EU GMP Annex 1 Volume 4: Laying Supply Chain Foundations That Bring Confidence To Compliance

The European Union's Good Manufacturing Practice (EU GMP) Annex 1 has fundamentally redefined the standards for manufacturing sterile medicinal products globally. While the goal—enhancing public health protection through improved contamination control—is clear, the path to compliance, which officially began on August 25, 2023, has presented complex strategic and operational challenges for many manufacturers. Compliance isn't solely the finished product manufacturer's burden; it requires a collective commitment from all supply chain stakeholders, especially regarding the adoption of a robust Contamination Control Strategy (CCS).

Understanding this industry-wide mandate, the white paper details a strategic framework built on four key pillars: people, communication, process, and continuous improvement. Applying this framework allows companies to systematically re-engineer systems and culture, ensuring contamination control is embedded at every level, from centralized leadership to individual employee responsibility via clear operating procedures and a commitment to ongoing enhancement. By prioritizing a "forever" lifecycle approach to process control, manufacturers can move beyond initial implementation hurdles and achieve long-term compliance confidence. Discover the full details on this integrated approach to meeting the rigorous demands of Annex 1.