Someone says: “We’re adding Product X to this line.” The equipment is validated. Cleaning protocols are locked in. Residue limits are established. The question hits fast: does the existing cleaning validation still work? A new product can change the cleaning picture fast. Different active ingredients have different solubility profiles. Some leave harder-to-remove residues. Some carry a lower permitted daily exposure (PDE), which tightens the acceptable residue limits on shared equipment. Get the assessment wrong and you are either over-cleaning for no reason or under-cleaning with compliance risk. Here is how to work through it — with structure, without getting lost. What the Regulations Actually Say The 2025 NMPA Cleaning Validation…