Cleaning Validation for Pharmaceutical ManufacturingBy Alconox
Cleaning validation is a requirement for pharmaceutical manufacturing, which adheres to current good manufacturing practice (cGMP) and quality systems regulations (QSR).
Validation is a documented guarantee that cleaning can be performance 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 includes residue identification, detection, and quantitation.