21 CFR 211.67(a) requires that any equipment, including dedicated and multipurpose equipment, is “cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.” You must therefore ensure that residues (e.g., active ingredients, cleaning agents) are adequately removed product contact surfaces of all equipment during product changeovers and/or between production campaigns, depending on the types of materials and surfaces in use.
Cleaning procedures should be well-documented and consistent for their intended use. Cleaning validation programs should provide assurance that residues are effectively removed product contact surfaces, and manufacturers should select test methods that demonstrate their effectiveness. FDA does not provide extensive guidance on conducting cleaning validation but does recommend consulting guidelines published by various trade and professional associations for additional information (e.g., International Society for Pharmaceutical Engineering, Parenteral Drug Association).
