Yes. Regardless of whether equipment is dedicated or not, it is expected that acceptance criteria for residues be defined and that the equipment be cleaned at appropriate intervals to prevent build-up and carry-over of contaminants. Intervals can be based on number of batches, product change-over, time, etc. [ICH Q7, Sections 5.22, 5.23, 5.24, 5.25, 8.50].
Cleaning intervals and acceptance criteria should be established based on an understanding of the process/reactions/degradation, taking into account solubility, potency, toxicity, etc. Establishment of acceptance criteria does not necessarily imply sampling and testing after every cleaning. Visual inspection of equipment for cleanliness is an expectation of [ICH Q7, Section 5.21]. Where validation data has confirmed effective cleaning, cleaning procedures should be monitored at appropriate intervals [ICH Q7, Section 12.76].
