Cleaning Validation for Pharmaceutical Manufacturing

| February 13, 2018

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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.

Spotlight

Leem

The Leem, the companies of the drug, brings together the companies of the sector of the pharmaceutical industry in France. Founded more than 130 years ago, Leem now has nearly 270 member companies, which account for nearly 98% of the total turnover of the drug in France. The pharmaceutical industry employs 100,000 people in more than 150 trades, and has recruited 10,000 employees a year for the past 10 years.

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Spotlight

Leem

The Leem, the companies of the drug, brings together the companies of the sector of the pharmaceutical industry in France. Founded more than 130 years ago, Leem now has nearly 270 member companies, which account for nearly 98% of the total turnover of the drug in France. The pharmaceutical industry employs 100,000 people in more than 150 trades, and has recruited 10,000 employees a year for the past 10 years.

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