What question did this study set out to answer?

The aim is to define regulatory requirements and methodologies for data trending related to contamination control.

Data Analysis/Trending/Pattern recognition for Annex 1 Contamination Control Strategy

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Technical presentation reviews regulatory trends and data analysis for contamination control strategies, highlighting implications.

The aim is to define regulatory requirements and methodologies for data trending related to contamination control.
Review of regulations including EMA Annex 1, WHO, FDA, and PDA technical reports.
Identification of triggering events for data trending and root cause analysis.
Evaluation of trending tools such as control charts, quantiles, and regression analysis.
Trending data is now a regulatory requirement under EMA Annex 1.
Identification of key tools necessary for effective contamination control processes.
Emphasis on the importance of accurate and reliable data for process improvement.

Susan Cleary (2026) studied this question.

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