Is cleaning qualification sufficient? Would cleaning validation be expected once the API manufacturing was commercial and not clinical?

Section 12.7 emphasizes that “cleaning procedures should normally be validated”. This applies to API commercial processes. Cleaning or any validation is pretty much recognized as being generally inappropriate for APIs for
Use in Clinical Trials. Section 19.3 states: “…procedures should be in place to ensure that equipment is calibrated, clean, and suitable for its intended use”.