Is cleaning validation expected to take place when the first batches are produced for commercial use (process validation), even when such batches are produced on a pilot or small scale?

Section 19.3 emphasizes that during all phases of clinical development, including the use of small-scale facilities or laboratories to manufacture batches of APIs for use in clinical trials, procedures should be in place to ensure that equipment is calibrated, clean, and suitable for its intended use. Due to the nature of the manufacturing equipment used (e.g., laboratory glassware, small scale equipment or pilots scale equipment that is easily disassembled for cleaning and inspection), validation of equipment cleaning methods is not expected. Cleaning validation is expected, as per Section 12.7, once API batches are produced for commercial use.