Report Significant Changes Per ICH Q1A and Justify Corrective Actions
Understanding the Tip: What constitutes a significant change under ICH Q1A(R2): ICH Q1A(R2) provides clear guidelines for identifying significant changes during stability studies. These include changes in assay values, impurity levels, physical characteristics (e.g., appearance, dissolution), or microbial limits. When a result crosses predefined thresholds, it must be reported as a “significant change” and evaluated…
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