PHSS News | Open Access | Published December 2023

PHSS News

PHSS News – December 2023: Winter update

This year we have run our Sterile and Aseptic Processing Conference in June, Annual Conference in September and the latest of the events, the QP Forum Conference, in November.

The first PHSS QP conference was held on the 1st of November 2012 in the magnificent Llangoed Hall, near Brecon, Wales.   The PHSS has hosted this conference every year since on the first Thursday in November.   This year it was in Usk, Wales, on the 2nd of November 2023.

The conference is not just for QPs but for anyone in the pharmaceutical industry who wants to keep up to date with new technology and new regulatory expectations.

The conference started with Di Morris (PNR Pharma Ltd) talking about both the need to keep up with new technologies and with recent changes in ICH Q9.  Pam Turner (PNR Pharma Ltd) reviewed the recent trends in FDA 483’s and warning letters.  Marton Dooley (QP Solutions Ltd) talked about Heral Medicines and Alan Heavey (Sterilization Solutions Ltd) considered the lessons still being learnt from the Clothier report (1972) after the sepsis deaths in the Devonport section of Plymouth Hospital.

In the afternoon Peter Deegan (RSSL) discussed remote audits and Gordon Farquarson (Critical Systems Ltd) talked about the Pharmacopoeias and Water for Injection, EUGMP Chapters 3 and 5 in relation to cross contamination.

As usual there was a wide range of topics, with time at the end of the day for a discussion panel with the speakers.

Next year the conference is planned for Thursday the 7th of November in Usk, Wales.  Already, we have an exciting panel of speakers who will cover interpretation of regulations, of new technology, new products and processes.

Following the June event, the much-awaited Contamination Control Strategy (CCS) practical guidance was finalised ready to make available to PHSS members and industry. For more information, please go here CSS Guidance.

For more information on all our events please visit the PHSS website and follow us on social media.

EJPPS

The Journal, established more than 20 years ago by the PHSS, continues to provide insightful articles for our membership. It contains peer-reviewed scientific and technical papers from the pharmaceutical and healthcare sciences. By contributing articles to the Journal this is your opportunity to drive change.

We invite articles and scientific papers that test, disseminate, validate, and publicise changes. The areas that the EJPPS specialises in are the parenteral and pharmaceutical sciences. It is about where and how we make pharmaceutical products and medical devices, how and where we test them, how and where we use them and the regulatory environment we work within. It is also about the hospital sector. Increasingly, this is where we make and test products but, more importantly, it is where we use the products we make.

There are several aspects to the journal, including peer-reviewed scientific papers. Scientific papers should focus on scientific experimentation and reference other scientific literature to create and test a hypothesis. These are peer-reviewed by subject matter experts from the International Review Board.

The other section is Science and Technology Features. This includes reviews of regulatory updates, book reviews, conference reviews, technology reviews, industry reviews, best practice reviews and updates on the PHSS Special Interest Groups. These are reviewed for publication but do not always require subject matter expert reviews.

We call for papers and articles that you would like to see included in the journal. This is your opportunity to drive the changes in the world we work in.

Membership: There are many reasons to be part of the PHSS:

• Network with industry subject matter experts and key opinion leaders.

• PHSS-exclusive monthly regulatory update synopsis, providing a one-stop shop.

• Access to an extensive library including CCS Guidance documents, white papers, and Impact statements.

• Free to member conference and discounted rates for other events hosted throughout the year.

• Opportunities to join special interest groups to develop practical guidance on key industry topics.

• Quarterly online peer review copy of the EJPPS Journal.

On behalf of PHSS we wish you all the very best wishes for the festive period and look forward to connecting with you all in 2024.

Jenni Tranter,

PHSS Chair

December 2023