Link to EAHP Statements
Section 3 – Production and Compounding: Statements – tba
Abstract
Risk-based approaches have gained significant importance across all sectors in recent years. The primary goal of these systems is to prevent microbiological contamination of pharmaceutical products. However, even with a robust system in place, it is crucial that all operators involved in quality-relevant work understand and adhere to these programs and measures. As a result of successive revisions to the draft EU GMP Annex 1, the term “Contamination Control Strategy (CCS)” has gained recognition alongside “Quality Risk Management (QRM).” This is noteworthy since the foundation of the CCS is built on QRM principles. The new Annex 1 now clearly requires the overarching interlinking of individual measures with the Contamination Control Strategy. Despite the second revision of draft Annex 1 by the IWG, there appears to be a continued need for practical guidance on establishing and documenting an appropriate CCS. This course aims to address all critical aspects of controlling microbiological contamination. It will cover recent updates on the new Annex 1 status and identify potential challenges in its implementation. Additionally, it will explore variations in CCS understanding and implementation practices based on factors such as the types of processes, product manufactured (sterile or non-sterile), manufacturer process knowledge and expertise, and any existing contamination control programs. Interactive discussions will provide attendees an opportunity to share experiences, identify barriers, and brainstorm ways to evaluate the risks associated with microbiological and particle monitoring. The course will also recognize the valuable contributions of hospital pharmacists in the modern healthcare landscape.
Learning objectives
After the session, the participant should be able to:
– Understanding an overview of changes in the new Annex 1 as well as their implications and how to interpret them.
– Team creation, methodology, format and content in preparing the Contamination Control Strategy.
– Developing an effective transversal quality performance Contamination Control Strategy dashboard.
Educational need addressed
This seminar aims to equip hospital pharmacists with the knowledge and tools necessary to defining the threshold that would require review/evaluation of the Contamination Control Strategy.
Keywords
Risk assessment, contamination, development of Contamination Control Strategy, pharmaceutical environments.