Thursday, 14 February 2013

Pharmaceutical Cleaning Validation


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
The above is an extract from an article on cleaning validation, published by Pharmaceutical Online. 

Posted by Tim Sandle