Analytical Quality by Design Enabled Green RP‐HPLC Method Development and Validation for the Simultaneous Quantitation of the Cleaning Residues of Osimertinib, Binimetinib, and Erdafitinib: An Approach to Prevent the Cross‐Contamination in Shared Facilities of Pharmaceutical Manufacturing

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Validated green HPLC method quantifies drug cleaning residues, highlighting cross-contamination risks in facilities.

The implemented method successfully quantifies residues, achieving a limit of detection at 0.5 µg/mL for multiple drugs.
Utilizing a green solvent, methanol, resulted in an AGREE score of 0.72, indicating a reduced environmental impact.
Robust method performance was ensured through Taguchi screening and Box–Behnken optimization for chromatographic variables.
The recovery assessment from surfaces effectively aligned with European Medical Agency guidelines, ensuring cleaning validation adequacy.

Jain et al. (2025) studied this question.

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