Cleaning validation: quantitative estimation of atorvastatin in production area.

Unlabelled: Carefully designed cleaning validation and its evaluation can ensure that residues of active pharmaceutical ingredient will not carry over and cross-contaminate the subsequent product. UV spectrophotometric and total organic carbon-solid sample module (TOC-SSM) method was developed and validated for the verification and determination of atorvastatin residues in the production area and to confirm the efficiency of the cleaning procedure as per ICH guideline. Atorvastatin was selected on the basis of a worst-case rating approach.