Editorial | Open Access | Published 15 June 2021

PHSS News

Dear Readers

We are progressing nicely through 2021 and we continue to work on bringing regular updates to the membership each month with impact statements and regulatory updates – please go here for the latest information https://phss.co.uk/

We recently hosted our Sterile Virtual Conference 15th & 16th June, thank you Tammy Hassel, from Lonza and PHSS MC Member for stepping in to chair the event in my absence.

On Day 1 we had a talk by Patrizia Muscus, a Senior Research Scientist at Eli Lily, who talked us through their five year in the making journey to install a highly successful entry/exit access control software. The talk reminded us all of the complexities in what we do day in and day out and how automation can help us better utilise the data we have access to, to control our facilities and process flows.

Di Morris from Astrazeneca and James Drinkwater of Franz Ziel Gmbh, both members of the PHSS management committee, then presented on various clarity documents being produced by the PHSS to help interpretation of GMP guidance documents. The day was finished off with a brief summary of the work being done by the PHSS and A3P on a contamination control strategy document, planned for release in September 2021.

Day 2 started with a talk by Microgenetics’ Managing Director, Andrew Davies, on what Industry 4.0 can bring to the Pharma industry and how software solutions, such as their environmental monitoring system, Smartcontrol, can aid in companies making the transition to automated solutions that meet the intense data integrity requirement expected to be overcome for industry. Through leveraging the power of AI, patterns can be identified and reported to analysts who can then spend more time focused on solutions rather than interrogation and interpretation of data.

Di and James then presented on a further three clarity documents, looking at barrier isolator leak integrity classes, and showed the value in understanding the risks that hide behind perceived good test results. They then moved on to the qualification of no touch transfer for the Grade A zone where filling of sterile products occurs, and finished off talking through justifications for extending implementation times of the revisions coming in the latest Annex 1 update.

The two days both ended with a Q&A session from the delegates to our presenters, and as always we had some tough but valuable questions to respond to. Another invaluable knowledge sharing session.

We are currently planning for PHSS Annual Conferences as well as additional educational webinars being scheduled for the summer period, please go here for more information on our event schedule https://phss.co.uk/events/event_list.asp

Thank you finally to all our valued members, partners, and industry collaborations for your invaluable support in these challenge times this.

On behalf of PHSS Please keep safe and well.

Jenni Tranter, Chair of PHSS – Pharmaceutical & Healthcare Sciences Society.

Reminder regarding key Member benefits:

• Exclusive access to monthly regulatory update synopsis,

• Opportunities to participate in Special interest group collaboration and networking to help generate practical guidance

• We are a voice for all stakeholders in the industry including suppliers and customers

• Access to an extensive document library including white papers, Impact papers and process discussions