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Challenges in Sterile Product Manufacture 2017
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Challenges in Sterile Product Manufacture 2017

When: 8th June 2017
9:00 AM
Where: The Mere Golf and Spa
Chester Rd
Knutsford WA16 6LJ
United Kingdom
Contact: Tamsin Marshall
+44 (0)1793 824254

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As new pharmaceutical, biological products, advanced medicinal therapies and manufacturing technologies develop there
are issues of clarity in GMP guidance required. GMP chapters and Annex guidance’s cannot be prescriptive on all issues and allow for development and innovation. In addition some flexibility is allowed to facilitate product and pharmaceutical processing experts to develop rationale, methodology, good practice with procedures and acceptance criteria to suit novel and specialized medicinal and therapeutic products. 


To support these aims GMP relies on interpretation of guiding principles that have patient safety as a focus together with application of Pharmaceutical Quality systems (PQS), Quality Risk Management (QRM) and Quality by Design (QbD) that reinforce a risk based approach in sterile product manufacturing and associated non-sterile components/ APIs. EU GMP Annex 1 revision will clarify some current issues requiring clarity in GMP but still there will be a need to apply principles where prescriptive test or best practice guidance remains open to application and interpretation.  


This PHSS GMP ‘clarity of issues’ conference brings together, key opinion leaders, subject matter experts together with Ex and current GMP regulatory inspectors to debate and provide clarity on areas and topics of GMP where interpretation is challenging and shared experience within the neutral platform of the PHSS conference provides an opportunity to understand approaches and expectations to GMP compliance.


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Full programme available here




Confirmed Speakers:


Andrew Hopkins - MHRA Expert GMP inspector and leader of Annex 1/ PICS revision working group

Brian Cullinan - Alexion

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