Cleaning Validation for Pharmaceutical Manufacturing

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.

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