Cleaning Validation Analysis Support for Pharma Production

Our analytical scientists provide cleaning validation analysis from our GMP compliant laboratories. We ensure that fit-for-purpose analytical methods are specific for the substances being assayed and suitable to detect contaminants at the specified ARL for an appropriate level of cleanliness (sensitivity). Our cleaning validation analytical programs include method development (or method transfer) and method validation where we focus on the critical aspects of LOD, LOQ, precision, linearity, selectivity, recovery-spiking, consistency of recovery.

With many years of experience in partnering with manufacturers around the world, we are able to develop highly specific methods for the more common residues, but also for the more complex, such as reaction by-products and degradation species. Our Good Manufacturing Practice (GMP) compliant laboratories are equipped with a wide range of techniques for both non-specific and specific API assays including high pressure liquid chromatography-mass spectrometry (HPLC-MS), ion chromatography (IC), inductively coupled plasma spectroscopy with mass spectrometry (ICP-MS) or optical emission spectroscopy (ICP-OES) detection. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.