Editorial | Open Access | Published ?

PHSS News - September 2019

Hello, my name is Jenni Tranter and I am very pleased to take up the position of Chair for the PHSS. I have been the Vice chair since July 2015 and have been an active member of the Management Committee since joining in November 2013.

So, a bit more about me. I have been working in Healthcare and Medical Industries since August 1998, after graduating from UWIC in 1998 with BA(Hons) in Business Management. I worked for Healthcare manufacturers prior to joining STERIS AST in May 2003, as a Regional Sales Manager, then in 2009 became Marketing Communications Manager, transitioning to Business Development Manager in 2013 before moving into my current role of Senior Marketing Manager in 2016. In my role with STERIS I am involved in a wide variety of areas, from strategic planning, supporting acquisitions and integrations to running global projects looking after our Customers Experience. On a daily basis I am responsible for all Marketing activity conducted within the EMEAA region. This involves engaging with colleagues and Customers, managing projects ranging from Market segmentation/development, Competitor surveillance, Event & CRM Management to Brand values and Employee engagement initiatives.

I am excited to continue the excellent work conducted by the PHSS, I believe we attract some of the best thought leadership and opinion influencers in our industry. The PHSS’ focus is entirely on its members, delivering, practical guidance to support its membership. The membership fee is of incredibly good value given the resources, information, events and networking opportunities that is provided each year. PHSS is the go-to Society for assistance with the challenges associated with regulatory change and manufacturing.

We will be continuing with the excellent foundations and strategic direction set by James Drinkwater our outgoing Chair. I look forward to working with all our members and supporters to deliver great education events, bringing exceptional value to our membership and the industry.

As you can read, I bring something different to the society, however I am keen to follow in the footsteps of a very credible individual who has directed the society well over the last 10 years. I am confident that my 21 years of industry experience, has a solid base, to give full appreciation for industry requirements and serve our membership well.

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PHSS Activities and initiatives EJPPS report September 2019

By James Drinkwater - Head of PHSS Aseptic processing and Containment Special interest group

The PHSS Annual conference on 10 September 2019 had a focus around the challenges of manufacture and certification/ release of advanced therapeutic medicinal products (ATMPs) and Biological products. There was a real insight provided to what Gene and Cell therapies are and the challenges in manufacture and cross contamination control.

The challenging role of the QP was discussed where products or therapies use biological delivery systems being autologous or allogenic (single patient or targeted patient groups) where the significance of cross contamination control adds to the classical requirements of contamination control in sterile product manufacture.

The role of the QP and challenges in product certification for release will be further discussed at the annual PHSS QP Forum in Wales November 2019 – details on the PHSS Website.

The Annual conference in London also included an update on the PHSS initiative in preparation of Clarity on GMP Guidance notes of which there are sixteen in preparation. The key points to be included in each guidance note were presented with the slide deck available from the PHSS office. Focus groups are now appointed to prepare the guidance notes so drafts will soon become available. The full PHSS Aseptic processing special interest group will review the drafts before finalization and issue to the MHRA for regulatory review before publication on the PHSS Website.

Planning is now in progress for 2020 Aseptic processing workshop syndicates and Annual Challenges in Sterile product manufacturing conference in Manchester UK April and June respectively. These are typically sold out events so those interested should contact the PHSS as soon as information is released.

The PHSS has increased the management team skill set/subject matter experience to extend to non-sterile product manufacturing where bioburden control is required. Information on the initiative to extend support in non-sterile product manufacturing over sterile product manufacturing GMP, that the PHSS is well known for, will be shared in the next issue of the EJPPS.

Annex 1 revision status. It is now understood from various sources that there is a draft version of the Annex 1 revision that is the outcome of the consultation process (revised from the published draft to reflect industry comments) and after review may be published early 2020. This statement is not official but just an insight to current information as the industry awaits this important publication. There is also talk of a ‘targeted’ consultation process on key points of Annex 1 that may form part of the review process before publication. There still remains rumors and myths around Annex 1 publication so still uncertainly remains on the final content and publication date but hopefully we are now closer to the end of this long process of revision and all involved in sterile product manufacturing can finally complete a gap analysis to identify shortfalls and address new regulatory guidance and expectations under the increasing requirements of Quality Risk Management (QRM).