Regulatory expectations for cleaning validation in pharmaceuticals focus on ensuring that residues from previous products, cleaning agents, and microorganisms do not compromise patient safety, product quality, or regulatory compliance. Authorities such as the US FDA, EMA, WHO, and PIC/S expect companies to implement a robust, science- and risk-based cleaning validation program aligned with GMP principles.
A key expectation is a documented lifecycle approach. Firms must define cleaning processes, justify them scientifically, validate them, and maintain them through ongoing verification. This includes detailed procedures, validated analytical methods, and clear acceptance criteria for product residues, cleaning agents, and microbiological contamination. Limits must be toxicologically and pharmacologically justified, often using health-based exposure limits (HBELs) or MACO/Permitted Daily Exposure concepts.
Regulators expect a thorough risk assessment to identify worst-case products and equipment. Factors include toxicity, potency, solubility, cleanability, batch size, and shared equipment complexity. Worst-case selection must be justified and documented, not arbitrary. Campaign length, dirty and clean hold times, and product changeover strategies must be evaluated and validated.