Cleaning Validation for Pharmaceutical Manufacturing
Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. However, the process can be expedited and the cost reduced if the cleaner supplier can provide support, ultimately allowing pharmaceuticals to get to market faster and at a lower cost.
Cleaning validation is a requirement in industries such as pharmaceutical manufacturing that adhere to current good manufacturing practices (cGMP) and quality systems regulations (QSR). 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
- Sampling method selection
- Setting residue acceptance criteria
- Method validation and recovery studies
- Writing procedures and training operators
To find out more about the basics of cleaning validation and the support services you should seek from your critical cleaning products supplier to optimise cleaning validation process, download this free whitepaper.