Cleaning validation (CV) is a Good Manufacturing Practices (GMP) requirement in manufacturing of drug substances and drug products. Liquid Chromatography with UV detection is a common choice for cleaning verifi cation studies for most drugs at sensitivity levels of approximately 20–50 ng/mL. For highly potent drugs, CV methods to reach sensitivity levels of low ng/mL can be implemented using UV...

High quality of data warehouse is a key to make smart strategic decisions. The data cleaning is program that performs to deal with the quality problems of data extracted from operational sources before their loading into data warehouse. As the data cleaning can introduce errors and some data require manually clean, there is a need for an open user involvement in data cleaning for data warehouse...

The validation of surface-recovery methods is a pre-requisite for residual determination of cleaning effectiveness in process validation studies. These methods should be challenged in the laboratory using pilot-scale controlled conditions in order to evaluate the suitability for their intended use. Different swabbing techniques have been studied and compared with rinse method for 7 microorganis...

A method for ethyl carbamate (EC) determination in alcoholic beverages and soy sauce was developed by GC-MS. We adopted the diatomaceous earth solid-phase extraction (SPE) column and elution solvent of ethyl acetate/diethyl ether (5:95 v/v) for sample cleaning. The in-house validation showed the limit of quantification (LOQ) was 5.0 μg/kg. In the accuracy assay, the total average recovery for w...