Remote quality and GMP audit
A Remote quality and GMP audit, also known as a virtual audit, is conducting a GMP audit remotely. The remote audit is conducted using communication and electronic technologies Read More >>>
Surface Treatment for Medical Devices
Surface Treatment for Medical Devices Surface roughness level is a parameter of the surface quality commonly measured as the average deviation of the surface profile from the mean line Read More >>>
New drug development and regulation from pre-clinical to clinical trials
[vc_row][vc_column][vc_column_text] 1. Background and history The FDA (U.S Food & Drug Administration) was established in 1901 as a bureau of the Chemistry Department of Agriculture. Five years later, a Read More >>>
Cleaning Validation for Bio-pharmaceutical & Medical Device
Background The definition of "clean" is free from dirt, soil or impurities (chemical/microbial). The cleaning process intend to remove dirt, impurities and soil in addition to decontamination of the Read More >>>