Guidelines for the process of cosmetics registration/submission in Israel The Department that is responsible to assure the safety and quality of cosmetics products for the Israeli market is [...]
Medical device surface treatment Surface roughness level is a parameter of the surface quality commonly measured as the average deviation of the surface profile from the mean line (Ra). [...]
What is Validation? Validation is documented evidence that demonstrates a process/equipment/system/software/procedure which complies with specifications, criteria and requirements defined in a pre- approved protocol and detailed in: Specifications Definitions [...]
Background and history In 1938, the FFDCA (Federal Food, Drug and Cosmetic Act) granted FDA cosmetic products and ingredients regulation authorization. The statutory provisions of the FFDCA addressing cosmetics [...]
Background Good Storage and Distribution Practice (GSP/GDP) describes human, veterinary and investigational drug substance and drug products supply chain procedures and standards in order to assure the biological/pharmaceutical product [...]
[vc_row][vc_column][vc_column_text] 1. Introduction Weighing raw materials, product, reagents, excipients and other product related materials is a risk procedure in the Biotechnology and Pharmaceutical areas. Any weighing mistake in case [...]
What is software validation? Software Validation is part of the computerized system validation (CSV) process. Computerized system validation defined as a documented evidence with a high degree of assurance [...]
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 [...]
