Cleaning validation and verification are based on the premise of risk management. Several regulatory and guidance documents make this clear. The International Conference on Harmonization's (ICH) guideline on risk management outlines several approaches to making and documenting risk-based decisions (1). It clearly states that risk management should be based on scientific knowledge and that personnel should evaluate the effect of potential failures on the patient. In addition, it notes that the levels of effort, formality (e.g., use of tools), and documentation of the quality risk-management process should be commensurate with the level of risk.
The US Code of Federal Regulations states that equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product (2). In accordance with 21 CFR 211.67, ICH issued recommendations on equipment maintenance and cleaning (Q7A, Sections 5.20–5.26) for compliance and safety that include similar, but more detailed requirements (3).
The US Food and Drug Administration's 1993 guidance on cleaning inspections states that for a swab method, recovery should be established from the surface (4). The guidance contains no specific requirements about how to establish these recovery estimates, or the acceptance limits. It is up to the manufacturer to document the cleaning rationale (i.e., process and acceptance limits) for maintaining the quality and purity of the drug product being manufactured.