healthcare Sciences Society.