Abstract

Monitoring GMPs requires a mainly hypothesis-based framework to efficiently generate data. A wealth of data will be collected and needs to be efficiently processed. The data need to be compared to each other, including to baseline data, and statistically analysed to assess potential adverse effects. This requires minimum common (meta)data standards. To ensure technical comparability, interpretability and quality of GMP monitoring data, we propose harmonisation and data coordination on administrative levels (national, international), process levels (detection methods, site selection) and technical levels (data processing stage, data type, storage media).

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