Articles
Cleaning Validation For Pharmaceutical Manufacturing
May 12, 2008
•White Paper: Cleaning Validation For Pharmaceutical Manufacturing
Cleaning validation is a necessary and time consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost of validation can be lowered if the cleaner supplier can provide support, allowing for pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation, as well as discussing the kinds of support services you should seek from your supplier of critical cleaning products in order to optimize your cleaning validation process.
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
•White Paper: Cleaning Validation For Pharmaceutical Manufacturing
