A Guide to Annex 1 Requirements For Particle Monitoring

By Frank Panofen, PH.D., Maurizio Della Pietra, Daniele Pandolfi, Anna Campanella, Giulia Artalli, and Paola Lazzeri

The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.

In the Principle section (Section 2), the guidelines indicate risk assessments should be performed for each area to ensure they are optimized, validated and qualified. Quality objectives are set and fulfilled through the implementation of quality assurance (QA) systems. These systems are controlled via scientific evaluation of risks in accordance with quality risk management (QRM) principles. Monitoring devices provide the reliable, actionable data necessary to support scientific evaluation, and are best utilized as part of a network of failsafes to prevent unforeseen events (i.e., interventions, system deterioration) from impacting product quality.

There are no assumptions when determining risk. All decisions and methodology must be justified in a document called the contamination control strategy (CCS), referred to multiple times throughout Annex 1. The CCS should be an active document at all times for its continuous improvement and application.