Analytical Methods for Cleaning Validation

摘要

Residue identification in a pharmaceutical manufacturing environment involves; the cleaner, primary ingredients, excipients, decomposition products, and preservatives. This document is intended to help with the cleaner residue identification. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatography (HPLC), ion selective electrodes, flame photometry, derivative UV spectroscopy, enzymatic detection and titration, or it can involve non-specific methods that detect the presence of a blend of ingredients such as: total organic carbon, pH, and conductivity. The FDA prefers specific methods, but will accept non-specific methods with adequate rationales for their use. For investigations of failures or action levels, a specific method is usually preferable.