Annex 1: Changes that will hit EM monitoring programmes

摘要

Annex 1 was introduced to prevent contamination in the final product. The updates include many clarifications and additional instructions for sterile manufacturers to consider, from pharmaceutical quality systems and guidance for using Quality Risk Management (QRM) principles to the concept of a contamination control strategy. One significant aspect of the contamination control strategy is the environmental monitoring programme. Annex 1 requires a written sampling plan for your environmental monitoring, and that your contamination control strategy should directly influence your EM programme. This plan should provide you with meaningful data, providing assurance that cleanrooms are appropriately clean and that you are able to detect excursions which may provide a risk to product quality.