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 [...]
The process of pharmaceutical drug products registration in Israel The main regulatory body in the pharmaceutical administration in Israel is the Registration Department of the Israeli Ministry of Health [...]
The process of pharmaceutical drug products registration in Israel The main regulatory body in the pharmaceutical administration in Israel is the Registration Department of the Israeli Ministry of Health [...]
The medical and pharmaceutical industries are involved with new product development and manufacturing (such as medical devices & products, medicines, and combinations thereof). Risk management is a regulatory [...]
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 [...]
