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Hasim Solmaz, Lighthouse

New GMP Annex 1 & Contamination Control Strategy

5 Dec 2024

In his Cleanzone 2024 presentation, Hasim Solmaz introduces the Contamination Control Strategy, focusing on the significant updates following the long-awaited revision of GMP Annex 1.

He explains how the new structure and increased content of the document reflect the evolving needs of the industry. Hasim Solmaz provides an insightful overview of what a contamination control strategy is and how it can be effectively achieved. Through a clear and practical approach, he outlines three key steps to reach this goal: Contamination, Control, and Strategy. This session will guide the audience in understanding the critical elements of a successful contamination control strategy and how to implement it within the operations.

…is the General Manager of Lighthouse Worldwide Solutions EMEA Operations, where he specializes in cleanroom design and management, environmental monitoring systems, pharmaceutical manufacturing, and regulatory compliance. He is the founding chair of the Cleanroom Technologies Society of Turkey (CTS) and serves as the head delegate for ISO TC209, which focuses on cleanrooms and associated controlled environments. Additionally, Hasim chairs the Turkish Standardization Institute (TSE) Mirror Technical Committee 165 on Cleanroom Technologies and contributes as an expert in various ISO TC209 Working Groups. As the Secretary General of the International Confederation of Contamination Control Societies (ICCCS), he represents a global network of cleanroom and contamination control societies from over 20 countries. Hasim is also a faculty member at the Institute of Environmental Sciences and Technology (IEST) Contamination Control Institute (CCI), where he lectures on Cleanroom Classification, Monitoring, Testing, and Certification. For the 2024-2026 term, he will serve as Vice President of Planning on the IEST Executive Board. He is actively involved in several organizations, including IEST, CTS, the International Society for Pharmaceutical Engineering (ISPE), and the Parenteral Drug Association (PDA).