Technical Tuesday: Contamination Control Strategy – Challenges & Opportunities
25 Oct 2022
5.30-6.30pm SGT | Online
Abstract:
The new revision of the EU GMP Annex 1 for sterile production was just issued on August 2022, and it is already acknowledged as an important challenge for the quality system of any pharmaceutical sterile production. One of the most important implementations is the requirement for the design and issue of the site Contamination Control Strategy document, a 360-degrees plan of the controls, procedures and technologies for the containment of the contamination risk of products and processes. How can such a high-level documentation be designed, assessed and issued? Let’s try and clear some aspects and expectations, when no specific guidelines and benchmarks are now available for such an overriding task.
Led by:
Alessio Rosati, Sterility Assurance Advisor and Associate Partner, PQE Group
Graduated as Biologist, Alessio Rosati holds PhD in Molecular Genetics, with more than 11 years of direct experience in sterile injectable manufacturing and specialised in QC microbiological and Sterility Assurance. As a PQE Sterility Assurance Executive Consultant since 2018, Alessio involved in multiple international projects aimed at bringing pharmaceutical companies to a full compliance with both the main international standards and guidelines related to sterile production, and to optimize their strategies for the containment of contamination risks.