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Cleaning Validation for Pharmaceutical Manufacturing

Cleaning validation is a requirement in industries such as pharmaceutical manufacturing that adhere to current Good Manufacturing Practice (cGMP) and Quality Systems Regulations (QSR). It is specifi c 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 consistently that the cleaning process removes residues to acceptable levels. Testing for acceptable residues includes:
• Residue identification
• Residue detection and quantitation method selection
• Sampling method selection
• Setting residue acceptance criteria
• Method validation and recovery studies
• Writing procedures and training operators.

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