PHSS News | Open Access | Published January 2023

PHSS News

Welcome to 2023 and Happy New Year everyone.

As we begin the year, we are straight into planning the Aseptic Processing Workshop. The 2023 event will be completed over two consecutive days 28-29th March 2023 at Moor Hall Hotel and Spa, Nr Birmingham, UK

The focus of the training will be key points for compliance to the revised EU GMP Annex 1 and applied contamination control and monitoring measures to be documented in a Contamination Control Strategy (CCS).

Each training day will commence with a Keynote presentation. This will set the scene and open discussion points in the workshops throughout the day.

· Day One – Keynote: Legacy v’s New Build – How are you navigating this?

· Day Two – Keynote: Particle Monitoring Practical Guidance – How can you comply to the revised Annex 1 by August?

Training topics include:

· Premises – Site & Room

· Personnel

· Production and specific technologies

· Environmental and Process Monitoring

· Quality Control

· Equipment and Utilities

· Life cycle of Environmental Classification, Qualification, EM & Process monitoring and re-qualification.

Each of the workshops will include key points to consider to be documented in your CCS.

All participants will benefit from the knowledge shared and connection of GMP requirements and QRM principles to applied sterile product aseptic manufacturing and control measures that are applied to meet Annex 1 requirements.

For more information, please look out for updates on social media and the PHSS website www.phss.co.uk

As part of our membership drive, we are preparing to introduce a Young Professionals focus group, looking at how we can engage further with a wider audience, supporting people in their

career development and building knowledge in the industry. More information will follow as our plans and activities develop, please also contact us if you would like to be involved in supporting this group.

We are also looking to strengthen our office team and are currently recruiting for an Operations and Marketing Executive, to support the society moving forward in 2023 and beyond.

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

Jenni Tranter

PHSS Chair

January 2023