Meeting Annex 1 Regulations: A Proactive Approach To Regulatory Compliance

By Victoria Morgan, Sr. Director, Commercial Go-to-Market

A major European contract manufacturing organization (CMO) producing diverse biologic drugs recognized the significant impact of the August 2023 EU GMP Annex 1 revision. This update, focused on modernizing sterile product manufacturing, particularly packaging and contamination control, mandates stricter quality assurance. Driven by the need for enhanced patient safety, the CMO proactively assessed component quality, specifically stoppers, to ensure their customers' products meet the new EU regulatory standards. This involved balancing optimal product quality with value to guarantee compliance and minimize contamination risks. The CMO's approach aligns with both EU and FDA's emphasis on reducing recalls related to sterility and particulate contamination.