A Generic HPLC/UV Platform Method for Gleaning Verification

摘要

Cleaning validation is a GMP requirement [1 -2] in the pharmaceutical manufacturing of drug substances and drug products. Cleaning verification (CV) must be performed to demonstrate the"cleanliness" of the production equipment [3-4] at the completion of each manufacturing step by visual inspection and the analysis of cleaning swabs or rinse solutions to confirm that the active pharmaceutical ingredient (API) has been adequately removed to pre-established acceptance limits [4-5]. Cleaning validation is a multifunctional program in late-stage drug development and commercial production and requires a thorough understanding of equipment design, contact surfaces, product solubility, and other associated properties in order to establish practical cleaning protocols, acceptance limits, and analytical procedures [4, 6]. The analytical procedures typically used have been reviewed by Pack [4]. They can be non-specific (e.g., gravimetric (residual on evaporation or ROE)) or total organic carbon (TOQ) or product-specific techniques such as ultraviolet spectrometry (UV), ion mobility spectrometry (IMS), or high-performance liquid chromatography (HPLC) using UV, evaporative light scattering (ELSD), charged aerosol detection (CAD), mass spectrometry (MS), or other detectors [4, 6-8].