New mRNA-based drugs platforms for cancer treatment The successful development of mRNA (messenger ribonucleic acid) based on anti-COVID 19 vaccines happened in a relatively short time through many [...]
Introduction "Nonconformity" investigation is a very common term used in production and product quality improvement areas in the pharmaceutical and medical devices industries. It is mandatory and a [...]
What is software validation? Software validation is part of the computerized systems validation (CSV) process. Computerized systems validation is defined as documented evidence with a high degree of [...]
Introduction Weighing of raw materials, products, reagents, excipients and other product related materials is an area which has risks in the biotechnology and pharmaceutical industries. Any weighing mistake [...]
Background Good Storage Practice (GSP) and Good Distribution Practice (GDP) describe human, veterinary and investigational drug substance and drug product supply chain procedures and standards for assurance of [...]
Background The use of stem cells for therapeutic and clinical applications is a fast growing area in Biotech research and development. Stem cells have the potential to differentiate [...]
Background After a new investigational drug pre-clinical stage 1 is completed, and a US IND (Investigational New Drug application) or EU CTA (Clinical Trial Application) submission to the [...]
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 [...]
[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 [...]
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 [...]
