Should acceptance criteria for residues be defined for dedicated equipment?

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. 

Equipment Maintenance and Cleaning: 

Equipment and utensils should be cleaned, stored, and, where appropriate, sanitized or sterilized to prevent contamination or carry-over of a material that would alter the quality of the intermediate or API beyond the official or other established specifications.

Where equipment is assigned to continuous production or campaign production of successive batches of the same intermediate or API, equipment should be cleaned at appropriate intervals to prevent build-up and carry-over of contaminants (e.g. degradants or objectionable levels of micro-organisms).

Non-dedicated equipment should be cleaned between production of different materials to prevent cross-contamination.

Acceptance criteria for residues and the choice of cleaning procedures and cleaning agents should be defined and justified. 

Residual materials can be carried over into successive batches of the same intermediate or API if there is adequate control. Examples include residue adhering to the wall of a micronizer, residual layer of damp crystals remaining in a centrifuge bowl after discharge, and incomplete discharge of fluids or crystals from a processing vessel upon transfer of the material to the next step in the process. Such carryover should not result in the carryover of degradants or microbial contamination that may adversely alter the established API impurity profile. 

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.

Written procedures should be established for cleaning of equipment and its subsequent release for use in the manufacture of intermediates and APIs. Cleaning procedures should contain sufficient details to enable operators to clean each type of equipment in a reproducible and effective manner. These procedures should include:

• Assignment of responsibility for cleaning of equipment;
• Cleaning schedules, including, where appropriate, sanitizing schedules;
• A complete description of the methods and materials, including dilution of cleaning agents used to clean equipment;
• When appropriate, instructions for disassembling and reassembling each article of equipment to ensure proper cleaning;
• Instructions for the removal or obliteration of previous batch identification;
• Instructions for the protection of clean equipment from contamination prior to use;
• Inspection of equipment for cleanliness immediately before use, if practical; and
• Establishing the maximum time that may elapse between the completion of processing and equipment cleaning, when appropriate. 

Should acceptance criteria for residues be defined for dedicated equipment?