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Cleaning validation is a requirement in industries such as pharmaceutical manufacturing which adhere to Good Manufacturing Practice (GMP) and Quality Systems Regulations (QSR), and is specific to the cleaning method and cleaner employed.
Simply stated, validation is a documented guarantee that cleaning can be performed reliably and repeatedly to satisfy a predetermined level of cleanliness. Validation is achieved by demonstrating at least three times that the cleaning process removes residues down to acceptable levels. Testing for acceptable residues includes:
• Residue identification
• Residue detection method selection
• Sampling method selection
• Setting residue acceptance criteria
• Methods validation and recovery studies
• Writing a procedure and training operators
After establishing three or more times that a process can be repeated reliably to remove residues down to acceptable levels, a program can be implemented to maintain the state of validation where only periodical retesting is required. Changing any part of the cleaning procedure, including the cleaner, mandates revalidation. This entails first cleaning the new cleaners or methods, collecting data, and then cleaning the equipment with the prior validated process before using the equipment. These previously validated steps need to be followed until the new procedure is fully validated.
